Called Clinical Lab Innovation Axcellerator (CLIAx), the company said it believes the facility is the first shared CLIA laboratory facility geared to helping diagnostic test innovators worldwide substantially reduce the time and cost of launching their tests in the U.S.
“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,” 20/20 President and CEO, Jonathan Cohen said. “Our unique CLIA Axcellerator removes or lowers many of the barriers in the path of these innovators.”
CLIAx has nearly 3,000 square feet of ready-to-use communal clinical laboratory space and testing equipment, including a full PCR/molecular assay suite, NextGen Sequencing (NGS), immunoassay, and clinical chemistry capabilities. Importantly, 20/20’s marketing and sales teams will help promote the new tests introduced by CLIAx’s clients to the market segments in which 20/20 is currently active.
Earlier this month 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.
CLIAx was 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 Axcellerator will provide the perfect soft landing for those seeking to explore the U.S. market," said Maryland Commerce Secretary Kelly M. Schulz.
20/20 GeneSystems, based in Rockville, MD, offers OneTest, a blood test to aid in the early detection of multiple cancers, as well as several COVID-19 testing solutions including viral tests based on PCR and point-of-care, rapid antibody and antigen tests.
