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MDx/CDx Focus: Exact Finishes Cologuard Submission; Natural Molecular Launches Cardiac Test on xMAP


Natural Molecular Launches Personalized Rx Cardiac Test on Luminex xMAP

Natural Molecular Testing this week launched the Personalized Medicine Panel, which gauges 42 targets associated with response to cardiac-related treatments using Luminex's xMAP Technology.

As reported by GenomeWeb Daily News, market analysts have speculated that with this new collaboration, Natural Molecular is replacing its existing GenMark instruments with Luminex's platform. If so, this could impact GenMark's business since Natural Molecular is one of GenMark's biggest customers.

Natural Molecular's Beau Fessenden said in a statement that by transitioning to the xMAP platform, the company is able to expand the biomarker panel of the test. Furthermore, with this platform, Natural Molecular hopes to improve throughput and workflow efficiency, and provide a more sensitive assay.

The Personalized Medicine Panel gauges mutations in the following genes: CYP450 2C19, CYP450 2C9, CYP450 2D6, CYP450 3A4, CYP450 3A5, ABCB1, VKORC1, MTHFR, Factor II, Factor V Leiden.

The partners didn't disclose the terms of the multi-year deal and license agreement.

Exact Completes Submission of Final PMA Module for Cologuard

Exact Sciences announced this week that it has submitted data from the DeeP-C pivotal trial involving its Cologuard test to the US Food and Drug Administration.

Exact has taken the parallel review pathway to simultaneously seek FDA approval and Medicare coverage for its stool-based DNA colorectal cancer screening tests. This latest data submission on June 7, represents the final module the company needed to submit to complete is pre-market approval application with the FDA (PGx Reporter 4/24/2013).

Next, Exact will submit information about the test to the Centers for Medicare & Medicaid Services by summer or fall. Also in the fall, an FDA advisory panel is slated to review the DeeP-C data.

The DeeP-C trial involved 10,000 patients at 90 sites between the ages of 50 and 84 who were at average risk for colorectal cancer. Exact will publish the complete data analysis from this study and present it at upcoming medical conferences. If all goes well, the company expects to hear from the FDA about the Cologuard PMA early next year, and CMS will likely issue its coverage determination around the same time.

Once launched, Exact's Chief Operating Officer Maneesh Arora will handle US sales and marketing for Cologuard. The company is in the process of building its commercial leadership team and is seeking to hire a senior financial officer.