What You Should Know: 

– 23andMe, a genetic health and biopharmaceutical company launched Health Action Plan, a new digital tool for 23andMe+ members that draws on results from genetic reports, health history survey data, as well as blood and biomarker data to provide a uniquely tailored set of health recommendations out of hundreds of options.

– Health Action Plan is a helpful first step when it comes to prevention and early risk detection. It offers customers specific actions and next steps on their health journey. 

– 23andMe reminds customers that they should not use Health Action Plan to replace a visit to their primary healthcare provider.

Tailored Recommendations

Each recommendation is evidence-based, and written and reviewed by a team of scientists, genetic counselors, and medical experts at 23andMe. The new digital tool draws on a customer’s genetic health reports and their self-reported health history. Together, this data helps inform tailored recommendations, prioritizing the most critical steps for an individual to take. The more information a customer provides, the more personalized their recommendations will become.

In addition to suggestions on altering activities like sleep, diet, and exercise, other recommendations include learning about potential new treatments or activities for conditions, as well as entering additional health data, like diagnoses or family history, to further personalize recommendations. Eligible customers may also receive recommendations for further clinical action, like getting a blood test, which can now be coordinated directly through 23andMe. 

Testing managed through the 23andMe platform provides a fast and convenient way to order, pay, and schedule an appointment at a local lab, and receive results and a personalized clinical analysis in 3-5 business days.* The biomarker data, in addition to genetic data, can help identify possible health risks for individuals to take any necessary actions. Customers can also connect with a clinician to discuss their results.
**Blood testing through 23andMe is not available in NY, NJ, RI, OK, HI, PR

We are living in a mental health epidemic. An estimated 26 percent of Americans ages 18 and older – about one in four adults – suffer from a diagnosable mental disorder in a given year. Among mental disorders, cases of PTSD are on the rise. Roughly five percent of American adults suffer from PTSD in any given year and more than 13 million Americans reported PTSD in 2020 – most of whom are women. Standard PTSD treatments most often come in the form of pharmacotherapy or psychotherapy and include a cocktail of anti-depressant drugs, prolonged exposure therapy, eye movement desensitization and reprocessing and cognitive behavioral therapy. These treatment modalities have proven effective for many patients, and yet, PTSD is a unique journey for every patient, each of whom needs specialized treatment plans to meet their needs. 

A 2022 academic review showed that the effect sizes during clinical trials of both new psychotherapies and pharmacotherapies in mental disorders were small in comparison to the previously adopted ‘treatment as usual’ or a placebo. This study demonstrated that while current therapies work for many patients, they are not favored by all patients. Pharmacotherapy options often result in adverse side effects which can impact treatment retention, while psychotherapy can prove challenging for patients when they relive their experiences. We must embrace the latest medical innovations that have proven themselves in other areas of care to provide a third option for patients in need of a solution. 

Unlocking Biomarker-Based Mental Disorder Treatment 

As an objective and measurable biological signal of bodily processes, biomarkers are indications of conditions and diseases and have been used successfully throughout fields of medicine. From indicating of the presence of disease, to clinical trial matching, to measuring the efficacy of new and novel treatments, and enabling personalized treatment. Today, researchers utilize as many as seven distinct categories of biomarkers, including diagnostic, predictive and monitoring. 

While biomarkers have been used to advance many areas of care, the creation and adoption of brain biomarkers to identify, treat and manage neurological disorders has remained comparatively low due to several biological barriers. Biomarkers rely on blood, tissue, or urine samples, while neurological biomarkers are present in cerebral spinal fluid (CSF) but are often at undetectable levels in blood. While biomarkers can be developed and measured using various biological samples, this requires invasive procedures and consequently is not a viable treatment for many patients. The brain is also protected by the blood–brain barrier, shielding this crucial organ from harmful substances circulating in the bloodstream, making brain activity inaccessible to a blood test. 

Recognizing the potential value of biomarker-based neurological treatment and management, clinicians and product innovators have utilized existing technologies used to monitor brain activity, which include electroencephalogram (EEG) and functional magnetic resonance imaging (fMRI). EEG is a low-cost modality that measures brain electrical activity on the scalp through a patient-worn cap with electrodes, however, EEG is not able to measure electrical activity in deep brain regions. On the other hand, fMRI scanners are used to measure blood oxygenation (known as BOLD signal) in deep-lying specific brain regions but are expensive and complex to operate. 

While progress has been made in developing EEG-only solutions for brain biomarkers, this has been stalled by the inability to measure deep brain activity. As a result, the field of neurology was left for decades without a scalable and effective solution for monitoring deep brain activity, limiting our ability to diagnose and treat mental disorders. But recently, researchers made breakthrough discoveries to combine EEG and fMRI into scalable, affordable and portable solutions. This innovative, scientific mechanism will soon become a leading modality used to treat mental disorder treatment.  

In 2014, a study in NeuroImage introduced a novel imaging approach using fMRI-inspired EEG analysis. The results introduced a neurological biomarker that is calculated by identifying EEG features that correlate to activation levels of specific brain region processes associated with mental disorders as seen in fMRI. The biomarker was developed by performing a series of simultaneous acquisitions of datasets of EEG and fMRI under specific psychological paradigms. The EEG and fMRI voxel data of brain regions associated with mental disorders of interest were then fused using advanced statistical models to produce the biomarker. 

This development may mark a significant breakthrough for mental disorder care, transforming neuro-biomarkers from inaccessible bio-based signals to technology-powered brain activity indicators. For the first time, monitoring of biomarkers of activity associated with deep brain regions in a non-invasive, scalable and affordable model has become a reality and the field of mental disorder care is set for transformation. 

Mirror, Mirror on the Wall: Using Biomarkers to Follow Brain Activity 

Similar to biomarkers in other medical applications, neuro-biomarkers can shed light on the inner workings of brain activity without directly altering the neural state. In doing so, we can better understand the underlying mechanisms of mental disorders in response to triggers and design better treatments. An amygdala-based biomarker is just the first example of many that demonstrate the power of biomarker-based treatment for specific brain regions. 

There are thousands of published studies indicating the amygdala’s role in mental disorders. The amygdala is the control center of the fight-flight-freeze response – a response to stressful, frightening or dangerous events that dictates how the body responds to danger. The hyper-reactive amygdala has been clinically shown to play a significant role in PTSD, General Anxiety Disorder, Bipolar Disorder, Schizophrenia, and Borderline Personality Disorder. 

By utilizing tech-powered biomarker-based treatments that are based on specific brain regions – such as the amygdala – clinicians can provide a real-time data-based approach to treatment with greater clarity into a patient’s underlying mechanisms. With access to measurable insights, clinicians can provide customized treatment and with accurate and measurable insights, can power our approach to mental disorder care. In the long term, this can be utilized across a variety of mental disorders and better determine the best course of treatment, whether psychotherapy or pharmacotherapy and monitor their progress to enhance overall outcomes. 

We are beginning to see a monumental shift in mental disorder treatment. Embracing brain region or mechanism-specific neurological biomarkers to treat dysregulated underlying brain mechanisms, provides a third option of care that can augment existing pharmacotherapy and psychotherapy modalities. As a tech-based solution, neurological biomarkers can be used as a core asset along with the advances in automation and machine learning and create modalities that will continue to evolve with time and address other neurological conditions beyond mental disorders. In doing so we can continue to support mental healthcare professionals in providing patients the most effective and impactful treatment.  

About Oded Kraft 

Oded Kraft is the Co-Founder and CEO of GrayMatters Health and has over 25 years of international experience in global high-tech innovation and business development of both startups and large corporates that focus on medical device innovation. Before establishing GrayMatters Health, Mr. Kraft worked in executive business development roles within Roche and GE Healthcare and has also served on the board of several medical device companies in the EU, Israel and the US. Mr. Kraft holds an MBA and a BSc in Electrical Engineering from Technion Institute of Technology in Haifa, Israel.

What You Should Know:

• A team of leading clinicians, engineers, and neuroscientists has made a groundbreaking discovery in the field of treatment-resistant depression. By analyzing the brain activity of patients undergoing deep brain stimulation (DBS), a promising therapy involving implanted electrodes that stimulate the brain, the researchers identified a unique pattern in brain activity that reflects the recovery process in patients with treatment-resistant depression.
• This pattern, known as a biomarker, serves as a measurable indicator of disease recovery and represents a significant advance in treatment for the most severe and untreatable forms of depression. The team’s findings, published online in the journal Nature on September 20, offer the first window into the intricate workings and mechanistic effects of DBS on the brain during treatment for severe depression.

Modifying Brain Stimulation Techniques to Combat Depression

Deep Brain Stimulation (DBS) entails the placement of slender electrodes in a specific region of the brain to administer gentle electrical impulses, akin to a pacemaker. Although DBS has obtained approval and has been utilized for movement disorders like Parkinson’s disease for an extended period, its application in treating depression remains experimental. This research represents a critical advancement towards harnessing objective data acquired directly from the brain through the DBS device to inform healthcare professionals about a patient’s response to treatment. This valuable information can facilitate the adjustment of DBS therapy, customizing it to match each patient’s individual response and enhancing the efficacy of their treatment.

The researchers have now demonstrated the feasibility of monitoring the antidepressant effect continuously throughout the treatment process, offering healthcare providers a tool somewhat analogous to blood glucose testing for diabetes or blood pressure monitoring for heart disease. It provides real-time insight into the patient’s condition, distinguishing between normal day-to-day mood fluctuations and the potential onset of a depressive episode relapse. The research team, comprising experts from the Georgia Institute of Technology, the Icahn School of Medicine at Mount Sinai, and Emory University School of Medicine, employed artificial intelligence (AI) to detect changes in brain activity that coincided with patients’ recovery.

This study, funded by the National Institutes of Health through the Brain Research Advancing Innovative Neurotechnologies (BRAIN) Initiative, involved ten patients grappling with severe treatment-resistant depression, all of whom underwent the DBS procedure at Emory University. A novel DBS device was employed to record brain activity. Analysis of these brain recordings over a span of six months led to the identification of a shared biomarker that exhibited changes as each patient recovered from depression. Following six months of DBS therapy, 90 percent of the subjects experienced a substantial improvement in their depression symptoms, with 70 percent no longer meeting the criteria for depression.

“The use of explainable AI allowed us to identify complex and usable patterns of brain activity that correspond to a depression recovery despite the complex differences in a patient’s recovery,” explained Sankar Alagapan PhD, a Georgia Tech research scientist and lead author of the study. ”This approach enabled us to track the brain’s recovery in a way that was interpretable by the clinical team, making a major advance in the potential for these methods to pioneer new therapies in psychiatry.”

What You Should Know: 

– ALZpath, a developer of blood-based diagnostic biomarker testing for Alzheimer’s disease detection receives funding from the Alzheimer’s Drug Discovery Foundation (ADDF)’s Diagnostics Accelerator to accelerate the clinical availability  of ALZpathDx as a laboratory developed test (LDT). 

– ALZpathDx is a novel, proprietary assay for blood-based measurement of phosphorylated tau at threonine 217 (pTau217), a highly accurate, diagnostic biomarker for Alzheimer’s disease. The assay is performed on the Quanterix Simoa HD-X immunoassay analyzer.

Accelerate Analytical and Clinical Validation of ALZpathDx

ALZpathDx has been launched for clinical use as laboratory-developed test (LDT). Evaluation in independent clinical cohorts with multiple co-morbidities is currently being established to advance to an in-vitro diagnostic (IVD). The investment comes at a pivotal time in the advancement of Alzheimer’s disease treatments, with Biogen and Eisai’s Lecanemab (LEQEMBI®) recently receiving traditional FDA approval, ushering in a new era for the next generation of Alzheimer’s treatments. A critical barrier to widespread availability and use of these and other treatments to follow is the difficulty in diagnosing Alzheimer’s patients, particularly in the early stages of disease onset, when such treatments may have the most profound impact.

Biomarkers Enable the Next Phase of Clinical Care

Cognitive testing has traditionally been the primary method to diagnose Alzheimer’s disease, however, relying solely on cognition has limitations because patients only show symptoms after significant changes have occurred in the brain. Historically, the only definitive way to confirm an Alzheimer’s disease diagnosis was through autopsy.

As a more accessible and simple approach to understanding brain health, many are turning to biomarkers in peripheral fluids. In the last decade, cerebrospinal fluid (CSF) biomarker assessments have become an important diagnostic tool alongside bioimaging. However, obtaining CSF has its own challenges. Today blood-based biomarkers is considered the future of diagnosing Alzheimer’s disease. pTau217 outperforms other Alzheimer’s diagnostic biomarkers, including CSF and PET scans, to predict the likelihood of Alzheimer’s disease prior to the onset of symptoms.

What You Should Know:

– Sonde Health, a Boston, MA-based health technology company committed to bringing accessible health monitoring to everyone raises $19.25 million in a Series B investment round led by Partners Investment, with participation from NEOM Company, KT Corporation, and existing investors, including co-founder PureTech Health and M Ventures.

– The AI vocal biomarker company will use the funding to accelerate its commercial growth, expand its platform into new health conditions, and enter new geographies.

Enterprise Vocal Biomarker Technology

Co-founded by PureTech Health, Sonde Health has the largest and most diverse health-labeled voice dataset with over 1.2 million voice samples from over 85,000 subjects on 4 continents. Sonde is the only vocal biomarker company to offer AI/machine learning-based monitoring products for multiple health conditions and to have developed the ability to embed its technology into device chipsets for passive and safe health monitoring through voice.

Today, Sonde provides its enterprise vocal biomarker technology to companies across several health verticals, including telehealth, pharmaceutical, remote patient monitoring, and consumer/medical devices. Sonde licenses its platform to customers globally in two ways:

Health Checks

Respiratory Fitness: Sonde’s platform can detect and monitor respiratory health conditions, like asthma, from 6 seconds of voice. Patients are engaging with Sonde’s respiratory fitness health checks 2+ times per week.

Mental Fitness: Sonde’s platform can detect and monitor evidence of depression and anxiety from 30 seconds of voice. Patients are engaging with Sonde’s mental fitness health checks 3+ times per week.

Vocal Biomarker Development

MCI, COPD, General Health: Sonde is developing novel vocal biomarkers using its proprietary “research-build-validation” methodology with clinical partners.

“Digital biomarkers are becoming a mainstay in healthcare. Today’s healthcare companies are realizing how vocal biomarkers can engage people earlier in their health. The data and insights found in voice can power health monitoring and patient stratification so issues can become apparent well before a costly medical event occurs,” said David Liu, CEO of Sonde Health. “With voice and any listening device, accessible and effective health monitoring can be made available to the majority of the world.”

For most adults, the first sign of dehydration is feeling thirsty. However, as we age, our thirst sensation naturally weakens, which means older people may not know that they need more fluids until they’re typically underhydrated, putting them at a higher risk of clinical dehydration.

Other age-related physiological changes can also impact a person’s ability to remain hydrated, such as a decline in kidney function. Indeed, renal function begins to diminish around the age of 50. This is due mainly to accumulated oxidative damage, which affects cellular function and increases the risk of nephrosclerosis and loss of renal reserve and mass. Additionally, older people generally have a lower percentage of water in their bodies, which puts them at greater risk of dehydration, especially in hot weather.

Even older people in senior living or assisted care environments can be at increased risk of dehydration and severe health consequences. For instance, dementia patients in a nursing home may not be able to communicate to staff that they’re thirsty, which results in inadequate fluid intake. Moreover, many assisted living communities are plagued with issues like understaffing and language barriers that can impact the proper hydration of elderly residents.

All these issues and others can result in greater hospitalizations for this population group simply due to dehydration. They can also lead to ongoing health issues such as kidney stones and cardiovascular disease, limiting the body’s overall ability to maintain good health.

Thirst is an inexact indicator.

Ensuring an appropriate hydration level is essential for a healthy life at any age. So why aren’t we doing a better job of monitoring and measuring hydration? There are many reasons.

One is that it can be difficult to instill and maintain good hydration behaviors. Most of us who are not top-flight athletes don’t have the devices to track our hydration levels regularly. Indeed, aside from fluid analysis, there are only a few useful indicators of a body’s hydration overall.

Thirst is one. But it’s not a real-time indicator, and not especially reliable or exact. When your brain says, “I’m thirsty,” your body has lost almost 2% of its fluid, a condition approaching mild dehydration. To ensure that you’re effectively hydrated, you should drink long before the moment when you actually feel thirsty. Another indicator of hydration is urine, both its amount and color: darker pee and decreased output often signal dehydration, though not in every instance.

These are not exact ways of measuring hydration. But even clinical means of determining hydration have limits, partly because everybody is different. Some of us require more fluids than others. Some people can drink very little and still not be dehydrated. Indeed, there are many complex and individual variables in the hydration equation.

And that complexity only increases when it comes to older people. For example, when an older person is dehydrated, the symptoms could resemble dementia. This can make it difficult to recognize dehydration and address it.

Technology can help.

The good news is that dehydration in the elderly can be prevented using a combination of wearable medical devices and biosensing technology.

There are platforms that can measure a variety of biomarkers continually and noninvasively through a wearable device—in real-time. These platforms work with a photonics sensor that can read changes in the body’s water concentration. The sensor emits different laser wavelengths that pass through the skin to different depths and gauge water spectral features. It observes slight changes in skin components, including collagen, water, and lipids. As the water in the skin ebbs, the level of solutes rises, which alters water absorption.

Such a platform enables the elderly—and caregivers—to know their hydration status to a detailed degree and act to avoid reaching dehydration. The platforms use a “hydration index” that indicates hydration levels and provides suggested actions customized to individuals.

This is a breakthrough. A biomarker-sensing platform makes it possible to measure hydration noninvasively and constantly. It can recommend real-time steps for managing hydration in older people according to their particular needs.

Dehydration in the elderly is a serious problem that deserves more attention. Yes, age-related changes are part of life—but anything we can do to ward off detrimental changes as we age can significantly improve the quality of that life. Making better-informed decisions about hydration can boost our health and well-being far into our advanced years.

About Jennifer Corso (Kukral)

Jennifer Corso (Kukral) is the Upstream Marketing Manager of Physiology at Rockley Photonics, a global leader in photonics-based health monitoring and communications solutions, Rockley Photonics is developing a comprehensive range of photonic integrated circuits and associated modules, sensors, and full-stack solutions.global leader in photonics-based health monitoring and communications solutions.

What You Should Know:

– NeuroSense Therapeutics Ltd., a company developing treatments for severe neurodegenerative diseases, and NeuraLight, a company developing objective and sensitive biomarkers for neurological disorders, today announced a collaboration to advance the science of digital biomarkers in the detection and monitoring of neurological diseases including amyotrophic lateral sclerosis (ALS).

– This agreement marks NeuraLight’s first clinical trial and comes on the heels of NeuraLight’s $25M Series A raise, less than six months after launching the company out of stealth. 

Digitizing Neurological Evaluation and Care

NeuraLight is on a mission to transform the lives of billions of people impacted by neurological disorders by digitizing neurological evaluation and care. Using their AI-driven platform to integrate multiple digital markers to accelerate and improve drug development, monitoring, and precision care for patients with neurological disorders, NeuraLight is revolutionizing patient care.

NeuraLight’s platform, which uses proprietary computer vision and deep learning algorithms to extract over 100 occulometic markers from facial videos captured with a standard webcam, will be used to evaluate ALS patients in a study parallel to NeuroSense’s Phase IIb PARADIGM trial. PARADIGM is a double-blind, placebo-controlled study evaluating the efficacy of NeuroSense’s lead combination drug candidate, PrimeC, in the treatment of ALS. The NeuroSense-NeuraLight collaboration entails sharing and tracking patient data to advance the identification and use of ALS digital biomarkers.  

“There is compelling value in the use of precise biomarkers to diagnose and track the progression of neurodegenerative diseases. We are very pleased to work with the stellar team at NeuraLight who are pioneering the development of digital oculometric biomarkers. This is a great complement to our ongoing collaboration with Massachusetts General Hospital on biological markers of ALS,” said NeuroSense CEO Alon Ben-Noon. “We believe these tools have the potential to enable patient stratification and increase likelihood of success in a pivotal trial. This is a first step in what we envision as a long-term collaboration with NeuraLight in ALS as well as future studies we plan for Alzheimer’s disease and Parkinson’s disease.”

What You Should Know:

– Imagene AI, an emerging leader in the field of AI-based precision medicine for cancer, today announced it raised $21.5 million, comprising $3M in seed funding led by Blumberg Capital and an $18.5M Series A round led by renowned technology-driven cancer medicine investors Larry Ellison, Dr. David Agus, and AI imaging space pioneer Eyal Gura.

– The use of AI-based molecular testing in cancer diagnostics is revolutionizing patient care by offering a new level of personalized, affordable therapeutics that are as efficient as it is scalable.

New Standard for Biomarker Detection

Using only a digitized biopsy image, Imagene’s AI diagnostic technology delivers real-time molecular analysis, setting a new standard by increasing the level of accuracy and reducing the time required for results, from several weeks to just two minutes. Imagene also drives a new approach for a wider scope of treatment response-prediction that encapsulates the uniqueness of each patient, bringing cancer care closer to reaching the full potential of precision medicine.

Imagene’s technology classifies patterns that cannot be seen by the human eye, evolving genomics, proteomics, and spatial insights to better understand the recurrence of specific cancers and their resistance mechanisms; this enables better stratification of patients in clinical trials and the discovery of novel targets for new drugs.

“Though cancer is a complex disease we might never fully understand, AI is bringing us closer to considering all relevant parameters that affect it, allowing a move towards theragnostics – a personal treatment strategy that combines therapeutics with diagnostics,” said Dr. Agus, one of the world’s leading physicians and the co-founder of several pioneering precision medicine companies. “Imagene’s technology can unlock precise and crucial information in real time, changing the way cancer is diagnosed and treated.”

What You Should Know:

- Medidata, a Dassault Systèmes company, today announced that Labcorp, a leading global life sciences company, has selected Medidata’s technology platform to extend their 14-year partnership, the foundation of their initiative to co-develop digital biomarkers and expand the use and functionality of decentralized clinical trials. Labcorp Drug Development has developed its offerings on Medidata technologies, starting with Rave EDC (electronic data capture), Coder and TSDV (targeted source data verification).

– Labcorp is now also using most of the Medidata Clinical Cloud platform, including eCOA (electronic clinical outcome assessment), RTSM (randomization and trial supply management), and Imaging.

What You Should Know:

– VivoSense, an agile end-to-end scientific solutions company developing novel digital endpoints from wearable sensor data raises $25 Million in Series A funding.

– The financing will accelerate the development of novel digital biomarkers and improve digital clinical outcome assessments. VivoSense will also use this financing to expand and refine its informatics platform for data analysis from wearable and connected technologies to deliver validated digital clinical outcome assessments (COAs) for life science research.

Wearable Sensor Biomarkers that Advance Clinical Research

Data captured by wearable sensors will play an increasingly important role in pharma and biotech, and VivoSense is poised to become a leader in developing validated clinical biomarkers and clinical outcome assessments (COAs) for use in registrational studies and regulatory approvals. VivoSense is an agile end-to-end scientific solutions company developing novel digital endpoints from wearable sensor data. True to its name, using its proprietary software, VivoSense “makes sense” of the myriad of biological signals that make up a patient’s physiology. These include physical activity, sleep, temperature, blood glucose levels, respiration, and cardiac function. VivoSense interprets and contextualizes data gathered directly from the patient and makes it available to clinical researchers in pharma and biotechnology. 

“This strategic investment from Debiopharm and the Perceptive Xontogeny Venture (PXV) Fund will allow VivoSense to accelerate the development of real-world digital clinical measures from wearable and remote monitoring technologies,” said Dudley Tabakin, chief executive officer of VivoSense. “Measures that are trusted and valued by all stakeholders are the foundation on which all other innovation in digital health must be based. VivoSense is working to realize the potential of novel measures and technologies in regulatory and medical decision making to leverage real-world data at scale and bring life-saving treatments to the patients who need them most.”

What You Should Know:

– EarliTec Dx, a digital health company developing novel diagnostic and therapeutic products for children with Autism Spectrum Disorder (ASD) and early childhood vulnerabilities, today announced a $19.5 million financing led by Bernie Marcus, with participation from the Georgia Research Alliance (GRA).

– This round of financing will be used to support filing with the U.S. Food and Drug Administration (FDA) for 510K clearance, as well as commercialization of the company’s first product, the EarliPoint® Evaluation for ASD, which received breakthrough status in April 2021.

Why It Matters

Affecting roughly 1 in 44 children, Autism Spectrum Disorder (ASD) is more prevalent than all childhood cancers, juvenile diabetes and heart disease combined. While many parents suspect symptoms of autism before twelve months of age, the median age for diagnosis in the U.S. remains 4-5 years of age. Lack of access to expert clinicians and other disparities can extend the age at which a child is diagnosed. Prolonged identification delays the possibility of treatment in a situation where early intervention is one of the most important factors for improving lifetime outcomes.

The EarliPoint® Evaluation for Autism Spectrum Disorder is an investigational device utilizing Dynamic Quantification of Social-Visual Engagement (DQSVE), to capture moment-by-moment looking behavior imperceptible to the human eye. For a child, it is as simple as watching a video — like scenes of toddlers playing — while the device assesses the individual focal points at a rate of 120 times per second. Each data point is then compared to thousands of discrete measurements within a clinically validated database, to provide a timely, objective and accurate read of potential developmental disabilities.

Completed Clinical Trails

With technology developed by leading researchers at Children’s Healthcare of Atlanta, Emory University School of Medicine and Yale University, the company has completed clinical trials with more than 1,500 children—receiving breakthrough status for the EarliPoint® system in April of last year. This round of financing will be used to support filing with the U.S. Food and Drug Administration (FDA) for 510(k) clearance, commercialization and expansion of EarliTec’s digital biomarkers built on a proprietary multimodal AI platform.

“EarliTec’s ability to measure clinically relevant responses to unscripted social situations is revolutionizing our understanding of the way in which young children with autism learn about their social world,“ said Tom Ressemann, CEO of EarliTec. “With this insight, we can help parents, providers and caregivers, access earlier diagnosis at a time when effective intervention dramatically improves lifetime outcomes.”

What You Should Know:

– GrayMatters Health (GMH), a company set to change the standards of mental health care with biomarker-based therapeutics, beginning with PTSD raises $10 million in Series A funding round led by Otsuka Medical Devices Co., Ltd., bringing total funding to $13.5 million. Additional investors in the Series A round included Joy Ventures, J-Ventures, and J-Impact. Existing GMH investors, Marius Nacht and Joyance Ventures, also participated in the round.

– GMH develops digital self-neuromodulation therapeutics for mental disorders to help patients regain agency over their emotion regulation.

Developing Biomarker-Based PTSD Therapeutics

About 250 million people worldwide live with PTSD, yet treatments are lacking and often lead to many side effects that may last a lifetime.  Prism for PTSD, GMH’s first offering, is under clinical investigation in five sites across the United States and Israel, with a potential to serve as an adjunct for standard of care therapy. Prism helps patients regain agency over their emotion regulation. Prism is a non-invasive adjunct digital therapeutic that utilizes novel neuroscience-based and brain-mechanism-specific biomarkers. GMH is the first to use machine learning technology to create an Electrical-Finger-Print (EFP) of brain-mechanism-specific biomarkers that are utilized in its proprietary treatment of mental disorders, training patients to employ self neuro-modulation techniques using an interactive audio-visual software.

Fusing Electroencephalogram and functional Magnetic Resonance Imaging data, Prism for PTSD produces a continuous, real-time, and accessible amygdala-EFP biomarker. During treatment sessions, an audio-visual interface responds as patients use self-neuromodulation techniques to downregulate their amygdala-EFP biomarker. The company plans to evaluate the clinical efficacy and safety of Prism for additional mental disorder indications including MDD, Attention Deficit Hyperactivity Disorder, General Anxiety Disorder, Obsessive Compulsive Disorder, and Borderline Personality Disorder.

“GrayMatters is introducing the first digital therapeutic device that directly targets and regulates specific brain biomarkers associated with mental disorders, whereas digitizing existing therapy methods focus on mitigating the resulting symptoms and behaviors,” said Oded Kraft, GrayMatters Health Co-Founder and CEO. “This funding round will help GrayMatters Health complete its clinical investigation, obtain clearance from regulatory authorities, and launch Prism for PTSD in the United States. It also supports our collaboration with McLean Hospital, the largest psychiatric affiliate of Harvard Medical School and a member of Mass General Brigham. Together we plan to conduct a clinical investigation to determine Prism’s efficacy and safety as an adjunct treatment for Major Depressive Disorder (MDD) with anhedonia.”

What You Should Know:

– Medidata, a Dassault Systèmes company, today announced a first-of-its-kind partnership with Labcorp using the Medidata Sensor Cloud to introduce a new model to advance the use of medical-grade sensors in clinical trials and accelerate biomarker discovery.

– As part of the partnership, Medidata will receive and process medical-grade sensor data within drug, vaccine and device trials across Labcorp Drug Development’s clinical trial portfolio, enhancing their decentralized clinical trial (DCT) offerings.

– Using Medidata Sensor Cloud, Labcorp will enhance its decentralized clinical trial offerings through the collection and processing of medical-grade sensor data within drug, vaccine and device trials in an effort to accelerate and improve patient outcomes. In addition, Labcorp and Medidata will co-develop digital biomarkers across a broad array of medical devices and therapeutic areas. The goal of this is to build a library of digital biomarkers that can be used to advance therapeutic research and create new, digital diagnostics.

Medidata Sensor Cloud Background

Sensor Cloud is a transformative platform for managing a broad range of sensor and digital health technology data and establishing interoperability with other clinical data sources. Launched earlier this year, Sensor Cloud integrates seamlessly with the Medidata Clinical Cloud and supports remote, continuous patient data collection from both Medidata and third-party, medical-grade sensors. This innovation provides a more comprehensive view of the patient experience through cutting-edge data ingestion, data standardization across all sensor types, and deep analytical capabilities that will ultimately lead to new digital biomarker discovery and digital endpoint deployment.

In addition, Labcorp and Medidata will use Sensor Cloud to co-develop digital biomarkers across a broad array of medical devices and therapeutic areas. The goal of this first-of-its-kind collaboration is to build a library of digital biomarkers that can be used to advance therapeutic research and create new, digital diagnostics. The first project will be an at-home version of the Six Minute Walk Test (6MWT), which is widely used in clinics to measure functional capacity in patients with heart failure, pulmonary conditions, physical function disorders and rare diseases.

“Sensor Cloud solves key technical, operational, and analytical challenges that have historically stifled the widespread usage of medical devices in clinical research,” said Ben Schlatka, vice president of digital biomarker solutions at Medidata. “This technology is urgently needed, with device usage dramatically escalating as patients, sponsors and sites demand greater flexibility during clinical trials. Combining the power of Sensor Cloud with Labcorp’s innovative approach to clinical research and its scale in clinical diagnostics will transform how patient data are collected, managed, analyzed and leveraged—driving faster, more effective drug development and overall better health outcomes.”

What You Should Know:

– Mayo Clinic announced a collaboration with Vocalis Health to to research and develop new voice-based tools for screening, detecting and monitoring patient health, beginning with a study to identify vocal biomarkers to detect pulmonary hypertension (PH).

– The clinical validation study will utilize Vocalis Health’s proprietary software, which can operate on any connected voice platform (mobile, computer, tablet, etc.) to analyze patients’ health based on voice recordings.

– Following this initial phase, researchers will work to identify vocal biomarkers targeting additional diseases, symptoms and conditions.

Mayo Clinic and Vocalis Health, Inc., a company pioneering AI-based vocal biomarkers for use in healthcare, today announced a collaboration to research and develop new voice-based tools for screening, detecting and monitoring patient health. The collaboration will begin with a study to identify vocal biomarkers for pulmonary hypertension (PH) which could help physicians detect and treat PH in their patients.

Impact of Pulmonary Hypertension

Pulmonary hypertension is a severe condition causing high blood pressure in the lungs, but as the symptoms are similar to other heart and lung conditions, it is often not detected in routine physical exams. While traditional blood tests can sometimes detect pulmonary hypertension, it frequently goes undiagnosed. This strategic collaboration aims to provide an alternative and highly scalable method to check patients for PH, using only a recording of the patient’s voice, to understand their health and the progression of the disease. 

Study Establishes Relationship Between Certain Vocal Biomarkers & Pulmonary Hypertension

In a previous trial with Vocalis Health, the Mayo research team established a relationship between certain vocal characteristics and PH. In this new collaboration, Mayo will conduct a prospective clinical validation study to further develop PH vocal biomarkers. The clinical validation study will utilize Vocalis Health’s proprietary software, which can operate on any connected voice platform (mobile, computer, tablet, etc.) to analyze patients’ health based on voice recordings. Following this initial phase, researchers will work to identify vocal biomarkers targeting additional diseases, symptoms and conditions.

Vocalis Health Background

Vocalis Health is an AI healthtech company pioneering the development of vocal biomarkers – where health-related information is derived from analysis of people’s voice recordings – to screen, detect, monitor and predict health symptoms, conditions and diseases.  Vocalis Health is currently focused on screening users for COVID-19 and on monitoring patients with chronic diseases such as COPD.

“We have seen the clinical benefits of voice analysis for patient screening throughout the COVID-19 pandemic, and this collaboration presents an opportunity for us to continue broadening our research, beginning with pulmonary hypertension,” said Tal Wenderow, CEO of Vocalis Health. “Voice analysis has the potential to help physicians make more informed decisions about their patients in a non-invasive, cost-effective manner. We believe this technology could have important clinical implications for telemedicine and remote patient monitoring in the very near future. We are excited to work with Mayo Clinic and have already started planning clinical trials for additional indications.”

What You Should Know:

– Clinical trials technology company Medidata has acquired the digital biomarker business of MC10.

– MC10’s offerings will bring novel clinical analytics and biosensor capabilities to Medidata’s existing technology solutions, enhancing Medidata’s capabilities to integrate data from wearable sensors – including clinical grade metrics – in clinical trials.

– With this acquisition, Medidata’s integrated offering will help provide life sciences companies and device developers with greater understanding of diseases, transformational therapies, and novel endpoints.

Medidata, a Dassault Systèmes company, the global leader in creating end-to-end solutions to support the entire clinical development process, acquired the digital biomarker business of MC10. MC10’s offerings will bring novel clinical analytics and biosensor capabilities to Medidata’s existing Patient Cloud solutions in ePRO (patient-reported outcomes), eCOA (clinical outcome assessments), and biomarker discovery. This will enhance Medidata’s capabilities of integrating data from wearable sensors – including clinical grade metrics – to help customers successfully virtualize clinical trials.

MC10 Background

MC10 is a Lexington, MA-based privately held company focused on improving human health through digital solutions. The company combines conformal BioStamp sensors with clinical analytics to unlock novel insights from physiological data collected from the home or in clinical settings. The company flagship product, BioStamp nPoint, is intended for the clinical research community.

Why It Matters

Remote, patient-centered technologies have become an essential part of clinical research, especially in the age of COVID-19; the physical restrictions placed on patients and clinical sites caused by the pandemic can interfere with launching a clinical study and carrying it to completion. Wearable sensors are used in about 15 percent of studies, and the use of sensors is expected to grow to approximately 70 percent by 2025.* 

Medidata leads the industry in building and integrating new technologies to revolutionize clinical research in pursuit of patient-centric therapy development. MC10’s focus on clinical-grade data capture and novel digital biomarker development represents an important next chapter – advancing the understanding of disease progression and treatment effect in the home. 

“Medidata is excited to add the pioneering work at MC10 to our ongoing efforts in building a new platform for ingestion and analytics across a wide array of mobile sensors,” said Anthony Costello, senior vice president, Mobile Health, Medidata. “Incorporating remote biometric data capture and analysis that includes the MC10 nPoint Biostamp, alongside other leading mobile devices, will further strengthen the Medidata platform and help propel the digital transformation of life sciences.”

Acquisition Builds Integrated Offering

An integrated Medidata offering will provide research companies and device developers new and innovative ways to collect, normalize, and analyze data in pursuit of new therapy development. This enhanced capability will also create a closer connection between patients and the ecosystem of trailblazing researchers, practitioners, and life science companies committed to deepening a shared understanding of the disease, transformational therapies, and novel endpoints.

“Medidata is an exceptional fit for MC10. Our combined expertise will help customers and partners take a more data-driven approach to bringing targeted therapies to patients,” said Ben Schlatka, co-founder and CEO, MC10. “We are looking forward to moving ahead together, accelerating the development and deployment of new innovative offerings for our customers and ultimately transforming therapy development to improve the lives of patients.”