Genzyme Corporation announced its market launch of a new rapid test that will aid in the diagnosis of bacterial vaginosis (BV), the most common cause of vaginitis/vaginosis in women, informed a release.
The OSOM BVBLUE Test provides reagent, sample swabs and testing vessels in this ten minute, user-friendly kit. Once a vaginal swab is added to the testing vessel, a drop of developer solution turns the solution a blue or green colour if the sample is positive for BV.
This product launch comes only a few months after Genzyme received clearance from the US Food and Drug Administration to market a rapid test that aids in the diagnosis of trichomonas infection - a frequent cause of vaginitis/vaginosis, and the most common, non-viral sexually transmitted disease in the world.
Both tests, the OSOM Trichomonas Rapid Test launched this past spring, and this new bacterial vaginosis rapid test, detect pathogenic antigens directly from vaginal swabs. Results for both tests are rapid, occurring within approximately 10 minutes.
"We are very excited about bringing the OSOM BVBLUE Test to market," stated Don Pogorzelski, president of Genzyme Diagnostics. He added, "The rapid time to result of this test will provide greater accuracy and patient convenience, and assist physicians in diagnosing and determining appropriate treatment for patients in a single office visit."
Genzyme will market its OSOM BVBLUE Test along with the OSOM Trichomonas Rapid Test.
Both of these point-of-care tests are useful to sites providing women's health diagnosis and treatment, including hospital emergency room physicians, OB/GYN physicians, public health labs, STD clinics, reference labs, and other sites that perform STD testing. The use of these two tests will help physicians to diagnose two common causes of vulvo/vaginal symptoms. There are an estimated 10 million office visits each year by women exhibiting symptoms consistent with vaginitis/vaginosis.
Genzyme Diagnostics is a major supplier of diagnostic tests with a focus on infectious diseases, diabetes, and cardiovascular disease. It specializes in point-of-care tests, performed in the doctor's office or hospital. Genzyme Diagnostics is a business unit of Genzyme Corporation, the release says.