We’ve all no doubt heard of numerous applications from med-tech companies that can stop the spread of methicillin-resistant Staphylococcus aureus (MRSA), a strain of lethal bacterial infection that garnered heavy media attention during the latter part of 2007. The most recent product that comes to mind is Acrymed’s (Portland) SilvaGard, an application comprised of nanoparticles with silver that can arrest the spread of such bacteria.
But what about a test that can quickly diagnosis infection from this bacteria?
BD (Franklin Lakes, New Jersey) now can claim that, the company reporting yesterday that it has received FDA clearance for its GeneOhm StaphSR assay, an advanced test derived from a previous assay developed by its GeneOhm (San Diego) subsidiary.
BD says that this test is the first available to rapidly and simultaneously identify two deadly healthcare-associated infections (HAIs) — Staphylococcus aureus (SA) and MRSA, from patients with positive blood cultures and that it can produce results in two hours.
“Getting fast results was a very important factor when it came to developing this test,” Barbara Kalavik, of BD’s public relations staff, told Medical Device Daily. “Previous tests took anywhere from 24 hours to two days to confirm if a patient had MRSA. That’s entirely too long.”
FDA cleared the BD GeneOhm StaphSR assay based on the results of a clinical trial at five locations. The new assay identified 100% of the MRSA -positive specimens and more than 98% of the more common, less dangerous staph specimens. The test was given CE mark status in April of last year.
The BD GeneOhm StaphSR Assay looks at the molecular composition of blood and identifies whether the sample contains genetic material from the MRSA bacterium or the more common, less dangerous staph bacterium that can still be treated with methicillin.
In order to preserve the integrity of positive test results, this test should be used only in patients suspected of a staph infection, according a release from FDA. The test should not be used to monitor treatment for staph infections because it cannot quantify a patient’s response to treatment.
The agency said that the test results should not be used as the sole basis for diagnosis as they may reflect the bacteria’s presence in patients who have been successfully treated for staph infections. Also, the test will not rule out other complicating conditions or infections.
“The launch of the BD GeneOhm StaphSR assay in the United States further demonstrates BD’s commitment to helping healthcare providers rapidly identify, prevent and control HAIs,” said Vince Forlenza, executive VP of BD. “It also illustrates our desire to provide customers with a complete menu of assays and tools to combat these potentially deadly infections.”
It will help enable physicians to implement the right treatment at the right time for patients with bloodstream infections, thereby transforming patient care and significantly reducing healthcare costs. It is easy to perform and requires less technologist time than traditional microbiology algorithms, which can take two days to generate results. Studies have shown that providing physicians with critical microbiology information earlier will result in decreased mortality, length of stay and variable costs.
“The BD GeneOhm test is good news for the public health community. Rather than waiting more than two days for test results, healthcare personnel will be able to identify the source of a staph infection in only two hours, allowing for more effective diagnosis and treatment,” said Daniel Schultz, MD, director of the FDA’s Center for Devices and Radiological Health.
Staph infections occur most frequently among persons in hospitals and healthcare facilities (such as nursing homes and dialysis centers) who have weakened immune systems. Both types of bacteria also can infect healthy people.
Distinguishing between the two sources of infection is critical to successful treatment. The more common, less dangerous strain of staph results in infections that are generally mild and affect the skin with pimples or boils that can be swollen, painful and drain pus.
However, the MRSA staph bacterium is difficult to treat with ordinary antibiotics. It can cause potentially life-threatening conditions such as blood stream infections, surgical site infections or pneumonia.
Currently, the BD GeneOhm MRSA assay rapidly identifies patients who are colonized with MRSA and allows infection control professionals to break the chain of MRSA transmission. BD said it recently submitted additional applications to the FDA for the BD GeneOhm StaphSR assay to add nasal swab and wound claims. BD is also developing rapid tests for the detection of two other organisms that cause severe HAIs. These tests will identify the vanA and vanB genes associated with vancomycin-resistant enterococci and the toxin gene associated with Clostridium difficile. These rapid assays will further complement the company’s portfolio of HAI-related products.
BD has been rolling along with strong profits and on an upward acquisition path as of late.
Late last year it reported record quarterly revenues of $1.651 billion for 4Q07, an increase of about 13% over the year-ago quarter (Medical Device Daily, Nov. 2, 2007) The company said that the quarter’s growth rate reflected the favorable impact on all segments from foreign currency translation, which overall is estimated to account for three percentage points of the increase in quarterly revenues.
BD completed its $230 million acquisition of GeneOhm Sciences in February 2006 (MDD, Feb. 15, 2006). GeneOhm develops molecular diagnostic testing for the rapid detection of bacterial organisms, including those known to cause healthcare-associated infections.
BD also finalized its $350 million acquisition of TriPath Imaging (Burlington, North Carolina) last month (MDD, Dec. 21, 2006). TriPath makes products intended to improve the clinical management of cancer.