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NY State Rescinds Conditional Approval of Four Rosetta Genomics PCR Assays

NEW YORK (GenomeWeb) – In a filing with the US Securities and Exchange Commission, Rosetta Genomics said the New York State Department of Health has rescinded its conditional approval of four of the company's allele-specific PCR-based assays.

The tests — designed to detect BRAF, EGFR, KRAS, and NRAS mutations in lung, colon, and melanoma cancers — were granted NYSDOH conditional approval in May. The four assays were already CLIA certified, but Rosetta requires additional licenses from the NYSDOH to offer the tests in the state. As a condition of the process, the company was also required to provide any additional information requested by the agency within 60 days in order to receive final approval.

"The NYSDOH had a number of questions regarding the company's standard operating procedure for these assays," Rosetta said in its SEC filing. "The company is working with the NYSDOH to address these questions. The company is confident that it will be able to address the concerns raised by the NYSDOH and plans to resubmit for NYSDOH approval as soon as possible."

In the meantime, Rosetta added, it will not process patient samples for these four assays in New York, but will continue to process patient samples from the rest of the country as the NYSDOH rescission will not affect its business in the other 49 states.

Rosetta has received several conditional approvals from the NYSDOH for various tests, including the latest one in June for certain of its multiple fluorescence in situ hybridization (FISH) cancer tests.