Company's shared lab to aid diagnostic test makers with US market hurdles

Marcus Robertson - Print  | 

Rockville, Md.-based lab testing company 20/20 GeneSystems has launched a shared lab to help diagnostic test makers cut the time and cost of launching their tests in the U.S., the company said Sept. 28.

“Establishing and maintaining a [Clinical Lab Improvement Amendments-compliant] 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 in a news release.

CLIA regulates labs that conduct tests on specimens taken from humans for the diagnosis, prevention or treatment of disease, or assessment of health. For a lab to meet CLIA certification, it must meet quality standards depending on the nature of testing performed there. Certification is required everywhere in the U.S. except Washington and, in some cases, New York.

The 3,000-square-foot 20/20 lab houses communal equipment, including a full PCR/molecular assay suite, next-generation sequencing, immunoassays, and clinical chemistry capabilities.

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