To help diagnostics start-ups from around the world more rapidly enter the U.S. market, 20/20 GeneSystems, a clinical laboratory testing company based in Rockville, MD, has launched its Clinical Lab Innovation Axcelerator (CLIAx).

This shared CLIA laboratory facility offers nearly 3,000 square feet of ready-to-use communal clinical laboratory space and testing equipment, including a full PCR/molecular assay suite, next generation sequencing, immunoassay, and clinical chemistry capabilities. In addition, 20/20’s marketing and sales teams will help promote the new tests introduced by CLIAx’s clients. 

“Establishing and maintaining a compliant CLIA lab can be costly and daunting for young companies, especially those seeking to enter the American market from overseas,” says Jonathan Cohen, 20/20 president and CEO. “From leasing facilities to hiring qualified laboratory professionals, purchasing equipment, and running daily operations, it can be a hefty burden. These hurdles can limit or delay our nation’s access to some of the most creative and out-of-the-box testing solutions from around the world demonstrated during the pandemic to be in great demand. Our unique CLIAx accelerator removes or lowers many of the barriers in the path of these innovators.” 

In early September, the company signed an agreement with Australian-based Minomic International, a diagnostics firm that is gearing up to introduce MiCheck Prostate, a blood test that uses proprietary algorithms and biomarkers to estimate the risk of aggressive prostate cancer. 

“Our company is so excited to be working with the CLIAx team,” says Brad Walsh, PhD, CEO of Minomic International. “Their clinical lab accelerator is a unique concept that allows us to tap into the expertise in laboratory testing. It is just what Minomic requires – a ‘soft landing’ site to enter the U.S. market so we can focus on the key activity of test rollout instead of the necessary minutiae of setting up and running a lab service.” 

CLIAx was also officially designated by the Maryland Department of Commerce as a soft landing program for overseas companies seeking to enter the U.S. market.   

“Maryland is ‘open’ for international companies looking to expand, and the new Clinical Laboratory Innovation Axcelerator will provide the perfect soft landing for those seeking to explore the U.S. market,” says Maryland Commerce Secretary Kelly M. Schulz. “We applaud 20/20 GeneSystems for taking the lead with this initiative, and we hope to see similar spaces launch throughout the state.”

For more information, visit CLIAx.

Featured Image: 20/20 GeneSystems has started its CLIAx program to provide companies access to a CLIA laboratory space to develop their diagnostic tests. Photo: 20/20 GeneSystems