SOLVD Health
FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder

FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder

Dec 19, 2023

News Release

FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder

The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health

December 19, 2023 – Today, the U.S. Food and Drug Administration approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder (OUD). As part of a clinical evaluation, the AutoGenomics, Inc. AvertD test is intended to be used prior to first exposure to oral opioid pain medications in patients being considered for a 4-30 day prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure.

The AvertD test, a prescription-use only genetic laboratory test for patients 18 years and older, is to be used only with patients who consent to the test and have no prior use of oral opioid analgesics. The test is administered by a health care provider by swabbing the cheek of a patient to collect a DNA sample that will be used to determine if a patient has a combination of genetic variants that may be associated with an elevated risk of developing OUD. This information should be used as part of a complete clinical evaluation and risk assessment; it should not be used alone to make treatment decisions. The test is not intended to be used in patients being treated for chronic pain. AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions.

In August 2022, the FDA introduced the FDA Overdose Prevention Framework. Through the Framework, the agency has taken steps to address the drug overdose crisis and substance use disorder, including the approvals of the first nonprescription naloxone nasal spray product and the first generic nonprescription naloxone nasal spray product in March 2023 and July 2023, respectively. The FDA also published draft guidance on Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder in July 2023.

As part of the approval order, AutoGenomic, Inc. must provide training to health care providers to help ensure appropriate use of the test and conduct a large post-market study assessing device performance in patients, regularly reporting progress made toward completion of that study to the FDA.

An earlier version of the AvertD test was the focus of an October 2022 advisory committee meeting, in which a panel discussed data and information related to the test, provided recommendations and voted on the De Novo request for the test. Following the advisory committee meeting, FDA worked with AutoGenomics, Inc. as it modified its test. AutoGenomics subsequently submitted a Premarket Approval application (PMA) for the modified test. The advisory committee’s feedback helped inform the FDA’s evaluation of the test and today’s decision, including the conditions for approval.

The primary risks associated with AvertD, as with any in vitro diagnostic test, are false negative and false positive results. A false negative result could lead to a false sense of security for a patient who is at increased risk of OUD, and/or a health care provider considering prescribing an opioid analgesic which could result in a provider prescribing an opioid analgesic to a patient to whom they would otherwise not do so. The risks of a false positive result (i.e., incorrectly identifying an individual as having a higher risk of OUD) include inadequate pain management due to avoidance of opioids, which may prevent patients from receiving optimal medical care to treat their acute pain. The risks of false negative and false positive results can be mitigated, in part, through accurate, transparent product labeling and a health care provider training program. It is critical that users of the test (health care providers and patients) understand how to interpret the test result and use it not in isolation, but as part of a comprehensive clinical evaluation and risk assessment.

The FDA recognizes that in premarket decision-making for devices, there generally exists some uncertainty around benefits and risks. Given the totality of available evidence and the urgent need for medical devices that can make a positive impact on the overdose crisis, and specifically devices that can help assess the risk of developing OUD, the FDA determined that there is a reasonable assurance of AvertD’s safety and effectiveness, taking into consideration available alternatives, patients’ perspectives, the public health need and the ability to address uncertainty through the collection of post-market data. The PMA incorporates very precise conditions of approval, including mandating a post-approval study and the monitoring of test performance.

The opioid crisis, one of the most profound public health issues facing the United States, calls for innovative measures to prevent, diagnose and treat opioid use disorder, including to assess the risk of developing the disorder. The FDA also has previously granted marketing authorization to several medical devices intended to help individuals reduce the need to use opioid analgesics. The FDA will continue to offer support and expertise to help with the development of medical devices that address the evolving needs of the overdose crisis. This approval represents another step forward in the FDA’s efforts to prevent new cases of OUD, support the treatment of those with the disorder and decrease the misuse of opioid analgesics.

About SOLVD Health

SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, we are enabling individuals and their providers to make better decisions about their health and the health of their families. We accomplish this by translating complex biological signals into actionable patient data that can point the way to better health. To learn more about us, our solutions, and our career opportunities, visit us at www.solvdhealth.com.

Media Contact:
 Public Relations pr@solvdhealth.com 

SOLVD Health CEO Named Clinical Scientist of the Year by the Association of Clinical Scientists

SOLVD Health CEO Named Clinical Scientist of the Year by the Association of Clinical Scientists

Jun 1, 2021

News Release

SOLVD Health CEO Named Clinical Scientist of the Year by the Association of Clinical Scientists

Dr. Keri Donaldson was recognized by his peers for his outstanding contributions to clinical science in research, teaching, and service.

CARLSBAD, Calif., June 1, 2021 – Keri Donaldson, MD, the CEO and founder of SOLVD Health, a privately held company focused on preventing disease by making actionable and contextual health information accessible to everyone, was recently named Clinical Scientist of the Year by the Association of Clinical Scientists (ACS).

Each year, the Awards Committee selects a Fellow of the Association to receive the annual Sunderman Award, which is named in honor of Dr. F.W. Sunderman, Sr., the Association’s founder. The recipient is selected by their peers for making outstanding contributions to clinical science in research, teaching, and service, and is designated the Clinical Scientist of the Year.

Dr. Donaldson is the current president of ACS and has dedicated his medical career to improving people’s lives through advancements in pathology, genomics, and diagnostics. Prior to founding SOLVD Health, he directed numerous clinical laboratories and has held key positions within respected institutions including University of Pennsylvania, Penn State Health, and Temple University. In addition, he is active in numerous national committees and professional societies focused on improving diagnostic testing and patient care. He holds an MD from Temple University School of Medicine and a Master of Science in Clinical Epidemiology (MSCE) from the University of Pennsylvania School of Medicine.

ACS was formed in 1949 to promote education and research in clinical science. Overarching goals of the Association include improving laboratory testing and encouraging cooperation among health professionals in the application of scientific methods in clinical practice and research.

About SOLVD Health

SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, we are enabling individuals and their providers to make better decisions about their health and the health of their families. We accomplish this by translating complex biological signals into actionable patient data that can point the way to better health. To learn more about us, our solutions, and our career opportunities, visit us at www.solvdhealth.com.

Media Contact:
Janelle Drumwright; pr@solvdhealth.com 

 

What is Pharmacogenomics (PGx) Testing?

What is Pharmacogenomics (PGx) Testing?

May 10, 2021

Our understanding of human DNA and how our genes impact our health has grown exponentially over the past few decades. From these discoveries, a key area of research has emerged known as pharmacogenomics—the study of how genes affect the body’s response to certain medications.

Just as your genes determine the basic truths of your biology—things like your height and eye and hair color—genes also determine how your body reacts to certain medications. No medication works the same for everyone; in fact, results can vary widely.

Although more than 5 billion prescriptions are filled each year1, response rates for many drugs are only 50-75%2. It is estimated that ineffective medications produce an additional $528 billion in healthcare costs each year.3

Pharmacogenomics (PGx) testing looks at specific genes that affect the body’s response to certain medications. This information can be used by your healthcare provider to:

  • Determine which medications are most and least likely to be effective for you
  • Determine what the best dosage might be for you
  • Predict whether you will have a serious side effect from a medication

Research has shown that >90% of patients possess clinically actionable genetic variants that affect their drug response.4,5

How Genes Predict Drug Effectiveness

Each of us has a system of proteins that influence how we metabolize, transport, and respond to medications in our bodies. Using genetics to understand these proteins makes it possible to predict how effective a medication will be.

Studies have shown that a family of liver enzymes called Cytochrome P450 (CYP450), which is largely responsible for neutralizing impurities in the blood, conduct about 90% of drug metabolization.6

Your body sees medications as impurities. As soon as a medication hits your bloodstream, your CYP450 begins breaking it down. How much of a given CYP450 enzyme your body produces is determined by your genes. In general, if you have a lot, it will clean medications out of your bloodstream quickly. If you have only a little, the medication will build up over time.

Typically, medication dosages are set for people with an average level of CYP450 enzymes. PGx testing helps your healthcare provider determine if your dose needs to be increased or decreased and whether a medication that works for most people might be ineffective or even dangerous for you.

Scientists have classified CYP450 enzymes into three primary categories:

  1. Rapid metabolizer: A rapid metabolizer breaks down medications very quickly, which means your body may not be exposed to enough of it and the medication won’t be as effective.
  2. Slow metabolizer: A slow metabolizer breaks down medications very slowly. As a result, medications metabolized by these enzymes might remain in the body longer, which could lead to adverse side effects.
  3. Extensive metabolizer: An extensive metabolizer breaks down medications at what is considered a ‘normal’ rate. Ideally, providers should consider choosing medications that fall in this category.

Benefits of Pharmacogenomics Testing

One of the areas PGx testing is revolutionizing is in mental health treatment. Anxiety disorders are one of the most common psychiatric disorders in the U.S. Approximately 40 million American adults have some form of anxiety disorder.7

The good news is that there are many different psychiatric medications available to help patients with anxiety. The bad news is that it can be challenging to find the right medication and dosage that both maximize effectiveness and minimize side effects and adverse drug reactions.

As a result, psychiatric medication is often prescribed on a trial-and-error basis, with healthcare providers monitoring the patient’s response and then adjusting medications or doses as needed. This process can be frustrating, time-consuming, expensive, and can potentially make the patient’s condition worse before the right combination is found. In fact, 50% of depression patients do not respond to the first medication they try.8

Instead of going through the painstaking process of trial and error, pharmacogenomics testing can help providers select medications and dosages most likely to be effective from the start.

One study showed that on average, patients with mood/anxiety disorders using PGx testing have a ~$2,000 reduction in health care costs, 40% reduction in ER visits, and a 60% reduction in hospitalizations.9 In a separate study, individuals who received PGx-guided decision support tools therapy were 1.71 times more likely to achieve symptom remission relative to individuals who received treatment as usual.10

LifeKit® PreScript from SOLVD Health

SOLVD Health is driving innovation and making health possible by helping healthcare providers use genetic testing to identify the best possible treatment paths for their patients. SOLVD Health’s LifeKit® PreScript is a genetic test that helps providers, based on their patient’s DNA, identify which medications are most likely to be effective and which should be avoided.

Using a simple cheek swab sample, LifeKit PreScript analyzes 14 genetic variants that impact how a person’s body metabolizes medication. Providers receive a detailed report that indicates how an individual will respond to the medications they are currently prescribed, as well as any medications being considered for future use, to help support more informed decision-making about drug selection. The result is a treatment designed specifically for you.

References:

1IMS Institute for Healthcare Informatics
2Spear BB, Heath-Chiozzi M, Hu J: Clinical application of pharmacogenetics. Trends Mol. Med.7, 201–204 (2001).
3Watanabe, J. H., et al. Cost of Prescription Drug–Related Morbidity and Mortality. Annals of Pharmacotherapy. 2018; 52(9), 829–837.
4Van Driest, SL, et. al., Clin Pharmacol Ther. 2014; 95(4): 423–431.
5Yuan, J. et. al., Jmol Diag. 2016; 18(3): 438-445.
6Lynch, T., & Price, A. (2007). The Effect of Cytochrome P450 Metabolism on Drug Response, Interactions, and Adverse Effects. American Family Physician, 391–396. https://www.aafp.org/afp/2007/0801/p391.html
7Anxiety and Depression Association of America. (n.d.). Facts & Statistics. Anxiety and Depression Association of America, ADAA.
8Perlis et al. Pharmacogenetic Testing Among Patients With Mood and Anxiety Disorders Is Associated With Decreased Utilization and Cost: A Propensity-Score Matched Study. Depression and Anxiety. 2018; 35(10), 946–952.
9Bousman et al. Pharmacogenetic tests and depressive symptom remission: a meta-analysis of randomized controlled trials; Dec 2018 https://doi.org/10.2217/pgs-2018-0142
10Trivedi MH, Rush AJ, Wisniewski SR, et al. Evaluation of outcomes with citalopram for depression using measurement-based care in STAR*D: implications for clinical practice. Am J Psychiatry. 2006;163(1):28-40.

SOLVD Health Prepares to Launch Clinical Study of Non-Invasive Colorectal Cancer Screening Test

SOLVD Health Prepares to Launch Clinical Study of Non-Invasive Colorectal Cancer Screening Test

Dec 28, 2020

News Release

SOLVD Health Prepares to Launch Clinical Study of Non-Invasive Colorectal Cancer Screening Test

LifeKit® Prevent is the only non-invasive colorectal cancer screening test designed to accurately detect the earliest warning signs of cancer—precancerous adenomas.

CARLSBAD, Calif., January 6, 2021 – SOLVD Health, a privately held company focused on preventing disease by making actionable and contextual health information accessible to everyone, is preparing to launch a U.S. clinical study of its non-invasive colorectal cancer (CRC) screening test, LifeKit® Prevent. The test is being developed in partnership with Metabiomics, a subsidiary of SOLVD Health. The PREVENT study protocol is now available on the U.S. National Library of Medicine’s ClinicalTrials.gov database, which includes privately and publicly funded clinical studies conducted around the world.

LifeKit Prevent is a qualitative in vitro diagnostic test that is designed to detect and analyze microbial genomics biomarkers in human stool samples that are strongly associated with specific stages of CRC progression. The test is intended to aid in the detection of precancerous and cancerous lesions (colorectal neoplasia), including advanced adenomas and carcinomas, in an average-risk screening population in accordance with recognized screening guidelines.

When compared to currently available options, LifeKit Prevent is the only non-invasive CRC screening test designed to accurately detect the earliest warning signs of cancer—precancerous adenomas. In an effort to prevent cancer from developing, when adenomas are detected, the patient will undergo a colonoscopy, and the adenomas will be removed.

“Colonoscopy is the current gold standard for colorectal cancer screening because it accurately detects cancer as well as precancerous adenomas,” said Keri Donaldson, MD, CEO of SOLVD Health. “However, because it is highly invasive, patient compliance rates are poor. Currently available non-invasive alternatives have been shown to effectively detect cancer, but not precancerous adenomas. Early research has shown that our test is effective at detecting both, which could be a gamechanger for colorectal cancer screening.”

Research published in BMJ Open Gastroenterology showed that LifeKit Prevent is able to accurately detect precancerous colon polyps, achieving >80% accuracy. In 2019, the test received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) due to its potential to provide more effective diagnosis of a life-threatening disease and offer significant advantages over existing alternatives.

SOLVD Health’s prospective clinical trial will enroll up to 12,000 individuals to validate its test for the detection of colorectal cancer and adenomas. Subjects will include adults at average-risk for colorectal cancer between the ages of 45 and 84.

About Colorectal Cancer

Despite being one of the most preventable forms of cancer, colorectal cancer is the second leading cause of cancer deaths in the U.S. In 2020, the American Cancer Society estimated that 148,000 Americans would be diagnosed with colorectal cancer, and another 53,000 would die from it. The U.S. Department of Health & Human Services estimates that approximately 60% of colorectal cancer deaths could be prevented with screening, but one in three Americans who should get tested for colorectal cancer has never been screened.

About SOLVD Health

SOLVD Health is a privately held company focused on preventing disease by making contextual health information accessible to everyone. Through the development of insights-based health tools, we are enabling individuals and their providers to make better decisions about their health and the health of their families. We accomplish this by translating complex biological signals into actionable patient data that can point the way to better health. To learn more about us, our solutions, and our career opportunities, visit us at www.solvdhealth.com.

Media Contact:
Janelle Drumwright; pr@solvdhealth.com 

 

Introducing SOLVD Health, A Patient Intelligence Company

Introducing SOLVD Health, A Patient Intelligence Company

Dec 4, 2020

Currently, most of us only interact with the healthcare system after we get sick. Because we often don’t seek care until after we’ve started experiencing symptoms, many health conditions are diagnosed too late and require treatment to manage them. The effects of disease, treatment, and the side effects of treatment not only cause suffering for patients and their families, but also social, emotional, and financial hardship. Yet many of these diseases are completely preventable.

Our Mission

At SOLVD Health (formerly Prescient Medicine), our mission is to solve some of healthcare’s biggest challenges by bringing contextual and actionable health information to everyone, before they get sick. Our work is driven by our belief in creating a world where people don’t have to become patients.

This is a big, bold vision, and we’re ready and eager to rise to the challenge. That’s because we believe the key to our future health lies within us. Modern technology and big data have made it possible to identify early warning signs from our bodies, known as biological signals, that can predict our risk for disease and our future health before we ever get sick. We call this information Patient Intelligence.

Patient Intelligence

In order to prevent disease and realize our health potential, we must first understand the signals of disease. Through the discovery and conversion of biological signals into predictive, actionable, and contextual Patient Intelligence, we are enabling individuals and their healthcare providers to make better decisions about their health and the health of their families.

By combining genetics-based patient insights with cutting-edge technologies like machine learning and custom algorithms, Patient Intelligence has the potential to transform healthcare by:

• Empowering patients and their healthcare providers with objective, actionable information to keep them healthy
• Giving patients insights about their future health risks and helping engage them as a partner in their health management
• Enabling healthcare professionals to make data-driven decisions with more confidence and efficiency
• Enabling healthcare systems to stratify the health risks within their populations at scale, so that they can identify high-risk individuals and deliver the right prevention strategies at the right time

Patient Intelligence changes the relationship we have with our health system from only engaging when we are sick to having an ongoing relationship that is focused on keeping us healthy. Patient Intelligence puts our illness-focused care system on the path to becoming a modernized, true health system. We believe that Patient Intelligence leads us to a future where health is possible for everyone.

Our Core Values

At SOLVD Health, our core values form the heart of our company, guiding everything from our product design philosophy to our regulatory strategy to our customer communications and our hiring practices. These values are what we prioritize day in and day out as we work toward creating a world where people never have to become patients.

Thoughtful:

We are intentional and purposeful about everything we do.

• We find biological signals that would convert to viable products and bring them to market responsibly.
• We take a data-driven approach and work hard to generate the evidence we need to make sure people are confident when they do business with us.
• Our product design philosophy requires that our products:
– Meet regulatory requirements
– Are useful
– Are safe and effective
– Have economics that work
– Have evidence to back them up
– Are accessible
• We create and sustain a workplace where everyone is aligned with our company mission, goals, and values.

Compassionate:

We put people at the heart of everything we do.

• People and their health are our number one priority.
• We don’t just sell tests—we want to improve people’s lives.
• We go above and beyond to understand patients’ and providers’ needs.
• We strive to create products and solutions that patients and their providers can trust to confidently access their health information.
• For healthcare teams, we care deeply about making it easier for them to care for patients. We go beyond just building products—we build tools, education programs, and a community that supports them so they can do what they do best.
• We are authentic, empathetic, and respectful in the way we communicate and treat each other.
• Our employees are valued and feel like active contributors.

Visionary:

We see opportunity in the biggest healthcare challenges.

• We have the courage to solve the biggest unmet needs in healthcare, problems that others have not been brave enough to tackle. We do so by:
– Identifying novel biological signals that can be translated into health products that solve large unmet health problems
– Creating a unique business model that ensures that impactful products can get to the people who need them quickly
– Building a platform that enables continuous discovery of novel biological signals
– Partnering strategically to go beyond providing information, to also provide interventions
• We believe innovation is about taking risks and encourage our employees to think differently and think bigger so we can solve big challenges together.

Empowering:

We empower people to take action through knowledge.

• We believe that knowledge is power.
• Our products are designed to put people and their care teams in control of their future health by giving them the actionable and contextual information they need to make lifestyle and healthcare decisions to prevent disease.
• We empower healthcare providers to make data-driven decisions about treatment plans and interventions so that they can treat their patients with confidence.
• We hire great people and trust them to do their jobs.
• We give our employees the tools, training, and support they need to be successful.

Clarity:

We are determined to bring clarity where there is ambiguity.

• We focus on building products for people and their care teams that:
– Provide clarity about their health risks
– Have clear actions/interventions that they can take to mitigate risk
• Our approach is to be clear and transparent in our communications with our customers, partners, and across the company (vertically and horizontally), always.
• We are clear about our mission and what we need to focus on to get there.

Join Us

We are convinced that predictive, contextual, and actionable health insights can be used to prevent disease and transform healthcare for everyone. Our goal is to accelerate the development of these much-needed health insights, bring them through the regulatory process, and make them available to healthcare providers and their patients. Join us on our journey by signing up for our email list below and follow us on LinkedIn.