FDA Clears BD's C. Difficile Test as IVD
Becton Dickinson unit BD Diagnostics said this week that it has received 510(k) clearance from the US Food and Drug Administration to sell its molecular diagnostic test to identify the bacterium Clostridium difficile in the US.
The company's GeneOhm Cdiff diagnostic is a rapid stool test to identify the bug's Toxin B gene, which is found in toxigenic C. difficile bacteria.
"This test should improve patient care because it gives labs the option of a single assay that will markedly reduce or even eliminate the need for multiple screening and confirmatory tests," said Thomas Davis, who is a professor at Indiana University's School of Medicine and a pathologist at Wishard Health Services and Clarian Health.
"This would speed up reporting and help avoid unnecessary antibiotic use," Davis added.
An estimated 500,000 people in the US are infected with CDI each year, and over 28,000 of those die, the company said.
According to a survey by the Association for Professionals in Infection Control and Epidemiology, as many as 13 out of every 1,000 hospitalized patients are infected with CDI, and these infections may lead to $1 billion in excess healthcare costs in the US each year.
Exact Rejects Sequenom Acquisition Bid
Exact Sciences said this week that its board of directors has rejected a bid from Sequenom to buy the company for $1.50 per share in Sequenom common stock.
Exact said that the board agreed unanimously to rebuff Sequenom's proposed acquisition, and that the company is "actively pursuing a strategic alternative" that could offer greater value for shareholders than the Sequenom offer.
That offer, which Sequenom advanced after the market close on Friday, was for a stock-for-stock transaction valued at $41 million. Sequenom's shares closed at $23.02 on Friday and dipped more than percent to close at $22.29 late Monday.
The purchase would have been a 69 percent premium to Exact Sciences' close on Jan. 8 of $.89 a share. That price swelled 52 percent today on the news of the offer to close at $1.50 a share.
XDx Inks PGx Collaboration with Bristol-Myers for Lupus
XDx said last week that it has signed a pharmacogenomics pact with Bristol-Myers Squibb to identify biomarkers that would be used for diagnostic purposes in the development of a drug for systemic lupus erythematosus.
XDx is developing non-invasive gene expression tests for monitoring immune-mediated conditions. Bristol-Myers will make an upfront payment to XDx and additional milestone payments based on the achievement of specific R&D objectives. Brisbane, Calif.-based XDx also gets commercial rights to certain diagnostic applications that result from the collaboration.
The firms will be working on tests to monitor the effectiveness of Bristol-Myers' rheumatoid arthritis drug abatacept (Orencia) in treating lupus.
Further terms of the collaboration were not disclosed.
Illumina to Seek FDA OK for MDx System This Year
Illumina hopes to receive US Food and Drug Administration clearance of its BeadXpress system for molecular diagnostic applications in the second half of 2009, President and CEO Jay Flatley said this week at the JPMorgan Healthcare Conference in San Francisco.
Flatley said that the firm would initially target blood typing, pharmacogenomics, and pre-natal testing as the primary applications for the system. Illumina also intends to sign up partners to develop assays for the BeadXpress system, as well as work on diagnostic applications for its Avantome technology.
Partnering is one part of Illumina's three-prong strategy for the molecular diagnostics market, which is currently estimated at around $2.5 billion but is growing rapidly. The other two parts of its strategy include establishing its own CLIA-certified lab and efforts to discover oncology markers for use in MDx tests.
Flatley reiterated previous comments from Illumina officials that the company intends to file for regulatory approval of its CLIA lab during the second quarter of 2009, and expects the lab to be operational sometime during the second half of this year.
The firm's efforts in oncology will first focus on ovarian and gastric cancer, he noted.
According to Flatley, Illumina is working on improving sample preparation for better automation and reliability in diagnostic applications.
He also noted that the company expects to report some molecular diagnostic revenues in 2010, but such revenues "won't move the needle." Such revenues are also far off from overtaking revenues from research applications as the majority of Illumina's turnover, he said.
— by Edward Winnick, GenomeWeb Daily News Managing Editor
Beckman Coulter Expects 2011 Launch for MDx System
Beckman Coulter expects to launch its new molecular diagnostics platform in 2011 instead of its initial target of 2010, Chairman, President, and CEO Scott Garrett said this week at the JPMorgan Healthcare Conference held in San Francisco.
Garrett told investors that a prototype of the fully automated, sample-to-result system, called the UniCel DxN, has been completed. The firm expects to continue developing assays for the system and to seek regulatory approval starting in 2010, with a full commercial launch scheduled for 2011.
The firm had been targeting a 2010 launch date as of the end of 2007. However, Garrett said today that although it is important to get to the market quickly with the system, it is more important that Beckman Coulter "establish a state-of-the-art system for hospitals."
The initial menu for the DxN system will focus on infectious diseases, with content coming from the firm's GeneOhm Sciences business, which focuses on hospital-acquired infections. It also will gain content from collaborations with academic partners, such as Johns Hopkins University and the National University of Ireland, Galway.
Garrett reiterated previous comments that the initial focus on infectious diseases will be followed by tests for cancer and genetic diseases. He said that the firm is likely to have a "handful" of assays available for the DxN at the time of launch.
The system will have as many as 20 tests on board, he said, and will offer results in about an hour. The DxN will be capable of running around 200 tests over an 8-hour shift.
— by Edward Winnick, GenomeWeb Daily News Managing Editor