TORONTO--(BUSINESS WIRE)--Xagenic, a molecular diagnostics company developing the lab-free Xagenic X1™ system designed to inform real-time treatment decisions, today announced that the Company will lead a panel discussing the intricacies of a CLIA waiver for near-patient, point of care diagnostic systems at the Molecular Med Tri-Con 2015, February 15-20 at the Moscone North Convention Center in San Francisco.
The molecular diagnostic (MDx) industry has been evolving toward point-of-care diagnostics for the past decade. However, because most MDx systems rely on PCR or other enzymatic methods, until recently no system has been simple enough to attain CLIA-waived status. Emerging MDx technologies enable simpler engineering and workflows, broadening access to POC diagnostics to larger markets like physicians’ offices.
“Obtaining CLIA-waived status is the foremost goal of next-generation diagnostic developers seeking to bring their platforms to the front line of diagnosis and treatment,” said Timothy I. Still, CEO of Xagenic. “CLIA-waived status broadens the customer base of a diagnostic system because it enables an untrained user to operate a diagnostic platform at the true point of care – the physician’s office.”
“Our panel discussion will detail the challenges and opportunities associated with obtaining a CLIA waiver with an audience of Tri-Con participants who share Xagenic’s vested interest in this process. We also look forward to sharing how Xagenic’s approach to near-patient diagnostics differs from our competitors’ with potential customers and collaborators attending this meeting,” Still said.
This session, led by Ihor Boszko, Xagenic Vice President of Business Development, Katherine Tynan, Ph.D., President of Tynan Consulting LLC and Fran White of President of MDC Associates, will explore commercial, regulatory, reimbursement and health economic aspects of CLIA-waived molecular diagnostic testing.
Program details are as follows:
Title: Luncheon Presentation II: CLIA Waived Molecular
Diagnostics: A Ripe Opportunity in the Age of Affordable Health Care
Date: Tues., Feb. 17
Time: 12:55 p.m. PT
Location: Moscone North Convention Center, Room 135
For more information about this session and about the 22nd International Molecular Medicine Tri-Conference, the industry's Preeminent Event on Molecular Medicine, please visit http://www.triconference.com/.
Xagenic is a privately-held molecular diagnostics company developing the Xagenic X1™ platform, a revolutionary diagnostic system designed from its inception for use in a clinician’s office. The Xagenic X1 platform will allow users to perform lab-quality molecular diagnostic tests in the physician office. With a time-to-result of 20 minutes, the system is poised to transform the way healthcare is delivered. The Company is backed by Domain Associates, CTI Life Sciences Fund, the Ontario Capital Growth Corporation, BDC Capital and Qiagen. Xagenic was the 2014 Frost & Sullivan Point-of-Care Diagnostics New Product Innovation Leadership Award winner. The Company is headquartered in Toronto with a San Francisco office. For more information, please visit www.xagenic.com.