BD Diagnostics, a wing of Becton, Dickinson and Company (BDX), recently filed for 510(k) clearance with the U.S. Food and Drug Administration (“FDA”) for its first completely automated molecular tests to diagnose Herpes Simplex Viruses (HSV) types 1 and 2, which are among the most regular sexually transmitted infections in the globe.   

According to the company, the tests will aid medical practitioners decide if a patient has HSV, and if it is type 1 or 2, which has a major impact on how the infection is treated. This is particularly important given the growth in new anti-viral and exploitive therapies.

The BD ProbeTec HSV-1 and HSV-2 Amplfied DNA Assays will operate on its Viper System. This know-how utilizes Strand Displacement Amplification technology to both identify and differentiate HSV-1 from HSV-2.

It is believed that laboratories utilizing existing culture processes fail to detect up to 25% of true positive cases. Furthermore, many labs are unable to differentiate between HSV-1 and HSV-2.

The latest BD ProbeTec HSV-1 and HSV-2 Assays are expected to sharply improve with respect to both accuracy and timeliness compared to traditional culture methods. Culture methods generally take 2-10 days for results. The company’s HSV assays will permit labs read up to 96% positive or negative outcomes in approximately 2 hours and 30 minutes. Its Viper System can also be used by labs for testing for chlamydia and gonorrhea, besides HSV-1 and HSV-2, on a solo automated run.       

Becton, Dickinson and Company, a leading global medical technology company, produces and markets medical devices, instrument systems and reagents. The company is dedicated to enhancing drug delivery, improving the pace of diagnosing infectious diseases and cancer and advancing R&D for new drugs.

The company competes with companies such as Baxter International (BAX) among others. Becton currently retains a Zacks #3 Rank (a short-term ‘Hold’ rating).

 
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