Sequenom Disputes FDA Letter on Genetic TestSequenom Disputes FDA Letter on Genetic Test

San Diego-based Sequenom says it is disputing a recent FDA untitled letter seeking regulatory approval or clearance of the company’s genetic test. FDA’s letter is part of a recent crackdown on so-called laboratory-developed tests (LDTs) under which the agency asserts approval authority over devices that are more commercial in nature.

According to FDA’s letter in July, it had come to the agency's attention that Sequenom was marketing without approval or clearance its SEQureDx, “a prenatal genetic diagnostic technology, intended to enable the detection and analysis of circulating cell-free fetal (ccff) nucleic acids (RNA or DNA) in a pregnant woman's blood sample for fetal gene and chromosome abnormalities." It further says that if the company does not believe the test requires clearance or approval then it should provide the agency “with the basis for that determination.”

Sequenom said in a July 27 SEC filing that it believed FDA’s letter referred to its SensiGene Fetal Rhesus D Genotyping test, “which is our first laboratory-developed test (LDT) powered by our SEQureDx technology. This test is designed to detect ccff DNA from maternal blood and examine multiple regions of the gene that are known to be the most common genetic basis of Rhesus D negative phenotypes. The test was developed and validated by our laboratory — the Sequenom Center for Molecular Medicine (Sequenom CMM). We believe that the test meets the definition of an LDT. 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. Rather, samples are ordered by a physician, collected and sent to Sequenom CMM for testing, and the results are reported back to the physician.”

The company said it was preparing a response to FDA's letter and planned to discuss the matter with the agency in the near future.