A global company has had its third test cleared by the U.S. Food and Drug Administration which this month approved GenePOC’s Strep A assay, which provides in vitro diagnosis of Strep A infections within an hour.
According to a press release issued by Gene POC on March 21, Group A streptococcus (GAS) is the most common bacterial cause of sore throats, affecting up to a third of children and a fifth of adults who are afflicted, totaling 11,000 to 13,000 cases annually.
However, sore throats can have many other causes — 70 percent of them viral — and the symptoms of a strep throat can be similar to those of other conditions, ranging from mild viruses to mononucleosis.
This presents a dilemma for physicians, as, according to a study by Dr. Abdu A. Sharkawy, assistant professor of medicine at the University of Toronto, “Accurate and rapid diagnosis of GA Strep is important as there is a possibility that throat and skin infections could lead to severe life-threatening invasive conditions as well as post infection immune mediated complications if left untreated.”
Coupled with the fact that in the U.S. millions of people with sore throats are treated in emergency rooms, the need for speedy assessment is obvious. Yet until recently most tests for strep bacteria took up to 48 hours and, Sharkawy points out, “It may not always be feasible for the patient to return to the clinic and get appropriate treatment based on test results or while waiting for test results there is a possibility that the patient’s symptoms may worsen.”
Because of that dangerous time lag, doctors often start people with suspicious-seeming sore throats on an immediate program of antibiotics as a preventive measure. This of course leads to overuse of antibiotics in people who turn out not to have bacterial infections.
“It may not always be feasible for the patient to return to the clinic and get appropriate treatment based on test results or while waiting for test results there is a possibility that the patient’s symptoms may worsen.”
With the GenePOC assay, however, physicians can obtain reliable “actionable” results without having to wait for 48 hours as in previous tests that relied on cultures.
GenePOC Inc. is a member of the Debiopharm Group.
