Rosetta Genomics, a leading developer and provider of microRNA-based molecular diagnostics, today announced that OncoGxSelect, Admera Health’s latest next-generation sequencing (NGS) oncology panel, has been approved for clinical use by The New Jersey Department of Health (NJDH).
OncoGxSelect will be the sixth new product introduced by Rosetta Genomics in 2015. The Company expects to launch its seventh new product, a microRNA-based assay for accurate thyroid nodule classification, by the end of this quarter.
OncoGxSelect leverages Admera Health’s industry-leading NGS technology. It interrogates 5 genes associated with highly-prevalent lung cancer types including KRAS, BRAF, EGFR, ROS1 and ALK.
It detects point mutations, small insertion/deletions (indels) and gene fusions to provide clinically actionable results. OncoGxSelect is performed on a modest-sized pathology sample in the standard format of FFPE (formalin fixed paraffin embedded) tissue, the same as Rosetta’s other clinical microRNA-based diagnostics.
In lung cancer, the addition of OncoGxSelect adds to an already broad, comprehensive lung-specific menu to assist in answering the most difficult clinical questions that face clinicians treating lung cancer patients.
While OncoGxSelect focuses on lung cancers, OncoGxOne, another of Admera Health’s NGS tests launched by Rosetta Genomics last month, interrogates all types of genomic aberrations in 64 genes, specifically 56 related to cancer targeted therapy and 8 related to chemotherapy. This test covers all exons and 5′ and 3′ UTRs for each gene, as well as all introns that harbor potential gene translocation breakpoints.
With Rosetta Genomics’ comprehensive diagnostic testing services, treating physicians now have an array of clinically relevant options to choose from, whether they want to confirm primary diagnosis, clarify tumor subtype, perform a full oncogenomic profile or focus exclusively on lung-specific biomarker targets via NGS, FISH, PCR and/or IHC.
"We are excited to launch OncoGxSelect as part of our productive partnership with Admera Health. OncoGxSelect is valuable to clinicians and patients struggling with a cancer diagnosis as it directs the physician to the appropriate targeted treatment, truly delivering personalized medicine," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.
Rosetta Cancer Tests are a series of microRNA-based diagnostic testing services offered by Rosetta Genomics. The Rosetta Cancer Origin Test can accurately identify the primary tumor type in primary and metastatic cancer including cancer of unknown or uncertain primary (CUP). The Rosetta Lung Cancer Test accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells.