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SOLVD Health Receives New York State Laboratory Approval

SOLVD Health Receives New York State Laboratory Approval

by | Dec 26, 2024 | Genetics, Healthcare, News

SOLVD Health Receives New York State Laboratory Approval

SOLVD Health has received approval from the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) for its San Diego-based laboratory. This approval authorizes SOLVD Health to offer AvertD® for patients in New York, empowering healthcare providers and patients with critical insights to help mitigate the risk of opioid use disorder (OUD).

The New York State Department of Health is recognized for its rigorous standards in clinical laboratory testing, ensuring that approved laboratories meet high benchmarks for accuracy, reliability, and patient safety. SOLVD Health’s AvertD®genetic test, already FDA-approved, is designed to assess individual genetic susceptibility to OUD, providing valuable information to guide personalized pain management strategies.

“Securing New York State approval is a pivotal step in our mission to expand access to genetic testing that can help address the opioid crisis,” said SOLVD Health founder and CEO Dr. Keri Donaldson. “This expansion enables more healthcare providers and patients to benefit from personalized health insights that can inform decisions about pain management and potentially prevent adverse outcomes.”

As the healthcare industry continues to seek solutions to combat the ongoing opioid epidemic, AvertD offers clinically validated genetic insights that can help them advise pain management decisions before opioid therapy begins. This approval advances SOLVD Health’s mission to translate complex biological signals into actionable patient data, empowering individuals and healthcare providers to make more informed health decisions.

Media Contact:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

SOLVD Health Launches 5-Year Post-Approval Study for AvertD® Genetic Test

SOLVD Health Launches 5-Year Post-Approval Study for AvertD® Genetic Test

by | Nov 18, 2024 | Genetics, Healthcare, News

SOLVD Health Launches 5-Year Post-Approval Study on Real-World Impact for AvertD® Genetic Test

SOLVD Health has launched a comprehensive post-approval study for AvertD®, the first U.S. Food and Drug Administration (FDA)-approved genetic test for assessing risk of developing opioid use disorder (OUD). This post-approval study aims to expand upon pivotal study findings and further demonstrate AvertD’s ability to enhance personalized data-driven decisions in real-world settings.

The prospective study will enroll up to 4,000 patients, integrating agile methods to gather comprehensive, real-world data from diverse demographic groups across the United States. Designed to confirm AvertD’s predictive accuracy across diverse populations, the study seeks to equip providers with critical insights for individualized, evidence-based pain management.

“The launch of our post-approval study for AvertD represents more than our commitment to regulatory requirements. It’s a commitment to addressing one of the most pressing public health challenges of our time,” said SOLVD Health Founder and CEO Dr. Keri Donaldson. “Every day, healthcare providers and their patients face challenging decisions about pain management. Our goal is to arm them with precise, personalized insights to guide these critical decisions and improve patient outcomes.”

The study will follow participants for up to five years, providing additional long-term data on the predictive value of genetic testing in OUD risk assessment. The extended timeframe will enable researchers to observe how genetic risk factors interact with environmental and behavioral influences over time, potentially uncovering new strategies for addiction prevention and intervention.

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, SOLVD Health enables individuals and their providers to make better decisions about their health and the health of their families. SOLVD Health accomplishes this by translating complex biological signals into actionable patient data that can point the way to better health.

Media Contact:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

SOLVD Health Receives New York State Laboratory Approval

FDA Gives PMA Supplement Approval for Use of INFINITI HTS with AvertD®

by | Nov 12, 2024 | News

SOLVD Health Receives FDA PMA Supplement Approval for Use of INFINITI High-Throughput System with AvertD®

SOLVD Health has received U.S. Food and Drug Administration (FDA) PMA supplement approval for its INFINITI High Throughput System (HTS) to be used with AvertD®.

The HTS instrument expands daily processing capacity, designed to work seamlessly with SOLVD Health’s entire test portfolio, including AvertD®, the first FDA-approved genetic test for assessing elevated risk for developing opioid use disorder (OUD). The development marks a major advancement in SOLVD Health’s ability to deliver critical health insights at scale.

“This system is about more than increasing output. It’s about amplifying our impact,” said SOLVD Health Founder and CEO Dr. Keri Donaldson. “With the HTS, we’re enabling access to cutting-edge genetic insights and opening new possibilities for personalized medicine and preventive health care.”

The HTS underwent rigorous FDA evaluation to ensure it produces results consistent with the organization’s already approved INFINITI PLUS Analyzer. The HTS is a semi-automated, scalable, and multiplexed microarray analysis system that increases throughput to 960 samples in approximately 8 hours compared to 48 samples on the INFINITI PLUS. This efficiency, combined with the cost-effective and readily available DNA processing equipment, significantly enhances workflow optimization.

“This approval underscores our commitment to innovation and clinical excellence,” added Dr. Donaldson. “We’re poised to make a broader impact on critical health issues, including the opioid crisis, by making advanced genetic insights more accessible to health care providers and patients.”

The approval marks another milestone in SOLVD Health’s mission to translate complex biological signals into actionable patient data, empowering individuals and health care providers to make more informed health decisions.

Media Contact:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

FDA Approves First Test to Identify Elevated Risk of Developing OUD

FDA Approves First Test to Identify Elevated Risk of Developing OUD

by | Dec 19, 2023 | News

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:
Valerie Melucci
Vice President of Marketing, SOLVD Health
pr@solvdhealth.com

Investors:
Mark Hazeltine
Chief Financial Officer, SOLVD Health
investors@solvdhealth.com

What is Pharmacogenomics (PGx) Testing?

by | May 10, 2021 | Insights

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

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 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, 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.