Trends & Perspectives
FDA scrutinizes DTC genetic tests
In March, FDA’s Molecular and Clinical Genetics Panel held a meeting to discuss and make recommendations on scientific issues concerning direct-to-consumer (DTC) genetic tests that make medical claims. FDA opened the meeting with a presentation outlining the history and landscape of DTC clinical genetic tests. FDA ended its introductory presentation by providing the current challenges and rationale for the meeting: to hear perspectives from broad panels of experts, invited...
Gen-Probe: Seeking Buyer?
Industry observers and Wall Street traders alike have taken a keen interest in Gen-Probe’s activities and investor announcements this quarter. The interest began in late April, when a news item on Bloomberg’s Web site reported that Gen-Probe had hired financial giant Morgan Stanley to find it a buyer. The Bloomberg story cited “three people with knowledge of the sale,” who were not identified by name, as sources. In response, Gen-Probe’s shares jumped around 13...
Thermo Fisher Scientific buying and selling
In a move consistent with its busy acquisition history in 2010, Thermo Fisher Scientific (TFS) announced at the end of last year its plans to acquire chromatography-system manufacturer Dionex Corp. (Sunnyvale, CA). TFS has also recently completed its sale of Athena Diagnostics and Lancaster Laboratories, two laboratory-testing-services businesses. Proposed Dionex Purchase. As of April 4 of this year, TFS had extended its cash tender offer to 7:00 p.m. EST on May 13. The proposed acquisition...
Lukewarm Response to FDA’s Proposed Innovation Pathway
Reactions to FDA’s proposed Innovation Pathway, part of its new Medical Device Innovation Initiative, are mixed. The Innovation Pathway, if instituted, will be a “priority program for new, breakthrough medical devices,” according to FDA. It is one component of a broader effort by CDRH to “encourage cutting-edge technologies among medical device manufacturers.” The first product submission for this review program is a robotic prosthetic arm being developed by DARPA...
Goldman Sachs initiates coverage of IVD companies
Investment banking firm Goldman Sachs (New York) has initiated coverage on the following six IVD companies: Alere, Cepheid, Gen-Probe, Hologic, Myriad Genetics, and Qiagen. In an equity research report, Goldman Sachs analysts discussed various factors that will affect the IVD industry both positively and negatively. According to the analysts, one of the factors that will contribute positively is the transition to molecular testing. “Advances in knowledge around the genetic underpinnings...
Patent Reform To Benefit IVD Industry
In March, the U.S. Senate voted overwhelmingly to approve legislation to make the first reforms to the U.S. patent system in nearly six decades. The America Invents Act (S. 23) is the product of nearly six years of debate in Congress. The bill was sponsored by Senators Patrick Leahy (D-VT), Orrin Hatch (R-UT), and Chuck Grassley (R-IA), and was cosponsored by a dozen other Senators. “Innovation has always been a catalyzing force in Minnesota and across the United States,” Senator...
Thermo Fisher Scientific Continues Its Acquisition Trend
In a move consistent with its busy acquisition history in 2010, Thermo Fisher announced at the end of last year its plans to acquire chromatography-system manufacturer Dionex Corp. (Sunnyvale, CA). The proposed acquisition comes as the most recent in a string of acquisitions, mostly of companies integrated into Thermo Fisher’s Analytical Technologies segment. Dionex will be brought into the same group; however, unlike the other other three 2010 additions to that division, Dionex...
Cepheid earns WHO endorsement of rapid TB test
Cepheid’s Xpert MTB/RIF test won the endorsement of the World Health Organization (WHO) last December. The test has the potential to revolutionize TB care and treatment by accurately diagnosing patients in about 100 minutes—a huge reduction in time to results compared to conventional TB diagnosis, a WHO representative said in a press statement. Cepheid (Sunnyvale, CA) is offering a 75% discount on the price of the test and the table-top computer system that goes with it to...
Congress Passes Food Safety Law
At the end of last year, Congress passed the FDA Food Safety Modernization Act, which will overhaul the U.S. food safety system and provide better protection against contaminated food and food-borne illnesses. President Obama eventually signed the act into law in early January.     This new food safety legislation proposes to do the following: •    Improve the prevention of food contamination through the identification of hazards before food becomes...
Danaher Acquires Beckman Coulter
Beckman Coulter Inc. (Brea, CA) and Danaher Corp. (Washington, DC) have entered into a definitive merger agreement under which Danaher will acquire all of Beckman’s outstanding common stock for $83.50 per share in cash (without interest), representing an approximate 45% premium over the closing price of Beckman’s common stock on December 9, 2010 before rumors of an acquisition entered the marketplace. The transaction is valued at approximately $6.8 billion, including debt assumed...