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NY Department of Health Conditionally Approves Rosetta Lung Cancer Assay

NEW YORK (GenomeWeb) – Molecular diagnostics firm Rosetta Genomics announced today that it has been granted conditional approval for its fluorescence in situ hybridization (FISH)-based ROS1 lung cancer biomarker assay from the New York State Department of Health (NYSDOH).

With the decision, the company said its ROS1 FISH assay, which was acquired through Rosetta's purchase of PersonalizeDx earlier this year, is now available in all 50 US states.

Separately, the company also said that the Accreditation Committee of the College of American Pathologists has approved reaccreditation to its Lake Forest, California laboratory.

ROS1 is a receptor tyrosine kinase of the insulin receptor family and is included in the National Comprehensive Cancer Network's guidelines as a relevant biomarker in non-small cell lung cancer, according to Rosetta.

"Combining the ROS1 lung cancer biomarker with FDA-approved ALK FISH and EGFR PCR testing provides actionable genomic targets, which enhances the oncologist’s treatment decision options," Rosetta President and CEO Kenneth Berlin said in a statement.

With final NYSDOH approval of the assay still pending, Rosetta said that it is required to provide additional information about the test to the agency within 60 business days.

Meanwhile, Rosetta announced that its Lake Forest lab was granted reaccreditation based on the results of an onsite inspection, which involved a review of the lab's records and quality control procedures for the past two years, as well as its equipment, safety record, and overall management.

"The quality of our laboratory and testing services has always been a core competency for Rosetta Genomics," Berlin said in a statement. "We remain committed to the development and performance of high-value as well as high-quality molecular diagnostic testing services that advance personalized medicine."