Prescient Medicine Holdings announced it has acquired AutoGenomics a privately-held U.S. molecular diagnostics company, which has developed and commercialized the INFINITI® platform – a 510(k) exempt, automated, microarray-based multiplexing diagnostic system with applications in personalized medicine, pain management, cardiovascular health, mental health, women’s health, oncology, infectious diseases and genetic disorders.
The acquisition of AutoGenomics will enable Prescient Medicine to advance the development and commercialization of the INFINITI® Neural Response Panel, a novel diagnostic test for the identification of patients who may be at risk for opioid use disorder (OUD), leveraging the work of both companies completed through a collaboration initiated in 2017.
The INFINITI® Neural Response Panel identifies genetic mutations involved in the brain’s reward pathways associated with increased risk of opioid use disorder. The U.S. Food and Drug Administration (FDA) has granted the INFINITI® Neural Response Panel a Breakthrough Device designation. Prescient Medicine and AutoGenomics intend to pursue a de Novo premarket submission. Prescient Medicine will market the INFINITI® Neural Response Panel as LifeKit® Predict to provide physicians with objective information to help assess the risk of developing an addiction to oral opioids.
According to the CDC, the total economic burden of prescription opioid misuse in the U.S. is more than $78 billion annually. Approximately 68% of the more than 70,200 drug overdose deaths in 2017 involved an opioid, and 36% of those deaths involved prescription opioids. On average, 130 Americans die from an opioid overdose.
In addition to the INFINITI® Neural Response Panel, the AutoGenomics acquisition provides Prescient Medicine with access to the entire INFINITI® product portfolio including the suite of INFINITI® analyzers and a menu of over 65 molecular diagnostic tests across critical disease indications, which will complement Prescient Medicine’s LifeKit® product line of diagnostics.
“Acquiring AutoGenomics provides a robust platform which will accelerate our efforts and advance our delivery of novel diagnostic solutions designed to address the most pressing issues in healthcare, including the opioid crisis,” said Keri Donaldson, Chief Executive Officer of Prescient Medicine. “The combination of the AutoGenomics platform and Prescient Medicine’s existing toxicology and pharmacogenomic solutions allows us to immediately deliver high-value, enhanced services to both firms’ existing clients and the market.”