Under the terms of the agreement, Institut Gustave Roussy granted ExonHit an exclusive worldwide patent license to develop and commercialize a breast cancer molecular diagnostic. In return, Institut Gustave Roussy will receive an upfront payment as well as development milestones and royalties on future sales.

Institut Gustave Roussy in collaboration with the CNRS unit FRE 2939 identified a novel breast cancer signature, with an accuracy of over 95%, based on ExonHit’s proprietary SpliceArray platform (1). This new signature allows for the discrimination between malignant tumors and benign lesions from cells sampled through fine-needle aspiration (FNA). This research was conducted by Dr. Fabrice André and his team at the IGR.

“Institut Gustave Roussy pioneered the routine use of FNA in replacement of the more invasive core biopsy. This diagnostic method is specifically used in breast pathology routine exams during “the consultations and diagnosis in a day” program”,” said Professor Gilles Vassal, Head of Clinical and Translational Research at Institut Gustave Roussy, Villejuif France. “The assay that ExonHit is planning to develop could be an excellent tool to improve accuracy of FNA result, making it possible for more medical centers to adopt a practice which is less invasive and less traumatic for the patient.”

“The license of such a promising signature for breast cancer diagnosis is in line with our strategy to reinforce our diagnostic portfolio with simple, accurate and patient-friendly tests,” stated Dr. Loïc Maurel, President of the Management Board of ExonHit Therapeutics. “As our first non blood-based diagnostic, this is a different and complementary approach to our ongoing cancer diagnostic programs with bioMérieux.”

This signature may be used for all cases where FNA sampling is performed and is especially useful for “gray zone” cases where FNA results are inconclusive and either a surgical biopsy or an exploratory surgery is required to get a definitive answer. It is estimated that a cytologist is unable to provide a definitive diagnosis in 10 to 20% of cases where FNA samples are taken (2).

As part of the license, ExonHit will further validate the signature identified by Institut Gustave Roussy. This includes conducting multicenter evaluations, i.e. confirming the validity of the signature in a larger population and that the assay may be performed at different sites. For these validation studies, ExonHit will be able to use samples from Institut Gustave Roussy’s biobank.

Assuming successful clinical validation, ExonHit will first launch the test as a Research Use Only product within 12 months. Then, following further validation, the test will be launched as a clinical diagnostic.