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Sequenom Signs NIPT Deal with Quest; Gets FDA Clearance for Impact Dx System, Thrombophilia Test

NEW YORK (GenomeWeb) – Sequenom and Quest Diagnostics today announced a deal for Quest to offer the MaterniT21 Plus non-invasive prenatal test nationally. Sequenom also announced that the US Food and Drug Administration has issued 510(k) premarket clearance of the firm's Impact Dx system and Impact Dx Factor V Leiden and Factor II Genotyping test.

Quest expects to begin offering the MaterniT21 Plus test during the third quarter. Calling non-invasive prenatal testing "one of the most promising new areas of medicine," Quest Senior Medical Director of Genetics Charles Strom said that providing access to Sequenom's test "strongly aligns with our strategy to deliver guideline-based testing services based on the most advanced technologies in order to improve healthcare for patients."

MaterniT21 Plus measures the relative amount of trisomy 21, 18, 13, and other chromosomal material and micro-deletions and duplications in cell-free DNA from maternal blood samples. As a result of today's deal, physicians will be able to order the test through Quest, which will forward specimens to Sequenom Laboratories.

Quest has also formed a licensing agreement with Sequenom for certain NIPT patents and patent applications for developing and validating its own proprietary laboratory-developed NIPT test, which Quest anticipates offering in 2015.

Financial and other terms of the agreement were not disclosed.

Also, Sequenom announced the FDA clearance of the Impact platform and the Factor V Leiden and Factor II Genotyping test performed on the system. The test is indicated for use as an aid in diagnosing patients with suspected thrombophilia.

Sequenom is transferring the 510(k) clearance to Agena Bioscience as part of the $31.8 million sale of Sequenom's bioscience business to the San Diego-based portfolio company of investment firm Telegraph Hill Partners. Sequenom will receive a $2 million milestone payment as a result.

In a statement, Agena Chairman and Interim CEO John Lillig said the clearance "contributes significant value to our business and represents the transition of our proven research-use-only MassArray system into the clinical diagnostics arena."