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news.BioLight Life Sciences Investments' cancer diagnostics subsidiary, Micromedic Technologies has entered into a collaboration agreement with Axella Research to advance the clinical and regulatory efforts required to commercialize the CellDetect non-invasive diagnostic test for the monitoring of bladder cancer recurrence in the US.
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Under terms of the Agreement, Axella will contribute over $1m in funding and the delivery of key clinical research organization (CRO) services, including the management and execution of a clinical trial, in order to obtain regulatory approval for the sales and marketing of CellDetect in the US.
In exchange for financing and CRO services, Axella will be entitled to royalties from future U.S.-based sales of CellDetect.
BioLight CEO Suzana Nahum Zilberberg said:"We are thrilled to announce this strategic partnership with Axella, which will yield meaningful progress towards regulatory approval of CellDetect in the United States, and accelerate the commercialization of this novel technology.
"With the highest recurrence rate of all cancers worldwide, there is a pressing need for improved diagnostic technologies to combat bladder cancer. CellDetect bladder cancer fills that void by delivering an accurate and reliable non-invasive test, offering significant commercial potential in the largest cancer diagnostics market in the world."
Micromedic is currently developing the CellDetect technology, which allows an accurate diagnosis of cancerous cells based on a unique combination of color differentiation and morphology, by utilizing a proprietary kit containing unique extract and dyes.
Earlier this year, BioLight announced that CellDetect bladder cancer monitoring had obtained CE Mark, enabling the product to be marketed and sold in Europe. This followed the successful completion of a blinded, multi-center clinical study of CellDetect in February 2015, which achieved the study’s primary endpoint for effectively detecting the recurrence of bladder cancer in subjects with a history of the disease.
The CellDetect bladder cancer test successfully identified cancerous cells in urine samples in patients with a history of the disease, with reported sensitivity of 84.4% and specificity of 82.7% for the study’s primary endpoint.
Micromedic plans to submit a Pre-IDE for the Product to the U.S. Food and Drug Administration in H1/2016.