BiologyWorks Granted ISO 13485:2016 Certification for COVID-19 Test

BiologyWorks, a medical test developer with a mission to deliver fast and accurate molecular testing, has earned (ISO) 13485:2016 certification for its quality management processes in medical device manufacturing. BiologyWorks is the developer of 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.
 
“We’re thrilled to receive the ISO 13485 certification as validation of our high standards for quality management in such a short time frame,” said Peter Marx, a co-founder of BiologyWorks. “Our focus remains on fast-tracking our molecular technology to deliver testing that is fast, private, affordable, and effective.”
 
The ISO 13485:2016 certification is granted when organizations that offer medical devices and related services have quality management systems that consistently meet customer and applicable regulatory requirements. ISO (International Organization for Standardization) is an independent, non-governmental international organization that supports innovation and the development of solutions to global issues through its standardized guidelines. This certification adds to BiologyWorks’ existing CE IVD European Council Directive 98/79/EC certification for manufacturers of in-vitro diagnostic medical devices in the European Union.
 
The BiologyWorks k(now) test is a small handheld and affordable device that delivers highly accurate results about infections or diseases with a recognizable 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.
 
BiologyWorks’ chemistry is patent-protected and based on years of research originating with the Alfred Mann Foundation and is supported by a grant from the Bill & Melinda Gates Foundation. The 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.
 
BiologyWorks is the creator of BiologyWorks k(now), usable for quickly identifying COVID-19 infections with an accuracy akin to PCR. The BiologyWorks k(now) test is an affordable small, handheld device and sample kit using a nasal swab. The patented molecular testing technologies are effective in a multitude of use cases ranging from infections and diseases to environmental contaminations.