ST. LOUIS, MO — C2N Diagnostics has earned ISO 13485:2016 certification for its quality management system. In late 2020 C2N launched the PrecivityAD™ test, an innovative blood test intended for use with patients with cognitive impairment. The test aims to help health care providers better determine the presence or absence of amyloid plaques in the brain, a hallmark sign of Alzheimer’s disease.
ISO 13485:2016 certification is an internationally agreed standard that sets out the requirements for a quality management system specific to the medical devices industry. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations.
This news adds to C2N’s recent development that the Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to the company’s lab based on results of an on-site inspection. C2N’s state-of-the-art lab in the Cortex Innovation Community at 4340 Duncan Ave. in St. Louis also has earned Clinical Laboratory Improvement Amendments (CLIA) certification. CLIA regulates laboratory testing and requires clinical laboratories to be certified by the Centers for Medicare and Medicaid Services before they can accept human samples for diagnostic testing.
Joel Braunstein, MD, the CEO of C2N, says, “We’re very proud of our team for successfully completing the rigorous process to receive ISO 13485:2016. This designation is a testament to the virtues and commitment to quality that we embrace at C2N. We know our efforts make an important difference to health care providers and to their patients who are dealing with trying to understand whether symptoms of memory decline are due to Alzheimer’s disease or another condition. A correct diagnosis is the first step to an appropriate care management plan.”
The PrecivityAD™ blood test relies on precise and robust quantitation of the Amyloid Beta 42/40 ratio (Aβ 42/40) and determines the presence of apolipoprotein (ApoE)-specific peptides in blood samples using C2N’s proprietary mass spectrometry platform.
– This press release was provided by C2N Diagnostics