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New York Conditionally Approves CombiMatrix's Miscarriage Test for Fresh, FFPE Tissues

NEW YORK (GenomeWeb) – CombiMatrix today said that the New York State Department of Health conditionally approved the CombiSNP Array for Pregnancy Loss for testing on fresh and formalin-fixed, paraffin-embedded patient samples.

It is the company's second conditional approval from the state this month for the SNP-based chromosomal microarray analysis test, following a similar decision on CombiSNP for pediatric development disorders. Also, in June 2013, New York conditionally approved the test for miscarriage analysis on fresh tissue.

"The availability of this SNP-based CMA test provides New York physicians the flexibility to either use fresh tissue or stored FFPE tissue when fresh tissue is not available," CombiMatrix CEO Mark McDonough said in a statement.

Under conditional approval, the firm can market the test in New York while the test is under Clinical Laboratory Reference System review. After the review is completed, the test will either be fully approved for marketing, or New York can ask for additional information before making a final decision.

The Scan

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