Prescient Medicine issued the following announcement on April 23.
Prescient Medicine Holdings Inc. announced today it has acquired AutoGenomics Inc., 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 billionannually. 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 every day 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."
AutoGenomics Inc., a privately held company based in Carlsbad, CA, developed the first automated, microarray based multiplexing diagnostic platform that can be used to assess disease signatures with novel genomic and proteomic markers. AutoGenomics' molecular diagnostics proprietary technology platform is in use globally in clinical reference laboratories, contract research organizations (CROs), specialty clinics and hospital laboratories. The platform consists of a family of INFINITI® analyzers including the INFINITI® PLUS, a prepared sample to answer system, and the INFINITI® High Throughput System, which has the capability of producing over 6,000 patient results per day. The platform also includes five US FDA cleared tests and a menu of over 65 molecular diagnostic tests for potential application in the areas of personalized medicine (pain management, cardiovascular health assessment and mental health therapy), women's health, oncology, infectious diseases and genetic disorders. With the discovery of genes and their link to various disease states, the platform has the versatility to revolutionize the way patients are diagnosed, monitored and managed, leading to the era of precision medicine. www.autogenomics.com.
About Prescient Medicine Holdings Inc.
Prescient Medicine is a privately held company focused on providing diagnostic tools that advance the precision healthcare movement. Prescient Medicine's mission is to build powerful tests and analytic solutions to offer deep predictive insights so doctors and patients have the data they need to make better, more informed clinical decisions, and achieve the best possible patient outcomes. Prescient Medicine operates two CLIA-certified labs supporting ToxKit®, an advanced drug screening tool, and LifeKit® PreScript®, an advanced pharmacogenomic test with broad medication coverage and advanced drug-gene-drug analytics to ensure effective medication use. Other technologies in development include LifeKit® Predict, an in vitro diagnostic test commercialized in partnership with AutoGenomics used for the identification of patients who may be at risk for opioid dependency, as well as LifeKit® Prevent, an innovative microbiome diagnostic for detecting precancerous colon polyps. Prescient has locations in Pennsylvania, Illinois, and Kentucky. www.prescientmedicine.com.
Original source can be found here.