FRANKLIN LAKES, NJ & LOS ANGELES—Becton, Dickinson and Company (BD) and Scanwell Health, a company focusing on smartphone-enabled at-home medical tests, have announced a collaboration for an at-home rapid test for detecting SARS-CoV-2. The companies plan to create this test by combining an antigen test from BD with the Scanwell Health mobile app technology.
As part of the collaboration, BD will produce a lateral flow antigen test, for pairing with the Scanwell Health mobile app. The app is expected to provide step-by-step instructions on collecting and transferring a nasal swab sample. It will use the mobile device’s camera to analyze and interpret results, and the test result will be displayed onscreen.
“Testing at home before going out into the public is a critical safeguard to help stop the spread of COVID-19,” stated Dave Hickey, president of Life Sciences at BD. “BD and Scanwell Health are bringing the best of our innovations together to develop a reliable test with a convenient and simple user experience. We see the development of an at-home lateral flow rapid antigen test as a complementary solution to our best-in-class BD Veritor system.”
BD and Scanwell Health also have plans to develop an app function meant to assist in automated test result reporting to public health agencies.
“Partnering with an industry leader like BD creates a unique opportunity to help millions of people test for the SARS-CoV-2 virus from the safety and comfort of their homes. Scanwell’s innovative computer vision technology closely mirrors that of point-of-care and laboratory diagnostic systems,” added Stephen Chen, founder and CEO of Scanwell Health. “We’re excited to leverage our experience in building FDA-cleared apps to bring this solution to market.”
Earlier in February, BD reported that the FDA had granted Emergency Use Authorization (EUA) for the company’s new molecular diagnostic test for both SARS-CoV-2 and Influenza A+B. The new test can return results in two to three hours, and it has also been CE marked to the IVD Directive.
“The guidelines from the US Centers for Disease Control and Prevention (CDC) recommend testing for both Flu and SARS-CoV-2 for all patients who are hospitalized and for patients who will not be hospitalized but for whom a positive result will change clinical management,” explained Dr. Charles K. Cooper, vice president of Medical and Scientific Affairs for Integrated Diagnostic Solutions at BD. “Since COVID-19 and Flu often present with similar symptoms, such as fever and dry cough, having a single specimen for accurate diagnosis speeds time to results and helps clinicians determine the right care more quickly to help prevent community transmission.”
The BD SARS-CoV-2/Flu assay is run on the BD MAX system, and distinguishes between SARS-CoV-2 and Influenza A+B — providing a positive or negative result for each virus with a single specimen. The EUA includes updated information in the test’s instructions for use that addresses SARS-COV-2 virus variants, including the UK and South African variants. A computer analysis has reportedly shown that 99.9% of the genetic sequences of these variants are an identical match to at least one of the two molecular targets for testing.
“Our diagnostic solutions for COVID-19 and Flu will help inform timely diagnosis and, ultimately, may contribute to faster and clinically appropriate patient management and treatment. In addition, the new information provided on the test’s ability to detect the UK and South African variants provides helpful guidance to health care practitioners as we look to identify and contain these new strains,” Hickey noted in a press release.
The BD SARS-CoV-2/Flu for BD MAX System kits are now available for ordering in the US and Europe.