HepQuant Awarded COLA Accreditation for meeting US Clinical Laboratory Improvement Act (CLIA) and other Regulatory Requirements
By: Colorado BioScience Association Date: 08/30/2022
HepQuant, LLC, a Denver, Colorado-based company with a unique, patented and patent-pending technology for evaluating the liver in patients with chronic liver disease, today announced that the HepQuant laboratory has achieved COLA accreditation for laboratory quality assurance. COLA is a third-party accreditation organization that ensures labs comply with federal regulations, including those set by Clinical Laboratory Improvement Amendments (CLIA), the governing body that sets regulations for all clinical laboratories in the United States.
Through a mentoring approach using education to improve quality and patient safety, accreditation is given to laboratories that apply the highest standards of quality in day-to-day operations, demonstrate continued accuracy in the performance of proficiency testing, and pass a rigorous on-site laboratory survey. This COLA accreditation process reflects HepQuant’s dedication and long-term commitment to meeting standards that demonstrate a higher level of performance and patient care, COLA officials said.
“This marks an important milestone in our commercialization process,” noted Dr. Gregory Everson, CEO & Chief Medical Officer at HepQuant. “This certification means that our lab is ready to begin processing patient samples once FDA approval is obtained.”
“This is an accomplishment for the entire laboratory team at HepQuant,” said Sean Bundy, Chief Operating Officer at HepQuant. “An incredible effort went into ensuring that quality is embedded into our lab processes.”
COLA is a nonprofit, physician-directed organization promoting quality and excellence in medicine and patient care through programs of voluntary education, achievement and accreditation. In 1993, COLA was granted status by CMS to provide laboratory accreditation. Laboratories of all types and sizes are evaluated and mentored to produce accurate test results and meet CLIA (Clinical Laboratory Improvement Amendments) regulations. COLA is sponsored by the American Academy of Family Physicians, the American Medical Association, the American Society of Internal Medicine, and the American College of Physicians. For more information on COLA, please visit their website.
Headquartered in Denver, Colorado, HepQuant, LLC, is a privately held diagnostics company. HepQuant’s products are investigational combination drug and in-vitro diagnostic devices and have not yet been evaluated or reviewed by the US Food and Drug Administration (FDA) for commercial sale. They are currently available for investigational use via the FDA guidelines for investigational device exemptions (IDEs). For additional information, visit www.hepquant.com.
For further inquiries: Sean Bundy, MBA | Chief Operations Officer
Ph: (720) 651 – 4493 | Sean.Bundy@hepquant.com