SCMM processing could ramp up by end of 2010
The Sequenom Center for Molecular Medicine in Grand Rapids could be processing sample tests for detecting Down syndrome by the end of the year, the company’s CEO and chairman said Thursday.
Harry F. Hixson Jr. also said the California public company is planning to add a second CLIA-certified laboratory to its facilities in lab space it already owns in San Diego.
“To anticipate demands, Sequenom plans to open a second CLIA-certified lab in it San Diego facilities, which will be operational by early fourth quarter 2010,” Hixson told analysts in a conference call regarding first-quarter financial results. “We plan to use it for validations and the launch of the T21 LDT (Laboratory-Developed Test).”
Blood samples from pregnant women at high-risk of delivering a child with Down syndrome would be processed at the SCMM lab, located in Grand Valley State University’s Cook-DeVos Center for Health Sciences, part of Grand Rapids’ Medical Mile, Hixson said. The samples are part of testing the company is performing to validate the effectiveness of the test.
“We anticipate the SCMM will start assessing those samples during the fourth quarter of 2010 to support the launch of the LDT by the end of the fourth quarter of 2011,” Hixson said. He said testing would be completed in the second quarter of 2011, followed by analysis of double-blind studies and submission of the study for publication in a peer-reviewed journal.
Sequenom’s SensiGene diagnostic tests already on the market generated $204,000 in revenue during the first quarter.
Sequenom also announced settlement agreements for two lawsuits related to last year’s data scandal. The company said a lawsuit filed against it by Xenomics Inc., now TrovaGene, was dismissed Tuesday.
On the market are Sequenom’s prenatal tests for fetal gender and RhD as well as a test to detect adult carriers of cystic fibrosis. The company also is developing a genetic test for age-related macular degeneration, a leading cause of blindness in those age 60 and older. Earlier this year, Sequenom introduced a new version of its MassARRAY platform for genetic testing.