Rosetta Genomics (ROSG) Receives Rescission of Conditional Approval from NYSDOH; Will Not Process CAST PCR-Based Assays in New York
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Rosetta Genomics (Nasdaq: ROSG) announces that the Company received notice of rescission of conditional approval from the New York State Department of Health (NYSDOH) for four of the Company’s allele-specific PCR (CAST PCR)-based assays to test for BRAF, EGFR, KRAS and NRAS mutations in various cancers, which are processed at at its Lake Forest, California facility. The NYSDOH had a number of questions regarding the Company’s standard operating procedure for these assays. 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 interim, the Company will not process samples for these four assays from patients in New York. Rosetta will continue to process these mutational assays from patients in the other 49 states of the United States.
The NYSDOH rescission only affects the four assays noted above and has no effect on the Company’s ability to process samples from its other assays that have been approved by the NYSDOH or are otherwise permitted to be run on patients in New York.
The information contained in this Report is hereby incorporated by reference into the Company’s Registration Statements on Form F-3, File Nos. 333-163063, 333-171203, 333-172655, 333-177670, 333-185338, 333-207697 and 333-210366.
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