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CombiMatrix Sees Focus on CMA Pay off as it Reports 172 Percent Q4 Prenatal Testing Growth

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Things are looking up for CombiMatrix. The Irvine, Calif.-based molecular diagnostics firm this week reported preliminary revenue growth of 172 percent and 171 percent for billable prenatal tests in the fourth quarter of 2012 and full year 2012, respectively.

In addition, the firm said that overall billable testing volumes, including its de-emphasized oncology segment, grew 21 percent and 25 percent in the quarter and full year, respectively, compared to its 2011 results.

CombiMatrix did not break out its revenues for these segments. It expects to report operating results in late February and to file its annual report for 2012 with the US Securities and Exchange Commission in March.

CEO Judd Jessup attributed the spike in testing volumes to the firm's decision last year to focus its sales and marketing activities on prenatal chromosomal microarray analysis and to cut back on direct marketing support for its menu of oncology tests (BAN 8/14/2012). CombiMatrix did not abandon its oncology-related offerings — including tests for chronic lymphocytic leukemia and breast cancer — but instead opted to partner with other laboratories and companies that offer cancer testing, such as Clarient, to reach customers (BAN 5/15/2012).

"Our refocused commercial strategy began to kick in during the latter half of 2012 and especially in the fourth quarter," Jessup said in a statement this week. "We believe our focus on CMA in the prenatal and pediatric segments is allowing us to gain traction and market share as the technology landscape and standard of care changes," Jessup said.

Jessup also said that the publication of a set of studies that appeared last month in the New England Journal of Medicine had led to the increase in test volume. One study in particular, led by researchers at Columbia University Medical Center, indicated that chromosomal microarrays can provide more clinically relevant information than traditional karyotyping, and should become the standard approach in prenatal diagnostics going forward (BAN 12/11/2012).

In fact, the study's principal investigator Ronald Wapner, professor and vice chairman for research at the department of obstetrics and gynecology at CUMC, said in a statement at the time that should a non-invasive method of performing whole-genome screening of prenatal samples become available, "every woman who wishes will be offered microarray, so that she can have as complete information as possible about her pregnancy." Samples used in current array-based analyses are typically obtained via amniocentesis or other invasive procedures.

Wapner joined CombiMatrix's scientific advisory board last year (). Jessup said in August that CombiMatrix is working with Wapner and others to "make sure that CombiMatrix delivers a responsible message to the marketplace and is in the best position to take commercial advantage as the shift toward microarrays takes place" (BAN 8/14/2012).

According to Jessup, CombiMatrix expects the shift to array technologies supported by the NEJM publications to "continue to add momentum" in the prenatal and pediatric CMA market as 2013 progresses.

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