The CLIA CoA follows the previously awarded Certificate of Registration, which permitted Proteocyte’s laboratory to temporarily conduct Straticyte™ (high complexity) tests until the company’s laboratory could be inspected.
This inspection has now taken place and Proteocyte has been found to be compliant with CLIA regulations.
The objective of the CLIA program is to ensure quality laboratory testing. The Division of Laboratory Services in the Central Office of the Centers for Medicare & Medicaid Services (CMS) of the U.S. Department of Health and Human Services is the primary contact for laboratories seeking CLIA certification.
In addition, the American Association for Laboratory Accreditation (A2LA) – the accreditation body working with Proteocyte to obtain the CoA – is among the largest of its kind in the world and has been approved by the CMS.
The CoA is yet another key step in Proteocyte’s regulatory process for the Straticyte oral dysplasia predictive test.
Anthony Morlandt, Chief Medical Officer USA at Proteocyte: “Receiving the Certificate of Accreditation means Straticyte continues to meet all the requirements needed to hit its commercial objectives. Speaking personally, the fact that I’m now able to use this test in my clinical practice for my patients gives it even greater validation.”