NEW YORK (GenomeWeb News) – Exonhit today said that Almac Diagnostics will serve as the sole reference laboratory for testing performed with Exonhit's AclarusDx for Alzheimer's disease.
The deal calls for Almac to analyze all samples coming from memory clinics. Its clinical laboratory will extract RNA from test samples and perform the whole process up to hybridization and reading of microarrays, Exonhit said. Data will be analyzed with software developed by Exonhit, and reports will be generated and then sent to clinicians to help them make diagnoses.
Almac will also analyze samples from a clinical study being conducted on about 600 patients from memory clinics in France. The goal of the study is to support use of AclarusDx for the diagnosis of AD.
The blood-based test detects biomarkers specific to AD in peripheral blood. It has been available since 2009 for clinical use and is CE-marked. Exonhit said on its website that it is evaluating different options for a US launch, from an introduction as a laboratory-developed test to regulatory clearance from the US Food and Drug Administration.
Financial and other terms of the deal were not disclosed.
In a statement, Loic Maurel, chairman of the management board at Paris-based Exonhit, said that the company chose Almac as its reference lab because of its expertise in molecular biology and its use of the Affymetrix platform. "We also view the location of Almac Diagnostics in Northern Ireland as an asset for the upcoming roll-out of AclarusDx in Europe," he said.
Earlier this year, Almac received CLIA registration for a new lab to support the company's biomarker discovery and development strategy.
Today's agreement follows a successful technology transfer between the two companies during the past few months, Exonhit said.