News & Views
Key step progresses CLIA Accreditation Process
Mar 17 2022
Announcing an update with regard to its clinical laboratory’s accreditation process that will enable Parsortix® tests to be used for patient management in the US, liquid biopsy company ANGLE has now been issued with a Certificate of Registration under the Clinical Laboratory Improvement Amendments (CLIA), by The Centers for Medicare and Medicaid Services (CMS). A Certificate of Compliance will follow successful completion of an inspection of the facilities and documentation on the validation of assays to be performed together with associated quality control procedures.
Accreditation of the company’s UK laboratory is also being progressed under parallel processes. The laboratories are intended as accelerators and demonstrators in support of the Company's strategic marketing plans. It is currently providing research use services to pharmaceutical and biotech customers running cancer drug trials.
ANGLE Chief Medical Officer, Dr Todd Druley, commented: “The issuance of a Certificate of Registration under CLIA is an important step towards accreditation of our United States clinical laboratory and the roll out of our commercial offerings in the United States with the intended launch of laboratory developed tests for patients. Accreditation will also provide recognition of the qualifications of our laboratory and critical assurances to support the growth in our pharma services business.”
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