Almac Receives New York State Laboratory Permit for Trial Enrichment and Companion Diagnostics Development

Almac’s diagnostics business unit has received a Clinical Laboratory Permit from the New York State Department of Health, allowing them to receive patient samples for clinical testing from New York.

Designed to ensure high quality, reliable and accurate clinical laboratory services, the New York State Clinical Laboratory Permit is known for its stringent requirements for laboratory test approval and is recognised as one of the most difficult to obtain.

In addition, Almac have also successfully retained their CAP and CLIA accreditation following an inspection by the College of American Pathologists (CAP). CAP has led as the gold standard in laboratory accreditation for more than 50 years and the stringent inspection program is designed to specifically ensure the highest standard of care for all laboratory patients.

Almac is focused on personalised medicine, providing biomarker services to the pharmaceutical and biotech industry. Services range from early phase trial enrichment to full companion diagnostic development with a focus on multiplex signatures. The recent accreditation will now allow Almac to receive patient samples from New York for clinical testing and trial management.

“The growing importance of biomarkers in personalised medicine means that our clinical testing laboratories need to meet the highest standards of quality and safety” said Richard Kennedy, Clinical Laboratory Director at Almac, “the successful receipt of the Clinical Laboratory Evaluation Program (CLEP) permit together with the recent renewal of our CAP accreditation demonstrates that we meet these standards and provides confidence to our clients.”