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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 The FDA also published draft guidance on Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder in July 2023.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.

Management Solutions for Opioid Epidemic Are Similar to Management of the COVID-19 Pandemic

Management Solutions for Opioid Epidemic Are Similar to Management of the COVID-19 Pandemic

by | Sep 21, 2020 | News

News Release

Management Solutions for Opioid Epidemic Are Similar to Management of the COVID-19 Pandemic

Pharmacy Times® interviewed Keri Donaldson, medical director and CEO of Prescient Medicine, about the effects of the COVID-19 pandemic on the opioid epidemic in the United States.

The discussion included how the opioid epidemic in the United States has been affected by the COVID-19 pandemic, how exacerbating mental health problems during the pandemic may lead to increased challenges, whether national efforts to address the opioid epidemic have changed during the pandemic, whether any current efforts to support those affected by the pandemic are also supporting those affected by the opioid epidemic, and why it is necessary to develop effective public health solutions to help manage the opioid addiction crisis.

Donaldson explained that there are many similarities between the COVID-19 pandemic and opioid epidemic in terms of practical solutions.

“The first thing is making sure that you can treat it. Making sure that you have the hospital beds, making sure you have the ventilators—that same analogy [works] in opioid use disorder when we’re making sure people have access to treatment programs and making sure they have safe places to live,” Donaldson said.

He noted that similarly to the COVID-19 pandemic, the next portion of the solution is prevention.

“As we live through this process, you’re seeing people talk about increased testing, increased surveillance, contact tracing, and then as we roll back even further, god willing, we’re going to get to this point where we’re talking about, ‘Okay what about a vaccine?’ And that’s prevention on a public health scale for COVID-19,” Donaldson said. “That same equivalent in opioid use disorder is understanding who’s most at risk and making sure we standardize the process so that each individual is informed—the patient, the provider, the prescriber, and the pharmacist—prior to prescribing so they can objectively understand if a patient has an increased risk prior to filling that first medication.”

Donaldson also discussed how racial disparities have come into play in the opioid epidemic to exacerbate current disparities even further, how obtaining data can clarify the nature of these racial disparities within the opioid epidemic, what pharmacies can do to support the process of addressing the opioid epidemic during COVID-19, what the value of a pharmacist is in supporting communities affected by the opioid epidemic, and what changes are needed in the future for the country’s response to the opioid epidemic.