SOLVD Health Receives CE Mark for Genetic Risk Assessment for Opioid Use Disorder
This new genetic test is designed to analyze 15 genetic variants to identify patients who may be at increased risk for opioid addiction
CARLSBAD, Calif., December 7, 2020 – SOLVD Health, a privately held company focused on preventing disease by making actionable and contextual health information accessible to everyone, announced today that its genetic risk assessment for opioid use disorder (OUD) has received CE mark certification. The CE mark is legally required to place a device on the market in the European Union (EU).
As part of SOLVD Health’s broader regulatory strategy for this new public health solution, the certification gives European clinicians and their patients access to an important tool to help prevent opioid addiction. Using a simple cheek swab sample, the risk assessment is designed to analyze 15 genetic variants involved in the brain reward pathway to identify patients who may be at increased risk for OUD. Healthcare providers can use this personalized risk information to make more informed decisions about the use of oral opioids for acute pain when developing pain management plans for their patients. This technology received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) in February 2018.
“Although the opioid crisis has been an ongoing public health issue in the United States for years, European countries are not immune to the problem,” said Keri Donaldson, MD, CEO of SOLVD Health. “Any time prescription opioids are used to manage pain, there is a risk of addiction. Knowing a patient’s risk prior to opioid exposure gives clinicians and patients the data they need to make more informed decisions. We are excited to deploy our technology in European health systems, where it has the potential to help prevent a major public health issue.”
In 2019, SOLVD Health partnered with the Department of Clinical Chemistry at Erasmus MC (CC-EMC), Rotterdam, to conduct clinical research with patients in The Netherlands and other areas of Europe. The goal of the research is to confirm that the positive results from research completed in the United States are also found in European healthcare systems. According to a 2019 study, the overall number of prescription opioid users in The Netherlands nearly doubled between 2008 and 2017, and the number of opioid-related hospital admissions tripled.
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, on Twitter, or at www.solvdhealth.com.
Janelle Drumwright; firstname.lastname@example.org