Mental Health Startup Uses Voice ‘Biomarkers’ To Detect Signs Of Depression And Anxiety

Young female character having a panic attack, an imaginary monster shadow silhouette, mental health issues, psychology

The quick brown fox jumps over the lazy dog,” Rima Seiilova-Olson says slowly and emphatically over Zoom.

The simple sentence holds enormous value for mental health care, she explains, smiling as if to acknowledge that it might be less than obvious how a silly phrase could be so meaningful to a computer programmer and leader of an artificial intelligence startup.

The short saying contains every letter of the alphabet and phoneme in the English language, says Seiilova-Olson, an immigrant from Kazakhstan who is cofounder and chief scientist of Kintsugi Mindful Wellness. Kintsugi believes these sounds offer invaluable insight that can help mental health providers better support people with depression and anxiety.

The Bay Area-based company is building AI software that analyzes short clips of speech to detect depression and anxiety. This so-called voice biomarker software is being integrated into clinical call centers, telehealth services and remote monitoring apps to screen and triage patients reaching out for support, helping providers more quickly and easily assess their needs and respond.

“There’s just not a lot of visibility as to who is severely depressed or anxious.”

Kintsugi CEO and co-founder Grace Chang

Seiilova-Olson, 36, first met co-founder and CEO Grace Chang, 40, a Taiwanese immigrant now based in Berkeley, in 2019 at an open AI hackathon in San Francisco. Surprised to cross paths at a male-dominated event, the women began comparing notes about their respective personal challenges trying to access mental health care:

Seiilova-Olson had struggled to secure a therapist during postpartum depression with her first child, and when Chang had needed her own support, she said it had taken months for anyone from Kaiser to call her back.

“Living in the Bay Area, you can push a button and a car can come to you or food can come to you,” Chang says. “But this was really a challenge.” As engineers, they viewed the dilemma differently than clinicians might.

“We saw this as an infrastructure problem, where you have so many people trying to jam through that front door,” Chang explains. “But there’s just not a lot of visibility as to who is severely depressed or anxious, who is low-to-moderate. And if we could provide this information to those frontline practitioners, then we’d maybe have an opportunity to greatly alleviate that bottleneck.”

Kintsugi was born out of that idea in 2019. It sits in a competitive space of health tech startups like Ellipsis Health and Winter Light Labs that are using voice biomarkers to detect mental health or cognitive issues, built on research showing that certain linguistic patterns and characteristics of a person’s voice can be correlated with psychiatric or neurological conditions.

Kintsugi last year raised $8 million in seed funding led by Acrew Capital, and in February, announced it had closed a $20 million Series A round led by Insight Partners, which valued the company at nearly $85 million, according to PitchBook.

In-person mental health facilities typically use questionnaires to gauge the severity of patients’ anxiety or depression, measures known as PHQ-9 and GAD-7 scores. But during telehealth visits or phone consults — where face-to-face interaction is lost, making it harder to pick up on symptoms — Kintsugi’s technology helps to fill that gap.

Nicha Cumberbatch, assistant director of public health at Spora Health, a provider focused on health equity and people of color, uses Kintsugi’s software to assess women in its all-virtual, doula-led maternal health program, Spora Mommas.

The voice analysis tool, which Spora began using for patient consultations a few weeks ago, has helped Cumberbatch identify women who are, or may be at risk of, experiencing anxiety and depression before, during or after their pregnancies. When a patient starts speaking to a Spora clinician or doula on Zoom, Kintsugi’s AI begins listening to and analyzing her voice.

After processing 20 seconds of speech, the AI will then spit out the patient’s PHQ-9 and GAD-7. The employee can then use that mental health score to decide what additional testing may be needed and how best to advise or direct the patient to resources — like a psychiatrist, cognitive behavioral therapist or obstetrician.

Cumberbatch says Kintsugi’s technology is allowing her to “​​keep a more watchful eye” on her patients “and then move forward with proactive recommendations around mitigating their symptoms.” And while it’s not meant to replace clinicians or formal medical evaluations, she adds, it can be used as a screening tool to “allow us to have a more well-rounded, 360-view of the patient when we don’t have them in front of our face.”

“That technology… [allows] us to have a more well-rounded, 360-view of the patient when we don’t have them in front of our face.”

Nicha Cumberbatch, assistant director of public health at Spora Health

Dr. ​​Jaskanwal Deep Singh Sara, a Mayo Clinic cardiologist who has collaborated with Ellipsis and led research on potential uses of voice biomarkers for cardiology, cautions that while the technology is promising for health care, the field has a long way to go to ensure that it’s accurate, safe and beneficial for patients and clinicians alike.

“It’s not ready for primetime by any stretch of the imagination yet,” Dr. Sara says. Studies in psychiatry, neurology, cardiology and other areas have shown an association between voice biomarkers and various conditions or diseases, but they haven’t shown how this relationship can be used to improve clinical outcomes, he says.

Such research is “not the same as saying, ‘How can we instrumentalize it in clinical practice, and how feasible is it? How effective is it in gauging an individual’s medical trajectory?’” he explains. “If it doesn’t provide any benefits in terms of how we manage them, then the question is: why would you do it?”

He says addressing those questions is “one of many next steps that we have to undertake on this” and that larger clinical trials are needed to answer them. “If it makes health care delivery cheaper or more efficient, or if it improves outcomes for patients, then that’s great,” he adds. “But I think we need to demonstrate that first with clinical trials, and that hasn’t been done.”

To address these issues and validate its software, Kintsugi is conducting clinical studies, including with the University of Arkansas for Medical Sciences, and the National Science Foundation has awarded Kintsugi multiple grants to ramp up its research. The company is also pursuing FDA “de novo” clearance and continuing to build its own dataset to improve its machine learning models.

(Data and insights from Kintsugi’s voice journaling app, as well as conversations with call centers or telehealth providers and clinical collaborations with various hospitals, all become part of an enormous dataset that feeds Kintsugi’s AI.) Seiilova-Olson says this self-generated, unfettered proprietary dataset is what sets Kintsugi apart in the AI health care space — where many technologies are reliant on outside data from electronic health records.

That collection of troves of data on individuals’ speech can be concerning — particularly in the mental health and wellness space, which is widely considered a regulatory Wild West. (These products and services are often not subject to the same laws and stringent standards that govern how licensed clinicians provide formal medical care to patients.)

But Kintsugi’s founders say that patient privacy is protected because what matters for its technology is not what people are saying, but how they are saying it. Patients are also asked for their consent to be recorded and care is not affected by their decision to opt in or opt out, according to the founders.

Kintsugi says it has served an estimated 34,000 patients. The company is currently working with a large health system with 90 hospitals and clinics across 22 states, and they are active in a care management call center that services roughly 20 million calls per year. It is also partnering with Pegasystems, which offers customer service tools for health care and other industries, to help payers and providers handle inbound calls.

Chang says other customers include Fortune 10 enterprise payers, pharmaceutical organizations and digital health applications focused on remote patient monitoring, but that she could not yet share their names. Kintsugi’s clinical partners include Children’s Hospital Colorado, Joe DiMaggio Children’s Hospital in Florida, Chelsea and Westminster Hospital in London and SJD Barcelona Children’s Hospital in Spain, Chang said.

Prentice Tom, Kintsugi’s chief medical officer, adds that it’s working with the University of Arkansas to explore how the tool can be used to possibly identify patients with suicidal ideation, or increased or severe suicide risk, as well as with Loma Linda University, to look at how the technology can be used to spot burnout amongst clinicians.

The team is also looking for ways to expand availability and uses for younger and elderly patients, as well as for maternal and postpartum populations. And beyond patients themselves, it’s perhaps nurses who are benefiting most from Kintsugi’s work, according to the founding team: having a triage tool that helps reduce administrative work or the time spent asking generic questions enables nurses to more seamlessly move patients in their journey.

But Tom, a Harvard-trained emergency medicine physician and former faculty member at Stanford University’s Department of Emergency Medicine, says Kintsugi is now doing far more than addressing infrastructure issues alone. It’s democratizing access to mental health care, Tom said, moving away from a physician-centric paradigm that caters more to people with significant enough depression that they require medical evaluation.

“This tool actually creates a view of mental health in terms of mental wellness,” Tom said, “where everyone has the opportunity to understand where they sit on the spectrum and that actually stratifies treatment options well beyond the current infrastructure.”

I’m a Senior Writer at Forbes covering the intersection of technology and society. Before joining Forbes, I spent three years as a tech reporter at Politico, where I covered

Source: Mental Health Startup Uses Voice ‘Biomarkers’ To Detect Signs Of Depression And Anxiety

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Scientists are Studying Blood Tests For Dementia

As pharmaceutical companies spend hundreds of millions of dollars on a potential treatment for Alzheimer’s disease, other researchers are focusing on a more elemental question. How can you tell whether a family member or loved one has Alzheimer’s or another form of dementia?

These researchers say a new generation of blood tests could offer an easier and accurate way to detect signs of Alzheimer’s, a disease that afflicts an estimated 6.5 million Americans. New research found one blood test can detect hallmarks of the disease in older adults with memory problems. It is among more than a half dozen blood tests being developed and tested to detect early stages of Alzheimer’s disease.

Experts say the tests are important because they would be easier, cheaper and available to more people than brain scans or spinal taps now used to detect biological hallmarks of the disease.

Developers of blood tests say the immediate payoff would be testing older adults with signs of memory loss as well as quickly screening large numbers of people necessary to test new drugs that aim to slow or halt Alzheimer’s disease. Eventually, the tests might be useful in detecting the earliest signs of disease, informing individuals of their risk years before memory and thinking problems take root.

Blood tests represent “a very early start to a new era of diagnosis for Alzheimer’s disease,” said Stephen Salloway, a professor of neurology and psychiatry at Brown University who directs a memory and aging program at Butler Hospital in Providence, Rhode Island. “I see them as being transformative for Alzheimer’s, because once we validate them a little bit further, and hopefully get coverage for them, we can use them both to screen for clinical trials and to screen for treatment.”

Diagnosing the disease is time-consuming and inaccessible to those who live far away from memory clinics or other specialists. Doctors might quiz a patient or family members about habits, changes in behavior or personality. Specialists conduct memory and cognitive tests and rule out other potential causes such as depression. Brain scans and spinal taps confirm biological signs of the disease.

One blood test, called the PrecivityAD test, which uses a technology called mass spectrometry, measures amyloid proteins and genetic risk for the disease. In two studies published April 21 in Journal of the American Medical Association Open, the test accurately detected the protein amyloid in 81% of samples when compared with a brain scan.

Amyloid accumulates and forms clumps in the brains of Alzheimer’s disease patients. Researchers and drug companies have spent hundreds of million of dollars over the past two decades on the theory that drugs clearing amyloid from the brain could slow memory decline, but those drugs have not proven to halt Alzheimer’s disease.

Other drug studies are now underway to administer amyloid-targeting drugs even earlier, before memory and thinking problems emerge. C2N Diagnostics CEO Joel Braunstein said the peer-reviewed study is an important step for doctors who want to see more evidence before recommending his company’s test to patients with memory and cognitive problems.

“Clinicians like to see evidence that a test works,” Braunstein said. “This was an important step forward because of the transparency of the scientific findings.”

The test, which has been available since 2020, is now mostly used to accelerate research for new drugs being studied to slow cognitive decline and memory loss in people with Alzheimer’s disease or other forms of dementia. Braunstein believes more doctors will be willing to recommend the test as they grow comfortable from findings in the studies.

Blood tests promise quicker, cheaper diagnosis

Scans and spinal taps now used can be invasive and don’t work for all patients. For example, people who are on blood-thinning medication might not be able to get a spinal tap, Salloway said. In such cases, a validated blood test would be suitable replacement.

Blood tests also might be more affordable than positron emission tomography, or PET scans, which cost consumers $3,000 out of pocket, according to the Alzheimer’s Association. Hospitals charge for administering a PET scan, which includes special chemical tracers to reveal the amyloid. Consumers also can expect a bill from an imaging specialist who interprets the results to verify whether a patient has amyloid.

The PrecivityAD test, which is not yet covered by Medicare or private insurers, costs $1,250. The company offers financial assistance for eligible consumers, Braunstein said, while it is “making progress” in efforts to get Medicare and private insurers to pay for the test.

The company is allowed to market the test under Food and Drug Administration rules because it’s performed at the company’s lab, which is certified under the Clinical Laboratory Improvement Amendments, the federal laboratory law known as CLIA. Doctors or testing sites ship samples to the lab and the company completes the test within 10 days, Braunstein said.

Braunstein said the company’s lab has the capacity to handle tests performed within the United States and Canada. As the company seeks to offer the test overseas, it probably will partner with other labs that can perform the intricate measurements the test requires.

Another blood test developed by Eli Lilly detected signs of Alzheimer’s disease 20 years before cognitive problems were expected in a group of people who carry a rare genetic mutation, according to a study published in 2020 in JAMA. The p-tau217 test measured the tau protein on more than 1,400 people already enrolled in dementia studies in Sweden, Arizona and Colombia.

Eli Lilly used the test during a 257-patient Phase 2 study of its Alzheimer’s drug called donanemab. The drugmaker also will use the test to screen people for a prevention trial to test donanemab in at-risk patients who have not yet exhibited memory and thinking problems. Lilly plans to send mobile units to communities and use the test to screen people, which would expand the company’s efforts to recruit patients from diverse populations, a Lilly spokeswoman said.

Quest Diagnostics, a national lab company, launched a new blood test in March that measures two amyloid variants, a Quest spokeswoman said.

Advocacy organizations would like to see tests that are simple, inexpensive and accessible to doctors and their patients, said Heather Snyder, vice president of medical and scientific relations at the Alzheimer’s Association.

“We ultimately want to be at a place where we can identify an individual at the earliest possible point who may be at the greatest risk and may have initial changes associated with the disease,” Snyder said.

She said it’s important for the field to have “a toolbox of potential interventions” such as medications or lifestyle changes “that would allow us to stop or slow the progression of the underlying biology at that time.”

In 2021, the Food and Drug Administration approved Biogen’s Aduhelm, a $28,000-a-year drug that yielded mixed results in clinical trials, even though the agency’s own experts suggested the agency reject the application. The agency that oversees Medicare decided to pay for the drug only in clinical trials.

Aduhelm is part of class of Alzheimer’s drugs known as monoclonal antibodies, several of which could soon land before FDA decision-makers. Lilly expects to submit donanemab, a monoclonal antibody, for approval later this year. Roche’s Genentech has studied two Alzheimer’s drugs, gantenerumab and crenezumab, in late-stage clinical trials.

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Source: Scientists are studying blood tests for dementia: ‘A new era of diagnosis for Alzheimer’s disease’

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FDA Committee Says It’s Safe For All Adults Who Got J&J’s COVID-19 Vaccine To Get a Booster

The Food and Drug Administration should authorize a second “booster” dose of Johnson & Johnson’s JNJ, +0.74% COVID-19 vaccine for adults who were initially vaccinated with this vaccine, according to a group of scientists and clinicians that advises the regulator.

The FDA’s Vaccines and Related Biological Products Advisory Committee voted 19-0 that allowing adults who were initially vaccinated with the J&J shot to get a booster is safe and effective. Their recommendation is based on giving a booster to those 18 years old and older at least two months after they got their first shot.

“This does look more like a two-dose vaccine,” Dr. Michael Nelson, a professor of medicine UVA Health and the UVA School of Medicine and a temporary voting member of the FDA committee.

One difference with this booster recommendation is that the group of people who would qualify for the J&J booster can get it two months after getting their first dose, compared with six months after the primary series of shots for the mRNA vaccines developed by Moderna Inc. MRNA, -2.31% and BioNTech SE BNTX, -1.06% /Pfizer Inc. PFE, -0.43%.

If the FDA follows the advice of the committee, which it is not required to do but often does, it means that all three COVID-19 vaccines that are available in the U.S. have authorized boosters, with the caveat that there are restrictions in place on who can get a mRNA booster.

The mRNA boosters are reserved at this time for people older than 65 years old, adults who are at high risk of severe disease, and those who face higher exposure to the virus because of their jobs.

About 15 million people in the U.S. have received the J&J’s adenovirus-based COVID-19 vaccine. J&J’s stock is up 2.6% so far this year, while the broader S&P 500 SPX, +0.75% has gained 18.1%.

By: Jaimy Lee

Jaimy Lee is a health-care reporter for MarketWatch. She is based in New York.

Source: FDA committee says it’s safe for all adults who got J&J’s COVID-19 vaccine to get a booster – MarketWatch

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Critics:

The Janssen COVID‑19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized by FDA through an Emergency Use Authorization (EUA) for active immunization to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older.

The emergency use of this product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the medical product under Section 564(b)(1) of the FD&C Act, unless the declaration is terminated or authorization revoked sooner.

Healthcare professionals should be alert to the signs and symptoms of thrombosis with thrombocytopenia in individuals who receive the Janssen COVID-19 Vaccine. In individuals with suspected thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine, the use of heparin may be harmful and alternative treatments may be needed.

Consultation with hematology specialists is strongly recommended. The American Society of Hematology has published considerations relevant to the diagnosis and treatment of thrombosis with thrombocytopenia following administration of the Janssen COVID-19 Vaccine (https://www.hematology.org/covid-19/vaccine-induced-immune-thrombotic-thrombocytopenia).

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