Sequenom Gets FDA Clearance For IMPACT Dx System - Quick Facts

(RTTNews) - Sequenom, Inc. (SQNM) announced Monday that it has received premarket 510(k) clearance from the United States Food and Drug Administration (FDA) to market its IMPACT Dx Factor V Leiden and Factor II Genotyping Test and the IMPACT Dx System.

The IMPACT Dx Factor V Leiden and Factor II Genotyping Test is performed on the IMPACT Dx System, and is indicated for use as an aid in the diagnosis of patients with suspected thrombophilia.

As previously indicated, Sequenom completed the sale of its Bioscience business segment to Agena Bioscience. As part of this sale, the Premarket 510(k) Notification will transfer to Agena Bioscience and Sequenom will receive $2 million upon the achievement of this regulatory milestone.

In separate press release, Sequenom and Quest Diagnostics (DGX) announced an agreement under which Quest will offer national access to Sequenom Laboratories' MaterniT21 PLUS laboratory-developed test (LDT). Using a maternal blood sample, the noninvasive prenatal test (NIPT) analyzes chromosomal material in cell-free fetal DNA of pregnant women at increased risk for fetal chromosomal abnormalities. Quest expects to begin offering access to the test in the third quarter.

In addition, Quest has formed a license agreement with Sequenom for certain NIPT patents and patent applications. The license agreement is the first formed by Sequenom with a commercial lab in the United States. Quest intends to use the intellectual property for the purposes of developing and validating its own proprietary lab-developed NIPT test. Quest expects to introduce this new offering in 2015. Additional terms of the agreement were not disclosed.