Franklin Lakes, New Jersey-based BD designed the RVP for its BD Max system as a single molecular diagnostic that identifies a number of viruses. It distinguishes SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV) in approximately two hours.
The FDA granted the test emergency use authorization (EUA) in February. It uses a single nasal swab or single nasopharyngeal swab sample to determine if a patient has COVID-19, the flu or RSV. BD says its RVP test helps to eliminate the need for multiple individual tests or doctor visits. It can also help clinicians implement the right treatment plan in a fast and efficient manner.
Co-testing also helps to increase testing capacity during the busy flu season and speed up diagnosis time, BD added.
“Last year, we experienced a threat of a ‘tripledemic’ with COVID, flu and RSV circulating simultaneously, and that threat remains for the coming respiratory season,” said Nikos Pavlidis, VP and GM for diagnostics at BD. “As patient symptoms and clinical presentation can be nearly identical, a combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients, and help manage the spread of the infections.
BD Max, a molecular diagnostic platform, can analyze hundreds of samples over a 24-hour period. The RVP detects and differentiates the RNA of the viruses in approximately two hours with the BD Max. It also enables the automated “walkway workflow” that requires minimal human interaction.
“The advanced robotic architecture of the BD MAX system automates manual, time-intensive processes, which has never been more important than in today’s environment of staffing shortages and laboratory scientist burnout,” Pavlidis added.
Another milestone for BD’s diagnostics business
The past year or so has been a positive one for the diagnostics arm of BD. Dave Hickey, EVP and president of the Life Sciences segment at BD, spoke to MassDevice about how the business is driving greater access to care earlier this year.
In addition to the EUA and now 510(k) clearance for the RVP, the company accomplished a variety of milestones with various diagnostics.
BD received FDA 510(k) clearance for its Vaginal Panel diagnostic on the COR system in March. The comprehensive diagnostic test directly detects the three most common infectious causes of vaginitis. Pavlidis spoke with MassDevice to explain BD’s effort to increase education on sexually transmitted infections and women’s health.
In May, the FDA cleared the company’s new Kiestra imaging application that uses AI. The methicillin-resistant staphylococcus aureus (MRSA) imaging application uses AI to interpret bacterial growth. It releases negative specimens with minimal human interaction.
