SEngine Precision Medicine Receives New York State CLEP Approval for PARIS® Test

• From a single sample taken from a patient’s tumor, SEngine scientists can discover which drugs or combinations of drugs are most effective in killing or disabling that individual’s cancer
• SEngine now certified to perform first patient-derived solid tumor organoid test for drug sensitivity in all 50 US states

SEATTLE, March 07, 2023 (GLOBE NEWSWIRE) — SEngine Precision Medicine, the precision oncology innovator matching patients to medicines based on their own tumor samples, has been certified through New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) to perform the PARIS^® Test on samples from the state, making the PARIS^® Test CLIA certified in all 50 states.

The first-in-class PARIS^® Test uses tissue from any solid tumor – including colon, breast, lung, ovarian, and pancreatic cancers – to generate actionable reports highlighting drug sensitivity for their individual disease.

SEngine’s PARIS^® Test consists of 3D organoids grown from patients’ own tumor cells in a lab, which can then be tested with a library of more than 240 small molecule drugs. The results decode the most effective treatment options that DNA sequencing alone cannot reveal. Our test also reveals which chemotherapies will most likely not work in a specific case, saving patients time, money, and unnecessary side effects.  More importantly, our test will help oncologists determine the best treatment strategy or clinical trial for each individual patient.

“With this rigorous certification process complete, patients in New York seeking treatment for cancer can more easily access our unique test, which measures and compares the response of their own cancer tissue to a range of possible therapies,” said Dr. Shalini Pereira, Clinical Laboratory Improvement Amendments (CLIA) Laboratory Director for SEngine. “We’re elated to partner with New York-based oncologists and cancer centers, as we have been throughout the rest of the country.”

“We are grateful to New York’s Department of Health for this approval. CLEP’s stringent standards are recognized as exceeding even federal CLIA benchmarks, marking this moment as confirmation of our dedication to following the science,” said SEngine CEO and co-founder Dr. Carla Grandori. “As the only high-throughput test of its kind, the PARIS^® Test represents a new hope for a growing number of patients with cancer and their care teams as they seek a personalized course of treatment. It’s the first step towards fulfilling our commitment to better, more precise cancer therapy.”

About PARIS^® Test
The PARIS Test is a next-generation diagnostic test that predicts drug responses integrating knowledge of cancer genomics with drug sensitivity testing of patient-derived live cells combined with robotics and proprietary algorithms. SEngine’s CLIA certified PARIS Test generates actionable drug sensitivity reports for patients and is applicable to all solid tumors including colon, breast, lung, ovarian and pancreatic cancer. Cancer derived cells grown in 3D outside the body maintain the functionality of the original tumor as well as its genomic characteristics. For cancers where a treatment path is not clear, such as many metastatic and recurrent cancers, the PARIS Test provides crucial information to treating physicians to match the right drug to the right patient.

About SEngine Precision Medicine
SEngine Precision Medicine Inc. is a precision oncology company revolutionizing cancer therapies by pre-testing drugs on patient-derived 3D cultures utilizing patient specific tumor cells. As a spin-out from world-renowned experts at the Fred Hutchinson Cancer Center, SEngine is leveraging over two decades of R&D in diagnostics and drug discovery. The company is commercializing the PARIS Test, a next-generation diagnostic test that predicts drug responses – integrating knowledge of cancer genomics with phenotypic testing of patient-derived live cells combined with robotics and proprietary algorithms. SEngine’s CLIA certified PARIS^® Test generates actionable drug sensitivity reports for patients with solid tumors. SEngine is also pursuing drug discovery via strategic collaborations with biopharmaceutical / pharma companies by deploying its precision oncology platform.

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