Almac Receives New York State Laboratory Permit for Trial Enrichment and Companion Diagnostics Development
CRAIGAVON, UK –Almac’s diagnostics business unit today announced that it 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.”
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
Almac’s diagnostics business unit focuses on the discovery, development and delivery of novel prognostic and predictive tests. Partnering with the biopharmaceutical industry, Almac support the discovery, development and delivery of companion diagnostics in addition to developing their own pipeline of oncology based tests in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.
Visit www.almacgroup.com, e-mail media@almacgroup.com
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