Lab Prepares Launch of Trisomy 21 Diagnostic Test

A new 650-m² laboratory will launch the Trisomy 21 (T21) diagnostic test; the launch is planned for the latter half of the year 2011.

The lab will perform validation for Sequenom's (San Diego, CA, USA) T21 noninvasive Down syndrome test. Ian Clements, senior director of the company's investor relations said that samples are currently being collected for a clinical study. About 4,000 samples will be run at the new facility in connection with the final validation of the T21 test.

The clinical trial is being led by scientists at the Women and Infants Hospital (Providence, RI, USA), which is affiliated with Brown University (Providence, RI, USA). The test is sensitive enough to identify fetal DNA circulating in the pregnant woman's blood.

Sequenom has a Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited lab, the Sequenom Center for Molecular Medicine, which runs the company's cystic fibrosis and SensiGene fetal Rhesus D genotyping tests. A test for age-related macular degeneration, to be launched in the first half of 2011, will also be run out of the Grand Rapids facility. Those tests are run on Sequenom's MassArray technology, whereas the T21 test will run on sequencing technology.

"This is basically an expansion of our lab network," remarked Mr. Clements. "The core of our sequencing expertise and knowledge is here in San Diego, hence it made sense to expand our network and build a CLIA lab here."

Sequenom has a CLIA-certified and CAP-accredited lab, the Sequenom Center for Molecular Medicine, which runs the company's cystic fibrosis and SensiGene fetal Rhesus D genotyping tests. A test for age-related macular degeneration, to be launched in the first half of 2011, will also be run out of the Grand Rapids facility.

These tests are run on Sequenom's MassArray technology, whereas the T21 test will run on sequencing technology.

Sequenom anticipates getting CLIA certification and CAP accreditation for the San Diego lab in Q4 2010, he added.

Related Links:
Sequenom
Women and Infants Hospital
Brown University