Almac Receives New York State Laboratory Permit for Trial Enrichment and Companion Diagnostics Development
![](/46/pdcnewsitem/02/89/34/1ypSCq210Fwyna6.png)
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.”
Related News
-
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs... -
News Chasing new frontiers at LEAP – The National Biotechnology Strategy Keynote
On the third day of LEAP (4–7 March 2024, Riyadh Exhibition and Convention Centre, Malham, Saudi Arabia) the CPHI Middle East team hosted the Future Pharma Forum, to set the scene for an exciting new event for the pharma community, coming to Riya... -
News Pfizer maps out plans for developing new oncology therapeutics by 2030
Pfizer dilvulges plans to investors around growing their cancer portfolio, and the drugs they will be focusing on developing after their aquisition of Seagen in 2023. -
News Generics threat to Merck’s Bridion as Hikma seeks pre-patent expiry approval
Merck has disclosed they received notice from Hikma Pharmaceuticals for seeking a pre-patent expiry US FDA approval for Hikma’s generic version of Merck’s Bridion. -
News Bernie Sanders vs Big Pharma - the latest on drug price negotiations
In a hearing in front of the US Senate, three of the biggest pharmaceutical companies in America are challenged over exorbitant prescription drug prices, with Sanders claiming their actions are limiting the population's access to affordable healthc...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance