Roche plans to make a rapid antigen test for the novel coronavirus widely available in Europe later this month, while also submitting it to FDA reviewers for an emergency authorization in the U.S.
The point-of-care diagnostic aims to provide a result within 15 minutes, as a way to screen people with or without symptoms for COVID-19.
The Big Pharma said it will start off with 40 million tests in stock at launch and plans to ramp up production to more than twice that number, per month, by the end of the year.
“Especially in the upcoming flu season, it is important to know whether a person has SARS-CoV-2 or the flu to ensure the right course of treatment,” Roche Diagnostics CEO Thomas Schinecker said. “COVID-19 testing solutions that provide healthcare professionals and patients with a quick answer regarding their infection status are critical to contain the community-spread of the COVID-19 virus.”
The antigen immunoassay marks the 10th addition to Roche’s COVID-19 test portfolio, supported by a global distribution partnership with the Korean diagnostics manufacturer SD Biosensor. According to Roche, the test has a false-positive rate of less than 1%, and a false-negative rate of about 3.5%, and is designed for deep, nasopharyngeal swabs collected by a healthcare professional.
At the same time, Roche announced that it received FDA approval for a qualitative molecular diagnostic for HIV, combining confirmatory testing of an acute infection while also differentiating between HIV-1 and HIV-2, to help guide the correct treatment.
Both HIV-1 and HIV-2 have the same routes of transmission and can cause the immunodeficiency syndrome known as AIDS. According to Roche, HIV may be transmitted as early as three days from the time of infection, which current antibody-based testing may not detect, as they rely on the human body to generate a strong immune response that may take weeks.
The PCR test was approved for use on Roche’s automated cobas 6800/8800 systems, and aims to reduce the time-to-detection period by at least one week, the company said.