Pharmacy News EU

July 28Sequenom officials Tuesday defended the San Diego biotechnology company’s prenatal genetic test for Down syndrome, saying it doesn’t need more intense oversight despite a warning letter from regulators.
"We believe that the test meets the definition of (a laboratory-developed test)," officials said in a document filed with the Securities and Exchange Commission.
Lab-developed tests traditionally haven’t been regulated by the Food and Drug Administration, but such tools have come under intense scrutiny in recent months after regulators stymied a plan by San Diego-based Pathway Genomics to sell genetic testing kits directly to consumers through Walgreens drugstores.
In a July 19 letter to Sequenom, the FDA said the company’s SEQureDx test appears to fall under the category of medical devices, which would require extensive clinical trials and agency approval before it could be sold commercially.
Sequenom officials hadn’t commented publicly about the letter until the SEC filing, which officially notified shareholders of the matter.
The company has been conducting clinical trials of the test in advance of selling the product through prescriptions ordered by doctors. Executives had planned to seek FDA approval of the tool, but only after it was already on the market.
Now, those plans might have to change, said Bud Leedom, publisher of the California Stock Report.
It’s not clear whether the FDA would accept Sequenom’s ongoing trials for medical device clearance or if the agency would force the company to conduct a new set of tests.
In its SEC filing, Sequenom insisted that SEQureDx complies with the lab-developed test designation and differs significantly from the more controversial genetic tests being sold directly to consumers, which claim to measure a wide range of risks for diseases and drug complications.
"The (SEQureDx) test is solely for use within our … laboratory and is not sold directly to the general public," they said. "Rather, samples are ordered by a physician, collected and sent to Sequenom for testing, and the results are reported back to the physician."
Company officials said they were preparing a response to the FDA.
Sequenom shares dipped to $5.69 in the days after the FDA letter was issued but rebounded by the end of last week. On Tuesday, shares fell 13 cents, or about 2 percent, to close at $5.81.
Keith Darce: (619) 293-1020; keith.darce@uniontrib.com. Follow on Twitter @keithdarce
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