A Diagnostics & Imaging Week
BD Diagnostics (San Diego), a unit of BD (Becton, Dickinson and Co.; Franklin Lakes, New Jersey) reported receiving the CE mark for the BD GeneOhm Cdiff molecular assay for the rapid diagnosis of patients with Clostridium difficile infection (CDI).
The company said it is the first CDI diagnostic test that offers sensitivity, simplicity and speed in one test procedure. BD also has submitted this assay to the FDA for clearance.
CE-marked for the identification of toxigenic C. difficile directly from stool specimens, the BD assay targets the toxin B gene. BD Diagnostics said it is the only CDI diagnostic test that combines high assay sensitivity with a rapid turnaround time of less than two hours.
That facilitates earlier treatment of patients suffering from CDI and earlier implementation of infection control interventions to prevent transmission of Clostridium difficile to other patients.
Until now, rapid diagnosis of CDI has been difficult since traditional methods consist of immunoassays, which lack sufficient sensitivity, and traditional "gold standard" tissue culture cytotoxicity methods require several days to yield results.
"The BD GeneOhm Cdiff assay provides a simple and rapid stool test with excellent sensitivity and specificity that allows same-day identification of toxigenic Clostridium difficile," said Thomas Davis, MD, PhD, professor of pathology and laboratory medicine at Clarian Pathology Laboratory. "This test should improve patient care because it effectively eliminates the need for multiple screening and confirmatory assays, speeds up reporting and helps avoid unnecessary antibiotic use."
In the UK, C. difficile infections have risen 40% in the last three years, infecting eight times as many patients as MRSA and killing twice as many. In the U.S., an estimated 500,000 people are hospitalized annually and more than 28,000 die from CDI. The average length of stay for a CDI patient is nearly three times longer than the average patient and excess healthcare costs exceed $1 billion.
Russian distributor for Spectral
Spectral Diagnostics (Toronto) said it has entered into an exclusive distribution agreement in Russia with BB Medical to distribute Spectral's Endotoxin Activity Assay (EAA), the only FDA-cleared assay for the measurement of endotoxin.
BB Medical will market and sell EAA throughout the Russian Federation.
"BB Medical is a leading distributor of medical technologies in Russia. Their significant market reach in this region will help to strengthen our presence in yet another geographic territory — a key component in the global commercialization strategy for our EAA product," said Dr. Paul Walker, president/CEO of Spectral Diagnostics.
He added, "Our distribution agreement with BB Medical ... is expected to be the first of several distribution agreements in new geographic territories. Ultimately, these alliances will drive the adoption of our unique product globally, both as a stand-alone product, and also in combination with therapeutics for the diagnosis, treatment and monitoring of patients with endotoxemia."
The agreement with BB Medical is a result of the company's expanded collaboration agreement with Toray Medical that was reported in May. Through that accord, Spectral may now access Toray's distributors in other geographic territories, including China, India and Canada.
NIOX Mino approved in China
Aerocrine (Stockholm, Sweden) said its hand-held airway inflammation monitor, NIOX Mino, has been registered for marketing and sale in China.
The company's method of measuring airway inflammation, using exhaled nitric oxide (NO) tests, has also has been incorporated into China's national guidelines for asthma management, and tests for airway inflammation have received a reimbursement code.
In December 2007, NIOX, Aerocrine's larger device, was registered by the Chinese SFDA. Clearance of NIOX Mino means the company's Chinese partner, Bioson, now can begin product sales for broad clinical use by Chinese physicians.
The newly revised Chinese National Guidelines for Asthma Treatment and Prevention state: "... exhaled nitric oxide can be used as a non-invasive marker of airway inflammation in asthma ... measuring airway inflammation is helpful in choosing the best treatment scheme for asthmatic patients."
The guidelines have resulted in a reimbursement code being designated for Aerocrine's method to measure airway inflammation. The company said the code is the first big step toward doctors using NIOX Mino, securing payments per test.