NEW YORK (GenomeWeb News) – The US Food and Drug Administration this week gave 510(k) clearance to Beckman Coulter's Access AccuTnl+3 troponin l assay for use on the company's Access 2 immunoassay system.
In order to gain the long-awaited clearance, Beckman Coulter conducted a prospective clinical trial for the assay that included the enrollment of more than 1,900 subjects, following guidance from FDA in 2010 that manufacturers of troponin assays modernize the performance evaluation and regulatory review of such tests, the company said.
Beckman Coulter's troponin test kits were the source of a regulatory controversy at the firm three years ago that preceded its acquisition by Danaher. In addition to the Access 2 system, Beckman Coulter has a troponin assay that runs on its Dxl instruments, for which it submitted a 510(k) application last June.
In a research note, Goldman Sachs' Isaac Ro said that a lack of FDA clearance for its troponin assays "has been a key impediment to Beckman's growth rate in recent years," and this week's clearance will "now allow Danaher to re-engage the installed base and target renewals for long-term contracts while also seeking to recover lost market share."
The ISI Group's Ross Muken and Vijay Kumar added in a research note that clearance of the assay for the Access 2 platform bodes well for similar clearance of the assay for the Dxl platform.
Siemens Healthcare Diagnostics and Johnson & Johnson's Janssen Pharmaceutica are collaborating to develop and commercialize an immunoassay companion diagnostic test for an early stage compound being developed by Janssen to treat heart failure. The compound targets autoantibodies directed against the human B1-adrenergic receptor. Siemens will work with Janssen to design companion diagnostic tests to be used in Janssen's clinical studies. Siemens Clinical Laboratory — a high complexity testing laboratory whose goal is to advanced personalized medicine — will develop the clinical trial assay, while Siemens will develop and validate an in vitro diagnostic test as a companion diagnostic for the Janssen therapeutic product.
The Association for Molecular Pathology is joining the Federation of American Societies for Experimental Biology on July 1. FASEB represents more than 100,000 individuals through 26 constituent societies with the goal of advancing research and education in biological and biomedical sciences.
The Blue Cross Blue Shield Association has joined the Worldwide Innovative Networking, or WIN, Consortium, which was founded in 2010 to accelerate the pace and reduce the cost of translating novel cancer treatments to the bedside. WIN now has 29 members from the academic, pharmaceutical, biotechnology, healthcare IT, health plan, and patient advocacy sectors.
The Broad Institute has become an early adopter of Agilent Technologies' Encore Multispan liquid-handling system. The system "unites advanced liquid handling and robotic integration for true sample-to analysis automation," Agilent said. It added that Broad "will be the first to take advantage of the capabilities of this pioneering instrument to develop solutions for a variety of high-throughput genomics workflows."
Kurma Life Sciences Partners launched the Kurma Biofund II venture capital fund to invest in life science initiatives aimed at rare diseases. The first closing targets €44 million ($58.1 million). A spokesman said that the fund will invest "at least 25 percent" of its funds into the diagnostic and medtech space, including genomics-related and molecular diagnostics endeavors. An earlier fund, Kurma Biofund I, led the financing round of Stat-Diagnostica, which raised $22.1 million in a Series B financing round recently. Kurma Biofund I also created a molecular diagnostics company called Pathoquest in partnership with the Pasteur Institute. Kurma Biofund II, the spokesman said, plans to follow the model of the earlier fund to invest in innovative diagnostic solutions.
Drop-Tech and Dolomite are collaborating to develop Drop-Tech's RoboDrop technology into the Mitos Dropix droplet-on-demand sampler. The high-throughput screening format is for use in basic research, drug discovery, and diagnostics applications. The Mitos Dropix sampler can create nanoliter droplet sequences from up to 24 different samples and can be used as an add-on for conventional microfluidic chips, Dolomite said.
In Brief This Week is a Friday column containing news items that our readers may have missed during the week.