SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Cellworks Group, Inc., a leader in Personalized Therapy Decision Support and Precision Drug Development, today announced that its computational laboratory in Franklin, Tennessee, has obtained certification of compliance from the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA). This certification authorizes the lab to perform personalized therapy biosimulation for cancer patients within the U.S.
Cellworks' CLIA-certified biosimulation platform meets the rigorous standards required for clinical use, providing oncologists with a powerful tool to guide personalized treatment decisions and improve patient care. The platform leverages a mechanistic Computational Biosimulation Model (CBM) that uses genomic aberrations from a patient's cancer tumor to predict response to specific therapies. By combining mechanistic biology modeling, machine learning, and statistical analysis, the platform delivers patient-specific therapy response predictions to support treatment decisions.
"We are proud that our computational biosimulation lab has earned CLIA certification," said Yatin Mundkur, CEO of Cellworks. "This milestone underscores our commitment to uphold the highest standards of laboratory practice. CLIA certification validates the clinical reliability of our biosimulation platform and also enables us to participate in federal healthcare programs such as Medicare and Medicaid, broadening access to our innovative solutions. It marks a pivotal step in our mission to advance Personalized Therapy Decision Support and improve outcomes for cancer patients."
"CLIA certification exemplifies the stringent quality standards upheld by our laboratory, ensuring accuracy, reliability and precision,” said Dr. Michael J. Donovan, PhD, MD, Laboratory Director at Cellworks. “This achievement highlights our dedication to providing oncologists and their patients with clinically validated tools they can trust. We look forward to collaborating with oncologists to deliver innovative personalized therapeutic response predictions that have the potential to positively impact patients’ lives.”
The Cellworks Platform
The Cellworks Platform performs computational biosimulation of protein-protein interactions, enabling in silico modeling of tumor behavior using comprehensive genomic data. This allows for the evaluation of how personalized treatment strategies interact with the patient’s unique tumor network. Multi-omic data from an individual patient or cohort is used as input to the in silico Cellworks Computational Biology Model (CBM) to generate a personalized or cohort-specific disease model. The CBM is a highly curated mechanistic network of 6,000+ human genes, 30,000 molecular species and 600,000 molecular interactions. This model along with associated drug models are used to biosimulate the impact of specific compounds or combinations of drugs on the patient or cohort and produce therapy response predictions, which are statistically modeled to produce a qualitative Therapy Response Index (TRI) score, scaled from 0 (unfavorable outcome) to 100 (favorable outcome) for a specific therapy. The Cellworks CBM has been tested and applied against various clinical datasets with results provided in over 125 presentations and publications with global collaborators.
About Cellworks Group
Cellworks Group, Inc. is a leader in Personalized Therapy Decision Support and Precision Drug Development. The Cellworks Platform predicts therapy response for individual patients and patient cohorts using a breakthrough Computational Biology Model (CBM) and biosimulation technology. Backed by Artiman Ventures, Bering Capital, Sequoia Capital, UnitedHealth Group and Agilent Ventures, Cellworks has the world’s strongest trans-disciplinary team of molecular biologists, cellular pathway modelers and software engineers working toward a common goal – attacking serious diseases to improve the lives of patients. The company is based in South San Francisco, California with a CLIA-certified computational laboratory in Franklin, Tennessee and a research and development facility in Bangalore, India. For more information, visit cellworks.life.
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