NEW YORK – SEngine Precision Medicine said on Tuesday that it received certification through the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP) for the firm's Paris test, which generates actionable drug sensitivity reports using tissue from any solid tumor.
The Paris test comprises 3D organoids grown from a patient's own tumor cells, which are tested against a library of over 240 small molecule drugs. SEngine Cofounder and CEO Carla Grandori said the New York state CLEP approval will open an important new market where previously the company had to request a special permit for each patient test. "SEngine has already worked with oncologists and research collaborators in the New York area — at Columbia University, Cornell University, NewYork-Presbyterian Hospital, Weill Cornell Medicine, Memorial Sloan Kettering Cancer Center, and New York Stem Cell Foundation, to name a few," said Grandori in an interview.
With the New York state approval, Paris is now available in all 50 states.
Seattle-based SEngine was spun out of the Fred Hutchinson Cancer Research Center in 2015 to develop the Paris platform. In 2022, it raised $19 million in a Series A financing round to fund clinical validation of the test as well as its drug discovery initiatives.
SEngine is studying the use of Paris to make treatment recommendations for patients with advanced refractory cancers in three studies that make up the ORGANOTREAT clinical trial. ORGANOTREAT-01 is a Phase I study for patients with advanced colorectal cancer only. ORGANOTREAT-02A and -02B are Phase II studies in advanced solid cancers. Patients in the trials are treated according to recommendations of the Chemogram Tumor Board, which is informed by the results of the Paris test.