NEW YORK (GenomeWeb News) – GenMark Diagnostics said this week that it has received a medical device manufacturing license for its new Carlsbad, Calif., facility. The firm said that it can now manufacture and distribute all existing and future products from the facility. It also means that GenMark will cease all manufacturing and distribution from its Pasadena, Calif., facility as of the end of March 2011.
Roche this week said that it has acquired PVT Probenverteiltechnik of Waiblingen, Germany, and its US distributor PVT Lab Systems of Atlanta, for up to €85 million ($120.2 million). PVT makes customized automation and workflow solutions, such as pipettes and centrifuges, for in vitro diagnostic testing in commercial and hospital labs. Roche has agreed to pay PVT's shareholders €65 million up front, and another €20 million if certain milestones are met.
Vermillion said that its OVA1 multiplex, proteomic biomarker test, which is used to help physicians assess, prior to surgery, the likelihood that a woman's ovarian mass is malignant, has been included in the recent American College of Obstetricians and Gynecologists/Society of Gynecologic Oncologists committee opinion. The updated opinion cites US Food and Drug Administration clearance of the OVA1 test and indicates that the test "appears to improve the predictability of ovarian cancer in women with pelvic masses," the firm said.