NEW YORK (GenomeWeb News) – Sequenom's shares rose as much as 14 percent today after the firm said that it is launching its long-awaited trisomy 21 test following the publication of clinical data in a peer-reviewed journal.
The San Diego-based firm today announced the test called MaterniT21 would be available in 20 major metropolitan regions across the US as a laboratory-developed test from its Sequenom Center for Molecular Medicine subsidiary, sending the stock as high as $6.06 per share during the day before retreating to $5.65 by mid-afternoon.
The stock closed on Friday at $5.32.
More than 4.4 million shares of Sequenom stock had exchanged hands with about two hours left in the trading session, almost three times the average daily volume of about 1.5 million shares during the past three months.
In addition to launching the sequencing-based MaterniT21 as an LDT, Sequenom has been in discussions with the US Food and Drug Administration about the test and has previously said it hopes to submit an application to the agency by the end of 2012 for clearance.
The test's belated launch follows a two-year long investigation into Sequenom by the US Securities and Exchange Commission into activities around the test and a scandal surrounding the mishandling of R&D data for the test.
An investigation by Sequenom's board of directors led to the dismissal of President and CEO Harry Stylli and Senior VP of R&D Elizabeth Dragon, among others, from the firm in September 2009. Dragon died earlier this year.
Meanwhile, the SEC investigation wrapped up last month with a cease-and-desist order from the agency related to public statements made previously by Sequenom about the test.
The MaterniT21 test will be processed at the Sequenom CMM CLIA-certified laboratory in San Diego. On average, test results will become available in eight to 10 days after submission, Sequenom said, adding that the out-of-pocket cost for the test will be no more than $235.
The test is indicated for use in pregnant women at high risk for carrying a fetus with Down syndrome. There are an estimated 750,000 such pregnancies in the US each year, Sequenom said.
The company also said today that a clinical validation study leading to the introduction of the test has been published in Genetics in Medicine. According to the study of 1,696 samples, including 212 samples with Down Syndrome, MaterniT21 achieved a detection rate of 98.6 percent. The false positive rate was .2 percent and testing failed to yield a result in 13 pregnancies.