CombiMatrix's (CBMX) CombiPGS Test Receives Conditional Approval in New York

November 29, 2016 6:09 AM EST

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CombiMatrix Corporation (Nasdaq: CBMX) announces that its pre-implantation genetic screening (PGS) by next generation sequencing (NGS) test has received conditional approval from the New York State Department of Health. The CombiPGS™ test is for women undergoing in vitro fertilization (IVF) and screens embryo biopsy cells for chromosomal abnormalities prior to implantation of the embryo. The test assists in maximizing the chance of successful implantation and pregnancy progression, while decreasing the likelihood of miscarriage.

“We launched CombiPGS using NGS technology in June of this year as NGS allows for unequaled accuracy and sensitivity in the detection of whole chromosome and segmental aneuploidies, which is crucial in providing the highest quality results for this test,” said Mark McDonough, President and Chief Executive Officer of CombiMatrix. “CombiPGS by NGS is an important upgrade to our portfolio of reproductive health tests and we are pleased by the strong reception it has received from reproductive endocrinologist and IVF physicians who are key call points for this test.

“We are now marketing CombiPGS by NGS in New York State, which ranks second in the total number of IVF cycles performed nationally each year. With this approval, physicians and their patients across the U.S. can access our full portfolio of reproductive health tests and capitalize on our industry-leading experience and our high-touch clinical support. For CombiMatrix, this is a promising cash-pay market that we estimate to be approximately $125 million annually in the U.S. and growing. We expect CombiPGS will be an important contributor to revenue as we target cash flow breakeven by the fourth quarter of 2017."



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