AMDL has announced that the US Food and Drug Administration (FDA) has issued a letter of substantial equivalence to an existing predicate device and granted clearance to market the AMDL-ELISA DR-70(R) (FDP) as a safe and effective blood test for monitoring patients who have been previously diagnosed with colorectal cancer (CRC).
According to US-based medical research group Kalorama Research, the world market for in vitro diagnostic (IVD) tests for cancer is growing at nearly 11% annually and could reach nearly $8 billion by the end of 2012 (Kalorama Research Group: 2008). The FDA clearance to market was based upon data showing DR-70 (FDP) has the ability to monitor the progression of colorectal cancer post-surgery in patients who are biopsy confirmed with this disease.
"This clearance to market provides CRC patients with access to a potentially lifesaving test," said Gary Dreher, AMDL's chief executive officer. "Post-surgery testing with DR-70 is a valuable aid in monitoring disease progression in patients previously diagnosed with CRC. Today's announcement introduces a promising new choice for the hundreds of thousands of patients diagnosed with this potentially deadly, but highly treatable disease."
CRC is the third most common cancer worldwide and the second leading cause of cancer deaths (irrespective of gender) in the United States according to the National Cancer Institute (Cancer Facts and Figures 2008). It is estimated there will be approximately 150,000 new cases diagnosed in the US in 2008, roughly 51,000 deaths due to the disease, and almost half of all patients thought to be "cured" will develop a recurrence of CRC within 5 years -- usually due to undetected metastases. (Shike M, Winawer SJ, Greenwald PH, et al.: Bull World Health Organ).
Today's announcement marks the first clearance to market that the FDA has granted for any monitoring product for CRC since January 14, 1982 when Carcinoembryonic Antigen (CEA) was approved. Until now, the CEA test has been the only accepted method cleared in the U.S. DR-70 (FDP) offers a new test that can monitor CRC tumors post-surgery.
The DR-70 (FDP) test is cleared in Canada for the detection of lung cancer and was recently cleared to import in Korea and Taiwan as a general cancer screen. It also has the CE mark from the European Union for sale in Europe as a general cancer screen.