AMDL (Tustin, California), a biopharmaceutical company with operations in China and the U.S., said the FDA has issued a letter of substantial equivalence to an existing predicate device and granted clearance to market the AMDL-ELISA DR-70 (FDP) as a safe and effective blood test for monitoring patients who have been previously diagnosed with colorectal cancer (CRC).
According to AMDL, this is the first monitoring product for CRC to win FDA clearance since Jan. 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, AMDL said.
The company filed for FDA clearance to market DR-70 last fall (Medical Device Daily, Oct. 18, 2007).
AMDL spokeswoman Kristine Szarkowitz told Medical Device Daily in an e-mail that DR-70 is a "completely new and unique" marker. "This is important to note because the approval process for new and/or unique' markers is typically an intense and lengthy process this was the case for DR-70. For me too products' where a company is submitting a like' product for approval to one that has already received approval, the FDA process is dramatically shortened. DR-70 was a unique marker, not a me too' marker."
Szarkowitz said the DR-70 ELISA test enables physicians to continuously test for the recurrence of CRC, providing a tool that can detect if the cancer returns at an earlier stage in some cases. In addition, she said, DR-70 has been shown to detect 13 other types of cancer, including lung cancer. However, it is only approved as a monitoring test in the U.S.
The DR-70 (FDP) test is cleared in Canada for the detection of lung cancer and was recently cleared in Korea and Taiwan as a general cancer screen. It also has the CE mark from the European Union for sale as a general cancer screen.
According to U.S.-based medical research group Kalorama Research, the world market for in vitro diagnostic tests for cancer is growing at nearly 11% annually and could reach nearly $8 billion by the end of 2012. The FDA clearance to market was based on 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, AMDL said.
"This clearance to market provides CRC patients with access to a potentially lifesaving test," said CEO Gary Dreher. "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 U.S., according to the National Cancer Institute. It is estimated there will be nearly 150,000 new cases diagnosed in the U.S. 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 five years — usually due to undetected metastases, the company noted.
AMDL has operations in Shenzhen, Jiangxi and Jilin, China. Along with its subsidiary Jade Pharmaceutical (Hong Kong), AMDL develops diagnostic, pharmaceutical, nutritional supplement and cosmetic products. The company employs about 320 people in the U.S. and China.