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ExonHit has developed its own diagnostic pipeline based on its unique gene to biomarker discovery process. We can detect diseases from peripheral tissues such as blood as well as from diseased tissues.

» Pipeline

Pipeline

ExonHit has developed its own diagnostic pipeline based on its unique gene to biomarker discovery process:

> Internal Development

> Co-development with Partners

Internal Development

AclarusDx™ is a blood based test to help in the diagnosis of Alzheimer’s disease (AD). It detects biomarkers specific of AD in peripheral blood.

AclarusDx™ has been available since December 2009 for clinical research performed by pharmaceutical companies and academic hospitals. The test is designed to improve patient’s selection for clinical trials in AD. It allows to discriminate patients from healthy individuals hence refining relevance of results.

The European launch of AclarusDx™ with laboratory partners in the clinical in vitro diagnostic market is planned for Q1 2011. This test is intended to be used in association with standard methods of assessment and will be help memory clinic experts in the diagnosis of Alzheimer’s disease.

Patients are currently identified through clinical and paraclinical examinations of their cognitive and physical state, rather than on the basis of quantifiable evidence of pathology. These examinations are part of long procedures and lead to a late diagnosis of Alzheimer’s disease. Treatments are more effective at the beginning of the disease, it is therefore of essence to move towards an earlier diagnosis.

AclarusDx™ was validated according to US and European norms (analytical and clinical validation). ExonHit Therapeutics is anticipating a CE marking in Q4 2010 for the European launch in the IVD market. Regarding US marketing approval, discussions have been initiated with the FDA to define the exact regulatory pathway to meet IVD requirements.

EHT Dx14, a novel breast cancer diagnostic biomarker developed using ExonHit’s SpliceArray™ platform, was licensed from Institut Gustave Roussy in May 2009. This test is intended to facilitate the reading of samples obtained by fine-needle aspiration (FNA) after a suspicious mass is discovered during mammography. Current methods are core needle biopsy or exploratory surgery. Performing EHT Dx14 could reduce the use of these invasive procedures and would shorten time to result.The molecular signature has been confirmed in a pilot study and ExonHit is proceeding with a large cohort for full validation. ExonHit plans to launch the test as a “research use only” product for oncology centers in 2H 2010.

EHT Dx12 aims at identifying specific biomarkers for colon cancer, a disease that responds well to treatment in its early stages. EHT Dx12 has the potential to become an alternative to colonoscopy, a more invasive diagnostics test.

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Co-development with Partners

Since October 2005, we have been collaborating with bioMerieux to discover and develop new cancer diagnostics in a variety of highly prevalent cancers with sub-optimal diagnostic procedures. In particular, we are working on discovering blood-based diagnostics for prostate cancer (EHT DX13).

EHT Dx13 has the potential to become the first blood-based diagnostic test with significantly increased accuracy compared to the widely used PSA (prostate specific antigen) test.

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