By Turna Ray
Almac Diagnostics announced this week that it will serve as the reference lab for Exonhit's AclarusDx test for Alzheimer's diagnosis.
Under the terms of the agreement, Paris-based Exonhit will focus on marketing AclarusDx while Almac will run the test in its accredited laboratory in Craigavon, UK, and deliver the results to clinicians.
AclarusDx is a microarray-based test developed to aid clinicians in assessing which patients have Alzheimer's disease. The test, which gauges the expression of approximately 130 genes implicated in the inflammatory and immune mechanisms associated with Alzheimer's, received CE-marking in Europe in March. Currently, the test is available as a clinical diagnostic in France.
A spokesperson from Almac told PGx Reporter that the company will run AclarusDx on the Affymetrix Dx2 platform. The test is based on Exonhit's proprietary biochip, a customized Affy GeneChip called the Genome Wide SpliceArray. The test "measures transcriptomic changes comparing Alzheimer's patients to non-demented subjects," the spokesperson noted.
"We … view the location of Almac Diagnostics in Northern Ireland as an asset for the upcoming roll-out of AclarusDx in Europe," Loïc Maurel, Exonhit's chairman, said in a statement. The company is focused on developing personalized therapeutic and diagnostic products for patients with cancer and Alzheimer’s disease.
With CE-marking, AclarusDx can be marketed for in vitro diagnostic use across Europe, but Exonhit to date has been "progressively introducing it in France, primarily through memory centers," according to the Almac spokesperson. Clinicians at memory clinics collect patient blood samples and send them to Almac for analysis.
Although AclarusDx is not available in the US, Exonhit has been eyeing that market as well. As reported by PGx Reporter sister publication BioArray News, Exonhit is in discussions with the US Food and Drug Administration about gaining clearance to launch the test in the US by the first quarter of next year.
According to the Almac spokesperson, Exonhit is planning a pilot study to assess AclarusDx in the US. "Right now the test is developed only to be an aid in the diagnosis" of Alzheimer's, the spokesperson said, noting that there may be opportunities for growing the test's indication as an aid in helping doctors personalize treatments for patients.
"To help in treatment management, we need to use the capability of the Genome-Wide SpliceArray chip to define drug-related signatures. This could be managed in partnership with pharmaceutical companies," the spokesperson said.
Almac's lab in Northern Ireland is ISO17025-accredited as well as CLIA-certified, a fact that should bolster Exonhit's US expansion hopes for AclarusDx.
Almac said that the deal with Exonhit is its second commercial molecular diagnostic partnership. After opening its CLIA lab earlier this year, the company began delivering Qiagen/Dxs' Therascreen KRAS Mutation Test, which is used to gauge best responders to the colorectal cancer drugs Vectibix and Erbitux.
Almac is also developing oncology diagnostics on its own. Several years ago, Almac and Lilly UK began developing a companion diagnostic to gauge which patients with non-squamous non-small cell lung cancer would benefit from treatment with Alimta and cisplatin combination therapy (PGx Reporter 09/16/2009).
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