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Sequenom, Inc. Reports Financial Results For The Third Quarter Of 2013
Date:11/7/2013

MaterniT21 PLUS test is able to provide content previously undetected from a maternal blood draw. These results can now present health care providers and their patients with information that may have taken months or years to obtain otherwise.

"The Enhanced Sequencing Series affirms the value of using higher content genome-wide massively parallel sequencing, as opposed to targeted approaches," said Welch. "By using a genome-wide solution, Sequenom Laboratories is positioned to continue to add future meaningful content in an effective, efficient way." 

In September, Sequenom submitted two Premarket 510(k) Notifications for the IMPACT Dx™ System and the IMPACT Dx™ Factor V Leiden and Factor II Genotyping Tests to the U.S. Food and Drug Administration. The IMPACT Dx System is the clinical laboratory version of the Company's MassArray® System. Premarket clearance of the IMPACT Dx System will enable the Company to expand from research use only into clinical diagnostics and is expected to facilitate registration of the IMPACT Dx System in international markets. 

In the third quarter, Sequenom completed its early access program to enable selected customers to complete studies that validated that the ultrasensitive assay on the MassArray System can detect mutations down to 0.1%. This is another important step in the increased utility of the MassArray System. The Company expects to launch additional research-use-only panels in oncology and rare blood antigen typing.

As previously announced, on October 30, 2013, the U.S. District Court for the Northern District of California issued an order finding that the Lo '540 patent (U.S. Patent No. 6,258,540) is invalid. The court found that the '540 patent combines the discovery of a natural phenomenon, the presence of cell-free paternal DNA in the blood of a pregnant woman, with conventional diagnostic methods. The court concluded that the combination of conventional
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