Champions Oncology Receives Regulatory Approval from New York State Department of Health
Hackensack, NJ – September 10, 2013 – Champions Oncology (OTC : CSBR) a company engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, announced today that it has received a clinical laboratory permit from the New York State Department of Health to provide its innovative Champions TumorGraft test to patients in New York. This approval, coupled with the existing Clinical Laboratory Improvement Amendment (“CLIA”) certification and other state approvals, enables Champions to offer its services without restrictions in 48 states. Champions TumorGraft test is the first and only in vivo sensitivity test approved and provides oncologists and patients with information that can predict the potential effect of a chemotherapeutic regimen on the patient’s specific tumor.
Dr. Ronnie Morris, President of Champions Oncology commented, “This is an important milestone for Champions. The NY DOH’s review was by far the most rigorous and thorough review of our clinical data to date. This approval further demonstrates the accuracy and clinical utility our test offers in personalizing care for cancer patients. In addition, the elimination of regulatory and marketing hurdles in such an important market will further our efforts to grow our Personalized Oncology business.”
Champions TumorGraft is a personalized approach that is used to determine the appropriate treatment for cancer patients. A piece of the patient’s living tumor is removed during surgery or biopsy and is implanted in mice. By implanting the tumor together with its microenvironment, the Champions TumorGraft grows and continues to closely resemble the patient’s tumor. Champions then tests drugs or drug combinations on the TumorGrafted mice and measures the response to each drug regimen. Champions TumorGrafts can predict the likely success of multiple therapies including single-agent and combination chemotherapy regimens, targeted biological drugs and anti-angiogenics.
Every Champions TumorGraft is preserved as a living sample for future patient use. These banked TumorGrafts can be re-grown and tested in the event of cancer progression or recurrence.
Champions’ TumorGrafts have been successfully tested in most solid tumor types including colorectal, ovarian, lung, breast, sarcoma, pancreatic, stomach, esophageal and others.