The company said the new facility will help support its on-going biomarker discovery and development strategy by allowing it to develop novel biomarkers for clinical use.
Commenting on the news, Paul Harkin, president and managing director of Almac‘s diagnostics business unit, said the lab had been opened to meet both Almac’s needs, and also those of its pharma partners.
“We have come to a point where the biomarkers we have discovered and assays that we have developed are being used to stratify patients, enrich clinical trials and impact patient treatment decisions,” he said.
“As such, CLIA is a key necessity for the processing of these samples.”
Developing pipeline
Almac said that in addition to standard molecular tests, it is also developing a pipeline of both internal clinical tests and companion diagnostic tests with its pharma partners. The company said the CLIA laboratory would play a large part in the testing process.
The firm’s genomics laboratories have been involved in biomarker discovery projects for the past eight years, with its diagnostics unit already operating under ISO17025 accreditation and working to Good Laboratory Practice (GLP) principles.
The company recently transferred its US staff to a new, custom-built $120m (€85m) facility just south of Philadelphia, US.
Minimum standards
Introduced in 1988, the Clinical Laboratory Improvement Amendments are US regulatory standards designed to improve the quality of testing in laboratories that examine human specimens.
During their two-year registration period, Almac can conduct ‘moderate or high complexity tests’ on the premises, after which full CLIA accreditation must be approved by Medicare and Medicaid - the US government administered health programs.
But since their introduction in 1988, CLIA regulations have been described as a thorn in the side of doctors, researchers and biotech companies, with critics claiming the approval process is lengthy, cumbersome and unnecessarily bureaucratic.