Hologic joins with Metamark to market prostate cancer test; Cepheid inks molecular Dx distribution deal with Henry Schein

Welcome to Dx Digest, where FierceMedicalDevices highlights the highs and sometimes lows of the past week in the diagnostics industry. Hologic recently struck a deal with cancer diagnostics company Metamark Genetics to market its prostate cancer test. Cepheid announced that it's teaming up with Henry Schein Medical to distribute its testing system and related diagnostics, which cover areas including infectious disease and sexual health. Last but certainly not least, Signal Genetics and MD Anderson are kicking off a new study to see how well Signal's multiple myeloma test can identify patients at risk for their disease worsening. Read on for the details. And as always, feel free to contact us with any comments or questions. -- Emily Wasserman (email | Twitter)

Hologic forges sales pact with Metamark Genetics for prostate cancer Dx

Hologic ($HOLX) has been focused on 3-D mammography lately, targeting sales of new machines to keep its sales climbing. But the company doesn't want to put all its eggs in one basket, and it's exploring other avenues for growth.

In that vein, the Cambridge, MA-based company has selected Metamark Genetics as the exclusive worldwide sales agent of its Progensa PCA3 test, a urine-based assay for noninvasive prostate cancer detection. The test, which runs on Hologic's semi-automated DTS systems, helps reduce repeat biopsies by identifying men who test negative for the disease after they've already had the procedure.

Hologic and Metamark are also planning to develop a second-generation test for early detection of prostate cancer that runs on Hologic's proprietary testing instrument, and Metamark will have the right to sell the test in certain territories, the pair said in a statement. "We very much look forward to leveraging Metamark's proven urological cancer care expertise as we seek to expand our footprint in the field of prostate oncology," Tom West, Hologic's president of Diagnostic Solutions, said in a statement. Statement

Cepheid taps Henry Schein to distribute molecular diagnostics system

Cepheid ($CPHD) has high hopes for 2016, planning to launch its point-of-care diagnostic device, GeneXpert Omni, during the next year. In the meantime, though, the company is focused on beefing up sales for its GeneXpert molecular diagnostics system and has signed on Henry Schein Medical ($HSIC) to help it along the way.

Under the terms of the deal, Henry Schein will bring Cepheid's GeneXpert System to nonacute lab customers in the U.S., which include physician-office labs, women's health clinics, urgent care facilities and student health centers. Up until now, Sunnyvale, CA-based Cepheid has mostly offered its molecular diagnostics system at U.S. hospital labs. A pact with Henry Schein presents an "immediate opportunity" to expand the system's reach, Cepheid CMO Dr. David Persing said in a statement, with 10,000 labs outside the hospital potentially signing on to the product. And that number will only increase after the company rolls out its GeneXpert Omni system this year, Persing said. Release

Signal Genetics joins up with MD Anderson for study of multiple myeloma test

Signal Genetics and MD Anderson Cancer Center are getting the ball rolling on a study of Signal's multiple myeloma test, MyPRS. The pair will look at specimens from 200 patients to see if individuals are at risk of their cancer progressing from asymptomatic to symptomatic multiple myeloma and will also collect next-generation sequencing data to better categorize patients.

"Stratifying patients into risk categories is a crucial step in determining the proper course of treatment and MyPRS has the ability to provide physicians with this vital information," Signal CEO Samuel Riccitelli said in a statement. "We believe this study will provide additional support for the clinical utility of our assay and we look forward to working with MD Anderson as we seek to improve the care of patients suffering from multiple myeloma." More

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