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Sequenom Preparing Response to FDA on Warning Letter

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Sequenom today said it will be responding to a warning letter recently received from the US Food and Drug Administration, which claimed that the company is marketing an unapproved genetic test.

In a document filed with the US Securities and Exchange Commission, Sequenom said that it received the FDA letter on July 19 saying that the company was improperly marketing the SEQureDx prenatal genetic diagnostic test. Sequenom said that it believes FDA is referring to the company's SensiGene Fetal Rhesus D Genotyping test, "which is our first laboratory developed test powered by our SEQureDx technology."

The SensiGene test is used to detect circulating cell-free fetal DNA from maternal blood and to investigate multiple regions of the gene known to be the most common genetic basis for Rhesus D negative phenotypes.

While the FDA accuses Sequenom of selling the test improperly, the company said in its SEC document that the test was developed and validated by its laboratory, the Sequenom Center for Molecular Medicine, therefore meeting the definition of an LDT. The company further suggests that the SensiGene test, as a result is not subject to FDA regulation — at least for now.

"The test is solely for use within our CLIA-certified and CAP-accredited laboratory, Sequenom CMM, and is not sold directly to the general public," the company said. "Rather, samples are ordered by a physician, collected and sent to Sequenom CMM for testing, and the results are reported back to the physician."

Sequenom is now preparing a response to FDA's letter "and we look forward to discussing this matter with the FDA in the near future," it added.

A number of high-profile missteps and problems with some genetic tests in recent months has put the FDA on alert, and the agency is now mulling over what role it needs to take in regulating such tests. Earlier this month, FDA sent a batch of letters to 14 companies, including Sequenom, warning them that tests they are marketing require, but have not received, 510(k) clearance or pre-market approval from the regulatory agency as medical devices. The letters followed on similar letters sent last month to 23andMe, Decode Genetics, Navigenics, and Illumina.

While Sequenom said in its SEC document that the SensiGene test is an LDT and outside of FDA's purview, that may change. Last week, FDA held a two-day meeting to discuss how it plans on regulating all LDTs. Though no decision was made by the agency on how it will proceed moving forward, it left open the possibility that tests such as Sequenom's, even if they are LDTs, will soon need FDA clearance.