New genotyping test adds a positive note to lab

February 22, 2010
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The owner of a Grand Rapids laboratory last week announced it has released a fetal gender test, the third of Sequenom Inc.’s diagnostics lines to be processed here.

That test, along with one released earlier this month, another released last year and one more planned for 2011, are moving the company closer to bringing more jobs to the Sequenom Center for Molecular Medicine in Grand Valley State University’s Cook-DeVos Center for Health Sciences, company spokesman Ian Clements said.

“As we ramp up our tests, where necessary we will need to add personnel, whether that be in San Diego or whether that be in Grand Rapids or whether that be out in the field from a sales force perspective,” Clements said.

“What the timing and the quantity of those additional human resources are, at this point, I don’t know.”

In addition to the gender test, Sequenom announced earlier this month that it launched a new blood test for pregnant women that identifies the Rhesus D factor in the fetus. The SensiGene fetal RhD genotyping test, which was developed at and will be processed by the SCMM laboratory in Grand Rapids, is the first to reach the market that is based on technology licensed by the San Diego company.

Tests based on SEQureDx technology analyze DNA from fetal material in the mother’s bloodstream.

The two new tests provided a positive chord for Sequenom, which has been plagued with controversy, lawsuits and investigations over the botched clinical testing for another fetal diagnostic using SEQureDx technology to uncover Down syndrome.

Clements said the new tests show that the technology is commercially viable. It was developed by a Chinese professor and licensed by Sequenom from the University of Oxford’s ISIS Innovations Ltd. in the United Kingdom.

“From the company’s perspective, we have never doubted the utility or doubted the science behind the concept of using circulating cell-free nucleic acids, fetal nucleic acids, as a diagnostic tool,” Clements said.

“Launching our first test which utilizes the SEQureDx technology … shows this has commercial applicability and is a stepping stone in the right direction for us in terms of ultimately launching not only the next test, which is fetal sex determination using the same technology, but also the T-21 (Down syndrome) test at some point in the future.”

The company also announced last week a new licensing agreement with Optherian Inc., a New Haven, Conn., company that is developing diagnostic and therapeutic products for several gene-related diseases. This test, which will be processed at the SCMM, will test for genetic disposition to late-stage, age-related macular degeneration, which affects 15 million to 20 million people in the U.S. The test is expected to be released in early 2011.

Last year, the publicly held Sequenom issued a test, also processed in the Grand Rapids lab, which uses different technology to identify adult cystic fibrosis carriers.

“The uptake is beating our models,” Clements said of the CF test. “It’s fair to say it’s ahead of our expectations in terms of uptake, which we’re very pleased with.”

Sequenom purchased the CLIA-certified lab from Spectrum Health and the Van Andel Institute in 2008.

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