GenWay Biotech Obtains Exclusive Rights To AMDL's DR-70 Cancer Test In US And Canada

Main Category: Medical Devices / Diagnostics
Also Included In: Cancer / Oncology;  Lung Cancer;  Regulatory Affairs / Drug Approvals
Article Date: 18 May 2009 - 0:00 PDT

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GenWay Biotech, Inc., a US-based diagnostic company which specializes in providing protein and antibody solutions, announced its partnership with AMDL, Inc., a US-based pharmaceutical company with major operations in China, regarding the distribution of AMDL's DR-70 (FDP) cancer test in both the United States and Canada. GenWay Biotech will be the exclusive distributor of the DR-70 test for general cancer screening by CLIA laboratories in the United States and for lung cancer screening in Canada. The commercialization efforts include raising awareness of the disease and demand creation for the test through multiple media channels and healthcare outreach. Both exclusive distribution agreements extend for five-years based on continuing success in both the Canadian and US markets.

The DR-70 cancer test has been approved by the US FDA for CRC monitoring and by Health Canada for Lung Cancer screening. However, a growing body of data reveals that the test is effective as a general cancer screen as well. The DR-70 ELISA assay quantifies Fibrin and Fibrinogen Degradation Products (FDP) in the blood, which are elevated in the presence of a malignant tumor and increase as the malignancy grows. International studies have linked the DR-70 cancer test to at least 14 different types of cancer, including lung, breast, stomach, liver, colon, rectal, ovarian, esophageal, cervical, trophoblastic, thyroid, malignant lymphoma, brain and pancreatic cancer making it one of the most versatile cancer biomarkers available.

The GenWay team is looking forward to the future impact of the DR-70 test in the field of cancer diagnostics. Robert Gans, CEO of GenWay Biotech Inc., says that, "The DR-70 cancer test can revolutionize the way people are able to easily screen their risk of cancer with a simple blood test. We are excited to play an instrumental role in advancing cancer diagnostics by making this test directly available to consumers. The marketing and distribution agreements for DR-70 will be financially significant programs for both GenWay and AMDL, while the impact and life-saving potential of this test personally drives our motivation for commercialization success."

The market potential for DR-70 is significant with an estimated 21,000 people in Canada diagnosed with Lung Cancer each year and close to 1.5 million Americans diagnosed with cancer each year (1,2). Since DR-70 is a non-invasive blood test that can be utilized for cancer screening, diagnosing, and monitoring, the test may play a significant role in cancer awareness and improving cancer treatment management.

The addition of the DR-70 test to GenWay's diagnostic portfolio further solidifies its presence as a robust and reliable provider of complete immunodiagnostic solutions. GenWay currently has the ability to produce immunodiagnostic solutions beginning with the biomarker or target gene sequence and then incorporate all the critical components needed into the final diagnostic kit.

1) Centre for Chronic Disease Prevention and Control. Public Health Agency of Canada (PHAC) http://www.phac-aspc.gc.ca
2) Cancer Statistics 2009. American Cancer Society, Inc. http://www.cancer.org

Source:
Dr. Jill Dombrauckas, PhD
GenWay Biotech