ST. LOUIS, February 22, 2022–(BUSINESS WIRE)–C2N Diagnostics has obtained ISO 13485:2016 certification for its quality management system. End of 2020 C2N launched the PrecivityAD™ test, an innovative blood test for patients with cognitive impairment. The test aims to help healthcare 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 recognized standard that defines the requirements of a quality management system specific to the medical device industry. ISO 13485:2016 is designed to meet the latest quality management system practices, including technological developments and regulatory requirements and expectations.

This news adds to C2N’s recent development that the College of American Pathologists (CAP) Accreditation Committee granted accreditation to the company’s laboratory based on the results of an on-site inspection. VS2N’s state-of-the-art lab in the Cortex Innovation Community at 4340 Duncan Ave. in St. Louis also achieved CLIA (Clinical Laboratory Improvement Amendments) 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 specimens for diagnostic testing.

Joel Braunstein, MD, CEO of C2N, says, “We are very proud of our team for successfully completing the rigorous process to achieve ISO 13485:2016 certification. This designation is testament to the virtues and commitment to quality we embrace at C2N. We know that our efforts are making an important difference for healthcare providers and their patients who are trying to understand whether symptoms of memory decline are due to Alzheimer’s disease or another condition. A correct diagnosis is the first step towards an appropriate care management plan.”

The PrecivityAD™ blood test relies on accurate and robust quantification of the amyloid beta 42/40 (Aβ 42/40) ratio and determines the presence of apolipoprotein (ApoE)-specific peptides in blood samples using C2The proprietary mass spectrometry platform of N.

About C.2N Diagnostics, LLC

VS2N Diagnostics is a specialty diagnostics company whose vision is to bring Clarity Through Innovation™. VS2N strives to provide exceptional laboratory services and products in the field of brain health. VS2N’s biomarker services and products are used for: clinical decision making to improve patient care, including diagnosis and treatment monitoring; maximize the quality and effectiveness of clinical trials that test new treatments for neurodegeneration; and provide innovative tools to help healthcare researchers better understand new disease mechanisms, identify new treatment targets, and conduct important epidemiological studies to improve global public health. For more information, visit www.C2N.com.

See the source version on businesswire.com: https://www.businesswire.com/news/home/20220222005441/en/

contacts

MEDIA CONTACT:
Adam Shapiro
[email protected]
202-427-3603