Angle PLC Announces Update On Laboratory Accreditation
ANGLE's US clinical laboratory issued Certificate of Registration, a key step to achieving CLIA accreditation
ANGLE plc, a world-leading liquid biopsy company, provides an update on the accreditation of its clinical laboratory in the United States to allow Parsortix tests to be offered for patient management.
The Centers for Medicare and Medicaid Services (CMS) has issued a Certificate of Registration, under the Clinical Laboratory Improvement Amendments (CLIA), to the Company's United States clinical laboratory. This is a key step towards achieving CLIA accreditation of the laboratory. Following CMS audit, including an inspection of the facilities and documentation on the validation of assays to be performed together with associated quality control procedures, a Certificate of Compliance will be issued. This will complete the accreditation process that permits the laboratory to process samples for patient management from the majority of the United States, with a small number of States requiring additional procedures which will be progressed separately.
As previously communicated, ANGLE has established clinical laboratories in the United States and the UK that have the capability of offering validated clinical tests for patient management. Accreditation of the UK laboratory is also being progressed under parallel processes in the UK. The laboratories are intended as accelerators and demonstrators in support of the Company's established plan for product sales of Parsortix instruments and cassettes for widespread medical use and are already actively 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."
Source: ANGLE plc