Life sciences company Sequenom announced that the Sequenom Center for Molecular Medicine (Sequenom CMM), the company's wholly owned subsidiary, has completed the build-out and validation of an additional laboratory in Raleigh-Durham, N.C., and is now commercially processing patient samples. The new lab adds capacity and redundancy to the company's other laboratories in California and Michigan.
The North Carolina facility will have an initial annual capacity of 100,000 tests and will chiefly support processing of the MaterniT21 PLUS laboratory-developed test (LDT), immediately increasing Sequenom CMM's total MaterniT21 PLUS testing capacity to more than 300,000 test samples each year. MaterniT21 is a prenatal LDT that 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 into pregnancy.
MaterniT2 PLUS LDT is meant to be used in pregnant women who are at increased risk for fetal aneuploidy. An estimated 750,000 pregnancies are at high risk for fetal aneuploidy every year in the U.S. MaterniT21 PLUS is exclusively available through Sequenom CMM as a testing service offered to physicians.
"We are excited about the opening in North Carolina of our third U.S.-based laboratory location," said Sequenom President and COO William Welch. "Our investment in establishing this new presence on the East Coast will allow us to better meet the needs of healthcare providers by providing critical additional capacity and geographic backup needed to address the rapidly growing adoption of our testing services."
In May 2013, the new laboratory location received its Clinical Laboratory Improvement Amendments (CLIA) registration for operation.
For more information, visit www.sequenom.com
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