Admera Health, a commercial stage New Jersey based Precision Medicine and Digital Health company, announced that it has received CLIA approval for its liquid biopsy cancer test. Approval was granted by the New Jersey Department of Health and involved the BRAF V600 tumor mutation frequently found in melanoma and also observed in non-small cell lung cancer, colorectal cancer, papillary thyroid cancer, ovarian cancer, glioma and gastrointestinal stromal tumor (GIST).
This regulatory milestone validates the company’s proprietary BEST Blocker Enrichment technology which can reliably isolate and amplify circulating cell-free tumor DNA (ctDNA) fragments in the bloodstream and then, using next generation sequencing technology and advanced bioinformatics analysis systems, identify actionable genetic mutations.
With this knowledge, oncologists can initiate targeted therapy, adjust their treatment, detect early recurrence and identify new clinical trials to extend the lives of cancer patients. The company expressed its belief that the Admera Health test’s limit of detection for ctDNA exceeds other technologies in the marketplace today and confirmed its ongoing efforts to add additional genes to its panel.
The liquid biopsy diagnostics market is one of the most rapidly growing, potentially market disruptive diagnostic technologies under development today. Liquid Biopsy, a non-invasive technique using blood, urine or cerebral-spinal fluid, holds the potential to reduce the need for invasive and sometimes inconclusive repeat tissue biopsies needed to either initially characterize a tumor located in a hard-to-reach or high risk area as well as monitor over time a number of evolving genetic mutations present in a tumor. This clinical knowledge enables proper selection of either approved targeted therapies or enrollment in clinical trials when a cancer appears to have genetic mutations to current therapy making it resistant to the current treatment being used.
JP Morgan, in its recent analysis of the liquid biopsy market presented at its 2016 Healthcare Conference, concluded that although liquid biopsy is still in the early stages of development they believed the market opportunity would reach $22B by 2020. Their report highlighted additional advantages over tissue biopsy as non-invasiveness, lower total test cost, quicker turn-around-time, the ability to capture tumor heterogeneity and ability to monitor recurrence and eventually institute screening. The report further presented results of its survey showing over 95% of pathologists believe liquid biopsy will be adopted by the clinic with a majority believing this will occur in the next 3-4 years.
Dr. Guanghui Hu, President and CEO of Admera Health, noted “this accomplishment validates an enormous amount of scientific work at our company to develop a breakthrough cancer detection technology of significant health benefit in record time using our own proprietary methods. This milestone highlights our company’s expertise in cancer biology, assay development, next-generation genomic sequencing and bioinformatics, aligned with our company’s stated objectives.”
Zeil Rosenberg, MD, Vice President for Medical Affairs, stated while attending the BIO CEO & Investor Conference in New York that “This approval represents a major milestone in successfully getting our product into the mainstream clinical marketplace. Our next steps are to expand the genetic mutations covered by this clinical panel. We are currently discussing the conduct of a definitive concordance study to show our technology’s sensitivity and specificity advantages with three major university affiliated medical centers.”