Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced that its wholly owned subsidiary, the Sequenom Center for Molecular Medicine (Sequenom CMM), has completed the build-out and validation of an additional laboratory location in Raleigh-Durham, NC, and is now processing patient samples commercially. This new laboratory location adds capacity and redundancy to the existing Sequenom CMM laboratory locations in California and Michigan.
With an initial capacity of 100,000 tests per year, the North Carolina facility will primarily support processing of the MaterniT21 PLUS laboratory-developed test (LDT) and will immediately increase Sequenom CMM's total MaterniT21 PLUS testing capacity to over 300,000 test samples per year. This practice-changing prenatal LDT analyzes the relative amount of chromosome 21, 18, and 13, as well as X and Y material in cell-free fetal DNA obtained from a maternal blood sample as early as 10 weeks of pregnancy.
"We are excited about the opening in North Carolina of our third US-based laboratory location. Our investment in establishing this new presence on the East coast will allow us to better meet the needs of health care providers by providing critical additional capacity and geographic back-up needed to address the rapidly growing adoption of our testing services," said William Welch, President and COO, Sequenom, Inc.
The new laboratory location received its Clinical Laboratory Improvement Amendments (CLIA) registration for operation in May of 2013.
The MaterniT21 PLUS LDT is intended for use in pregnant women at increased risk for fetal aneuploidy. Estimates suggest there are about 750,000 pregnancies at high risk for fetal aneuploidy each year in the United States. The MaterniT21 PLUS test is available exclusively through the Sequenom CMM as a testing service provided to physicians.
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