QUEBEC CITY, Aug. 26 /PRNewswire-FirstCall/ – DiagnoCure Oncology Laboratories, based in West Chester, PA, a wholly-owned subsidiary of DiagnoCure Inc., announced today that it has received the U.S. CLIA certification required for the Company to launch its new laboratory developed Previstage(TM) GCC Colorectal Cancer Staging Test. The sales team can now actively promote the test, and the Company's U.S. clinical laboratory can perform it and report patient results worldwide.
Receiving this regulatory certification is a major accomplishment in DiagnoCure's growth strategy, which will strengthen our leadership position in high-value molecular cancer diagnostics. We can now provide clinicians and patients with a test using a technology that is 100,000 fold more sensitive than the current method of staging. We can help answer the fundamental question that every colorectal cancer patient asks after their surgery: Am I cured or has my cancer spread?", stated John Schafer, President and CEO of DiagnoCure.
DiagnoCure Oncology Laboratories will promote and offer the test directly to clinicians across the United States. Following the summer pre-launch marketing campaign, several physicians have already expressed interest in the test.
About Previstage(TM) GCC
Every year in North America, 174,000 people are diagnosed with colorectal cancer, and 142,000 colorectal cancer surgeries are performed. Staging a patient with colorectal cancer is crucial because it determines the patient's course of treatment after the surgery. Current standard of care requires that pathologists microscopically examine a thin slice of tissue from the lymph nodes harvested during the patient's surgery to see if cancer has spread. Currently, up to 25 – 30 percent of patients with no pathologically-positive lymph nodes (stage I and II cancers) later develop recurrent disease, presumably through occult metastases that have escaped detection. Most of these patients do not receive additional therapies such as chemotherapy. Previstage(TM) GCC provides clinicians with significantly more accurate information for staging a patient with colorectal cancer that will increase their confidence in making critical treatment decisions.
Strong data supports the potential for the GCC test to improve the current staging of colorectal patients. The National Cancer Institute sponsored a five-year prospective clinical trial of GCC testing in colorectal cancer patients. This study has been recently completed and the Company's collaborators at Thomas Jefferson University are presenting the results at major medical conferences throughout the year.