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Herpes Testing

FDA Approves Roche HSV Test

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In September Roche Diagnostics announced the FDA green-lighted the company’s blood antibody tests for HSV-1 and HSV-2, respectively.

The tests join other “type specific” HSV blood assays on the market that are able to detect the HSV-specific IgG antibody and accurately distinguish HSV-1 antibodies from those of HSV-2. Older, non-specific HSV tests remain available but experts don’t recommend their use.

Viral culture - where a swab of the genital area is taken and the virus is detected in a lab- is another method of diagnosing HSV. This is tricky when no symptoms are present, so for many a blood test is the most practical means of determining their HSV status. (Fewer clinics are offering viral culture, too.) Given that HSV-2 seldom infects other areas of the body, a positive HSV-2 blood test is assumed to reflect a genital infection.

Read more about HSV blood tests at ASHA.


Two Companies Making Big Strides for HSV

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The new year is already bringing some welcomes news for HSV and it is just getting started. On January 3rd two companies, Becton, Dickinson and Company (BD) and Genocea Biosciences made important announcements regarding what they are doing for HSV.

Genocea Biosciences, a vaccine discovery and development entity, got a major boost when they secured $35 million Series B venture financing. The priority for the company is to target infectious diseases that have significant unmet medical needs. New investors that came with this deal were Johnson and Johnson Development Corporation Skyline Venture and MP Healthcare Venture Management. This is welcomed news for HSV because funding will support the company as it enters clinical development for its lead program, a therapeutic vaccine for herpes simplex virus type 2 infections.

On the same day Genocea released their announcement, BD announced their filing for 501k clearance for an automated molecular test to diagnose and differentiate between HSV-1 and HSresearchersV-2. Why the push to develop an automated test? Because as the company states “Data suggest that laboratories using existing culture methods to diagnose HSV often experience significant false negative rates, missing up to 25 percent of true positive cases. In addition, many clinicians and laboratories do not distinguish between HSV-1 and HSV-2.” Their test hopes to address these issues and it promises to do it in significantly less time.

Currently, the widely available method to diagnose herpes is via culture. Culture test are performed by taking a sample of the infected area and put in a tissue culture. Once cell changes occur the lab performs additional test to determine HSV infection. PCR test, polymerase chain reaction test, operates by making multiple copies of viral DNA in order to determine HSV infection. While both methods are used in many labs, PCR has been noted as being more accurate but not as widely available as the culture. However, with the advances BD has made with their automated test this could possibly change and also could bring more standardization to gene amplified testing among labs that perform this test.

Additionally, instead of days or weeks to get culture results, BD asserts that their automated test will be able to read close to 100 positive or negative results in less than three hours. The system that the test will run on will also have the ability to multitask i.e. the system will be able to run not only run the test for HSV-1 and HSV-2 on a single run but it will be also able to run chlamydia and gonorrhea test at the same time.


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