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

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 The FDA also published draft guidance on Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder in July 2023.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

Prescient Medicine Holdings is Now SOLVD Health

SOLVD Health’s mission is to prevent disease by making actionable health information accessible to everyone

CARLSBAD, Calif., December 1, 2020 – Prescient Medicine Holdings, Inc., a privately held company focused on developing insights-based health tools, today announced its rebrand to SOLVD Health. The new name and brand reflect the company’s mission to solve some of healthcare’s biggest challenges through preventative health solutions that combine genetics-based patient insights with cutting-edge technologies.

“As we drive toward commercialization of our two breakthrough tests for opioid use disorder and colon cancer, we believe the time is right to evolve our brand to reflect the current and future potential of our innovation platform,” said Keri Donaldson, M.D., Chief Executive Officer of SOLVD Health. “At SOLVD Health, our goal is to create much-needed predictive and actionable health insight tools and make them available to healthcare providers and their patients.”

SOLVD Health will focus on the development and commercialization of its innovative technologies, which utilize machine learning and custom algorithms. These technologies include two groundbreaking tests, which have both been granted Breakthrough Device designations by the U.S. Food and Drug Administration (FDA). One is a genetic test designed to identify people at increased risk for opioid use disorder (OUD) prior to taking oral prescription opioids. The other test analyzes an individual’s microbiome and is designed to detect colorectal cancer and precancerous adenomas.

“At SOLVD Health, we aim to prevent people from becoming patients,” said Dr. Donaldson. “By providing contextualized insights before symptoms occur – a model that we call Patient Intelligence – we can improve patients’ lives while also changing how we think about and conduct healthcare as a society.”

To learn more, visit the new SOLVD Health website at www.solvdhealth.com.

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 on LinkedIn or at www.solvdhealth.com.

Media Contact:
Valerie Melucci; pr@solvdhealth.com 

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.

Metabiomics and the Harvard Chan Microbiome in Public Health Center Collaborate to Advance Research in Colon Cancer Screening

CARLSBAD, Calif., June 2, 2020 – Prescient Metabiomics, a subsidiary of Prescient Medicine Holdings, Inc., announced today a research collaboration with the Harvard Chan Microbiome in Public Health Center (HCMPH Center), a group at the Harvard T.H. Chan School of Public Health dedicated to expanding research on the microbiome to improve public health. The aim of the collaboration is to study microbial biomarkers to identify the presence of precancerous adenomas and carcinomas in the colon. The initial collaboration will investigate prevalent gut microbial biomarkers for colorectal cancer (CRC) by analyzing known, recent CRC cases across populations with which the HCMPH Center works and applying cutting-edge statistical and bioinformatic techniques for microbiome meta-analysis.

“The ongoing research collaboration will further enhance diagnostic screening for colon cancer,” said Keri Donaldson, M.D, chief executive officer at Prescient Medicine. “Offering a non-invasive alternative to colonoscopies that screen for colorectal adenomas and carcinomas could represent a paradigm shift in CRC screening driven by the microbiome. Therefore, research to better understand the microbiome’s role in CRC is needed at this time.”

Curtis Huttenhower, Ph.D., professor of computational biology at Harvard Chan School and co-director of the HCMPH Center, said, “The mission of the HCMPH Center is to improve population health via microbiome science, and there are few chronic disease conditions as well-positioned to benefit from microbiome screening as colorectal cancer. It is one of the most common causes of cancer deaths, but also one of the most preventable cancers if detected early. It’s exciting to embark on this collaboration to advance the latest science and, I hope, eventually deploy our findings to the clinic.”

The past decade has seen a dramatic expansion of research on the human microbiome, including investigation into the role of microbes and microbiota in the gastrointestinal track in the origin and development of CRC. The advancements in this field parallel the preceding decade’s growth in personalized genetic medicine, with the microbiome offering opportunities for both therapeutic and diagnostic biomarker discovery.

According to the American Cancer Society, colorectal cancer is the third leading cause of cancer-related deaths in both men and in women. The U.S. spends approximately $14 billion each year for the diagnosis and treatment of CRC with costs largely due to delayed detection. There is a lack of non-invasive screening tests that can accurately detect precancerous polyps as effectively as a colonoscopy, the current standard of care. Screening recommendations currently suggest a colonoscopy for average-risk patients starting at age 45 every 10 years and earlier for high-risk patients, but approximately one in three patients are not in compliance with these recommendations. Research indicates that early detection of precancerous adenomas and carcinomas could lead to significantly better patient outcomes.

About Metabiomics

Prescient Metabiomics LLC, a privately held company and subsidiary of Prescient Medicine Holdings, Inc., is an early stage molecular diagnostics company developing in-vitro diagnostics that leverage breakthroughs in next-generation DNA sequencing, computational systems biology, and human microbiome sciences. To learn more, visit us at www.metabiomics.com

About SOLVD Health

SOLVD Health (formerly Prescient Medicine) 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; pr@solvdhealth.com