CERTIS ONCOLOGY ANNOUNCES CLIA CERTIFICATION FOR HIGH-COMPLEXITY TESTING
The Company has designed Laboratory Developed Tests for its innovative orthotopic PDX mouse modeling techniques to determine the best treatment options for cancer patients.
SAN DIEGO, JULY 16, 2018. Certis Oncology Solutions, Inc., a new precision medicine company focused on individualized patient care, today announced that it has received its CLIA Certificate of Registration for High-Complexity Testing. Certis will utilize the certificate to implement Laboratory Developed Tests for its Orthotopic PDX (Patient-Derived Xenograft) mouse models.
CLIA (Clinical Laboratory Improvement Amendments) refers to regulations enacted in 1988 to ensure quality standards for clinical laboratory testing. Zero deficiencies were cited in Certis’ application.
“Fewer than 10 percent of independent CLIA laboratories are certified to perform high-complexity tests, so this gives us a distinct competitive advantage in promoting our services” said Peter Ellman, Certis CEO. “We are now ramping up our operations, including expansion of our vivarium and tumor bank, which enables us to provide research services to pharmaceutical and biotech companies that foster the development of new cancer drugs.”
Pre-Clinical and Oncology/Patient Services
Certis’ innovative science fills the need for certainty. The Certis Orthotopic PDX precision mouse modeling techniques provide oncologists with more timely and accurate selection of treatment therapies. The science has been proven with publication of more than 40 peer-reviewed studies that validate the effectiveness of the techniques.
Certis implements the same techniques in pre-clinical services provided to pharmaceutical and biotech companies. Certis is operational and currently provides services including identifying patient-specific therapy, cryopreservation of tumors and Contract Research Organization (CRO) services.
“Certis makes a positive impact on people living with cancer,” said James Berglund, Chairman of Certis’ Board of Directors. “Concurrent testing of multiple drugs enabled by Orthotopic PDX models present oncologists with more treatment options – while reducing the time required to select each patient’s optimal treatment.”
“Certis Oncology is about the patients,” agreed Fritz C. Eilber, MD, UCLA Division of Surgical Oncology, and a member of Certis’ Board of Directors. “The goal is to improve and significantly impact patient’s lives. The ultimate individualized medicine is to have your tumor modeled.”
Certis derives revenue from three services:
1. Developing immortalized mouse models and cryopreserving individual patient tumors.
2. Testing potential drug therapies in these models by collaborating with oncologists to identify drug therapies that are effective and ineffective for individual patients.
3. Contract work for leading pharmaceutical and biotech companies.
About the Certis Orthotopic PDX Technique
Certis services are based on a technique known as Orthotopic PDX: Patient-Derived Xenografts. Orthotopic means “the correct place.” We take a very small specimen of the human patient’s tumor and surgically implant it into the corresponding anatomic location (pancreas, liver, lung, etc.) in immunodeficient mice.
Using our techniques, we have demonstrated the ability to rapidly grow individual patient tumors in mice at a high rate. The Orthotopic PDX models more accurately replicate human tumor growth, metastasis and response to therapy, making it more immediately clinically relevant than other models. The data created by Orthotopic PDX models has been used to obtain an experimental drug for a critically ill patient suffering from an aggressive cancer that was not in the standard treatment protocol. In this case, the data from the models resulted in FDA clearance of an off-market Investigational New Drug and the patient’s life was extended by more than two years with a high quality of life.
About Certis Oncology Solutions
Certis Oncology Solutions was formed in 2016 with the mission to provide individualized precision patient care. Our patient-directed therapy enables oncologists to tailor and optimize therapies for patients suffering from aggressive cancers. We also provide pre-clinical services for pharmaceutical and biotech companies. The differentiators for all of our services are the Certis Orthotopic PDX techniques. Certis is affiliated with leading cancer physicians at UCLA and Memorial Sloan Kettering.
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