A collaboration between Response Biomedical (Burnaby, British Columbia) and 3M (Minneapolis) established last December to develop tests for infectious disease may have its first product on the market by the 2007-2008 flu season.
Response Biomedical reported earlier this week that it had filed a 510(k) submission seeking clearance to market a rapid influenza A+B test conducted at the point of care, meaning it is expected to detect both influenza types A and B. Influenza A is the most common type of influenza infection and usually causes the most serious epidemics, the company said.
“The main reason [for a POC test] is being able to make a decision quickly for the patient, so when patients present themselves to the emergency room [to enable a healthcare provider] to be able to make a diagnosis right away, rather than waiting for several days for a culture to come back,” Paul Casey, alliance manager for Response Biomedical, told Medical Device Daily.
The goal for the test is to enable physicians “to be able to either treat them or make a clinical decision based on the presence or absence of flu,” he said.
And because avian flu is a type A influenza virus, the POC test is also expected to be able to detect avian flu, although it would not be able to differentiate it as such – much like most other diagnostic products for flu currently on the market, Casey said.
The real differentiator for the Response/3M product is the use of Response’s RAMP technology platform, which consists of a portable fluorescent reader and single-use disposable test cartridges. According to Response Biomedical, this diagnostic platform “delivers highly sensitive reliable results in less than 15 minutes.” The company also says that the RAMP platform has the potential to be applied to more than 250 medical and non-medical tests currently performed in laboratories.
Unlike others POC tests that are “visually read,” the RAMP reader is “an objective measure of positive or negative, and it’s also connected into the lab information systems,” Casey said.
Although clinical studies conducted on the new flu A+B test have shown equivalence with another product currently on the market, Casey said he could not discuss the data while the company’s submission is under review at the FDA.
The flu A+B test is the first submission coming as a result of the collaboration between Response Biomedical and 3M.
The companies reported in December that they had entered into a worldwide, exclusive agreement with 3M through its medical division to “pursue the development and commercialization of diagnostic products targeting hospital and community-acquired infectious diseases” using Response’s RAMP testing platform.
As part of the collaboration, 3M made an $8 million equity investment in Response Biomedical, which represents about a 13% ownership position. Under the agreement, Response Biomedical is responsible for test development, while 3M is responsible for all clinical and regulatory activities, as well as having responsibility for all sales and marketing efforts.
“This is a tremendous opportunity to collaborate with a world leader in infection prevention,” Bill Radvak, Response Biomedical CEO, said at the time. “Expanding our relationship with 3M Medical Division, which began in November 2004, is an important step in our strategic vision.”
Radvak also said that his company’s plan was to partner commercialization efforts with “companies that have the sales and marketing expertise and infrastructure to leverage the competitive advantages of the RAMP platform.”
He added that the investment would allow Response to put resources into its cardiovascular programs.
The 3M collaboration also includes plans for a Staphylococcus aureus (S. aureus) test, in addition to the flu test.
Among Response Biomedical’s plans are to launch its NT-proBNP congestive heart failure test in the U.S., where studies for FDA submission began in November. That test began selling in Europe in January (MDD, Jan. 29, 2007) and the company received approval in Canada this week. The NT-proBNP test was licensed from Roche Diagnostics (Indianapolis).
In February, Response Biomedical reported that as part of a succession plan, Radvak will step down as president/CEO following conclusion of an executive search for a replacement (MDD, Feb. 7, 2007).
Response also has FDA and Health Canada market clearance of the RAMP Reader and tests for troponin I, myoglobin and CK-MB. The company also has commercially available rapid biodefense tests for bioterror agents such as anthrax, ricin, smallpox and botulinum toxin and counts the United Nations, U.S. Army and other U.S. military branches among its customers.