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Exonhit Reports Key Progress in the Introduction of AclarusDx in the French IVD Market

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Exonhit announced today the signature of an agreement with Almac Diagnostics Limited which will serve as the reference laboratory for the analysis of samples tested with AclarusDx, its blood-based test intended to help in the diagnosis of Alzheimer’s disease (AD) and which is currently being introduced in the French IVD market. This agreement follows the successful technology transfer that was performed between Exonhit and Almac during the last few months.

“This partnership between Almac Diagnostics and Exonhit is an excellent arrangement for both companies. It will enable Exonhit to focus on the sales and marketing of AclarusDx while Almac Diagnostics will concentrate on the delivery of the diagnostic in its ISO17025 certified laboratory,” stated Professor Paul Harkin, President and Managing Director of Almac’s Diagnostics business.

“We chose Almac Diagnostics as our reference lab to perform the analytic phase of AclarusDx due to its strong expertise in molecular biology and its practice of the Affymetrix platform,” said Loic Maurel, M.D., Chairman of the Management Board at Exonhit. “We also view the location of Almac Diagnostics in Northern Ireland as an asset for the upcoming roll-out of AclarusDx in Europe.”

“This partnership between Almac Diagnostics and Exonhit is an excellent arrangement for both companies. It will enable Exonhit to focus on the sales and marketing of AclarusDx while Almac Diagnostics will concentrate on the delivery of the diagnostic in its ISO17025 certified laboratory,” stated Professor Paul Harkin, President and Managing Director of Almac’s Diagnostics business.

Almac Diagnostics will be the sole laboratory to analyze AclarusDx samples, thus ensuring the reproducibility of results obtained with this specialized assay.

In practice, memory centers will send their patient samples to Almac Diagnostics, Exonhit remaining in control of logistics. Almac’s clinical laboratory will extract the biological material (RNA) and perform the whole process up to hybridization and reading of microarrays. Data will be analyzed with the software developed by Exonhit to generate a report with the results of the test. It will be sent back to clinicians to aid them in making the diagnosis of their patients.

Almac Diagnostics will analyze all samples coming from memory clinics, as well as those coming from the clinical study in a real life setting. This study will include approximately 600 patients coming from a large number of memory clinics in France. It aims at supporting the use of AclarusDx within diagnostic algorithms currently used by memory centers to diagnose AD.

Source: Exonhit