FDA OKs virus test developed in Balto. Co.

One of the latest coronavirus tests to earn tentative FDA approval was developed in Baltimore County by scientists at biotechnology company Becton Dickinson.

The company said Friday the Food and Drug Administration gave “emergency use authorization” for a test its Sparks-based unit BD Integrated Diagnostic Solutions worked on with BioGX, an Alabama biotech company.

The test runs on a system already in place in 600 hospitals and other labs across the country, used to test for sexually transmitted infections, enteric bacteria and parasites, and hospital-borne pathogens. It will allow those hospitals to use the systems, known as BD MAX, to also detect the virus causing COVID-19 infections, providing results in two or three hours without the need to send samples to outside labs, company officials said.

A research and development team at BD’s Baltimore County facilities was “instrumental” in developing the test, said Dave Hickey, president of diagnostic systems at BD. And the tests are being manufactured at the company’s Sparks campus. BD employs about 1,700 people in Sparks and Hunt Valley, Hickey said.

Hickey said the company expects to distribute as many as 900,000 of the tests a month.

The FDA is allowing the test to be used as long as the coronavirus pandemic remains a national emergency, but has not formally approved it. BD, working with partner companies in China and Europe, has sold similar tests used in outbreaks in those areas.

Under similar emergency approval, BD and North Carolina-based BioMedomics also launched a blood test that can detect whether a patient has developed an immune response, and potentially immunity, to the coronavirus. Known as serology tests, they are expected to be key when the country eventually relaxes social distancing rules that have been ordered to slow the coronavirus pandemic.

A sales and marketing team at BD’s Sparks campus will work to promote that test, Hickey said.