Inscrit le: 07 Sep 2010
|Posté le: Ven 10 Juin - 07:36 (2011) Sujet du message: Lab CLIA pour les USA
|le 9 / 6 / 2011 :
Dans le domaine du diagnostic, Loïc Maurel a annoncé que l'AclarusDX, son test sanguin de la maladie d'Alzheimer, serait lancé en Allemagne, "vraisemblablement en 2012", après la France.
Les Etats-Unis suivront. En septembre, ExonHit compte lancer avec le spécialiste américain de la maladie d'Alzheimer, Jeffrey Cummings, une étude pilote de 180 patients qui pourrait être achevée à la fin 2012.
Plusieurs options de lancement aux Etats-Unis de ce test sont à l'étude, soit à travers un laboratoire de services (laboratoire Clia, qui offre une certification équivalente à la norme ISO en Europe), soit grâce à un accord de distribution, soit via l'acquisition d'une société de diagnostic moléculaire.
March 30, 2011
Almac open CLIA lab for biomarker clinical trials
Almac’s Diagnostics business unit today announced the opening of its CLIA registered laboratory.
The opening of the Almac CLIA Laboratory supports the company’s ongoing Biomarker Discovery and Development Strategy by enabling the use of novel tests to stratify and enrich prospective clinical trials. This ability is of key importance as Almac begins to transition the novel biomarkers that they have developed into clinical use, with the resulting potential to inform the drug development process and target therapies to responsive patients.
In addition to standard molecular tests, Almac have a pipeline of both internal clinical tests and companion diagnostic tests with Pharma partners in development that will be delivered from the Almac CLIA Laboratory.
Professor Paul Harkin, President and Managing Director of Almac’s Diagnostics business said:
“We are very happy to announce the launch of our CLIA lab, which has been opened to meet both our needs and the needs for our 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. As such, CLIA is a key necessity for the processing of these samples.”
Almac’s genomics laboratories have been supporting biomarker discovery projects for 8 years and already operate under ISO17025 accreditation and work to the principles of GLP.
Almac’s Diagnostics business unit is focused on the discovery and development of biomarkers. It utilises its proprietary technology, extensive experience and expertise to offer solutions to biotech and Pharma partners. Almac focus on providing a range of services including exploratory biomarker discovery studies, verification studies for existing markers, assay development and biomarker validation.
The Almac Group offers a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.
The company employs almost 3,000 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Staff have now transferred to Almac’s new $120m North American Headquarters which is now fully operational.
For more information about the Almac Group, please visit www.almacgroup.com or e-mail email@example.com