Medical test developer BiologyWorks said on Tuesday that it has achieved ISO 13485:2016 certification for the BiologyWorks k(now) test, a fast molecular test for qualitative detection of pathogens and molecular biomarkers for SARS-CoV-2 and other viruses and infections.

The company said the BiologyWorks k(now) test is a small handheld and affordable device that delivers highly accurate results about infections or diseases with a recognisable gene sequence, including COVID-19. The device is easy to use, ultra-portable, safeguards patient data and eliminates the need for a diagnostic laboratory, providing fast, real-time results in less than 30 minutes.

Based on research originating with the Alfred Mann Foundation and supported by the Bill & Melinda Gates Foundation grant, the patent-protected BiologyWorks k(now) test has received a CE Mark and is available for point-of-care sale in Europe and many parts of the world.

ISO 13485:2016 certification is granted when organisations that offer medical devices and related services have quality management systems that consistently meet customer and applicable regulatory requirements. This certification adds to the company's existing CE IVD European Council Directive 98/79/EC certification for manufacturers of in vitro diagnostic medical devices in the EU.