C2N Begins New Year with CAP Accreditation Award, the Highest Standard in Laboratory Practices

ST. LOUIS--(BUSINESS WIRE)--C₂N Diagnostics continues to build on its mission to provide exceptional laboratory services and products in the field of brain health. Its latest success is the news that the Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to C₂N’s lab based on results of a recent on-site inspection.

The accreditation for C₂N’s state-of-the-art lab in the Cortex Innovation Community at 4340 Duncan Ave. in St. Louis is in addition to its 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.

CAP informed the facility's director, John H. Contois, Ph.D., DABCC, of this national recognition and congratulated the company for the excellence of the services being provided.

The U.S. federal government recognizes the CAP Laboratory Accreditation Program, begun in the early 1960s, as being equal to or more stringent than the government's own inspection program.

During the CAP accreditation process, designed to ensure the highest standard of care for all laboratory patients, inspectors examine the laboratory's records and quality control of procedures for the preceding two years. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety program and record, and overall management.

Joel Braunstein, M.D., the CEO of C₂N, says, “We thank the Accreditation Committee of the College of American Pathologists for its thorough review and for awarding C₂N this important distinction. We also congratulate our employees for their dedication in achieving this accreditation along with the other milestones we reached in 2021. Most of all, we’re proud of our efforts to help health care providers understand if their patients’ symptoms are due to Alzheimer’s disease and how the PrecivityAD™ blood test results can help inform them in prescribing specific Alzheimer’s treatments in order to aid in the management of the disease.”

Preparing for an Even More Impactful 2022

Four separate research reports presented at premier Alzheimer’s disease and aging conferences in late 2021 added to the increasing set of details about the accuracy of the PrecivityAD™ blood test from C₂N Diagnostics.

In addition, the AHEAD Study, a landmark prevention trial occurring at 75 research centers aimed at preventing memory loss in high-risk individuals, announced that it will use the PrecivityAD™ blood test to provide an initial screen for study eligibility. This is the first time the PrecivityAD™ blood test will be used this way.

Dr. Braunstein added, “We are looking forward to an impactful 2022 where our PrecivityAD™ blood test and additional innovations from C₂N will continue to advance our vision to provide the highest quality and best clinical value in brain health diagnostics.”

The PrecivityAD™ blood test identifies whether a patient is likely to have amyloid plaques in the brain. The test relies on precise and robust quantitation of the Amyloid Beta 42/40 ratio (Aβ 42/40) and determines the presence of detection of apolipoprotein (ApoE)-specific peptides in blood samples, using C₂N’s proprietary mass spectrometry platform.

The PrecivityAD™ test is intended for use in individuals experiencing memory and thinking issues. The test is only available through an order by a health care provider.

About C₂N Diagnostics, LLC

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