At Color we’re proud that our genetics laboratory meets the most stringent clinical standards. In 2015 we received a certificate of accreditation from the College of American Pathologists (CAP) and a Clinical Laboratory Improvements Amendments (CLIA) certification. Together these certifications approved our company to offer the Color Test in 49 states in the US.
As for that last state: today, we’re pleased to announce that we’re open for business in New York. The Empire State has one of the most comprehensive laboratory evaluation programs in the US. Along with CAP and CLIA, clinical labs that want to offer genetic testing in New York State must also obtain a permit from New York’s Clinical Laboratory Evaluation Program (CLEP). This permit requires substantive review of the applicant’s validations, protocols, and ordering processes, along with published journal articles demonstrating the clinical validity of genetic testing services.
In other words, it’s rigorous. According to the American Clinical Laboratory Association, there are 300,000 laboratories in the US, and only 985 of them (0.3%) have achieved this level of quality and become licensed by the New York State Department of Health. We’re thrilled that Color is one of them.
With today’s announcement, the Color Test is now officially available in all 50 US states and more than 150 countries, and we’re one step closer to our ultimate goal of enabling universal access to physician-ordered genetic testing for hereditary cancer risk. We look forward to serving New Yorkers and their families.