South Korea's CD BIO Seeks Clinical Trial, FDA Registration for Its VOCs Biosensing Kit That Detects Early Stage Lung and Other Cancers With Simple Breathing Test
The Korean biotech company, which has developed a Molecular Diagnostic Tester that detects lung cancer and various cancers at an early stage with a simple breathing test, plans for U.S. clinical trials and FDA registration.
LOS ANGELES, September 5, 2022 (Newswire.com) - Korean technicians announced on the 30th that they have developed a diagnostic device that diagnoses lung cancer from breathing tests. They have plans to submit the device for U.S. FDA approval and conduct further clinical trials.
To reduce the death rate that is increasing due to cancer, Korean company CD BIO's CEO, Baek Kyung-jin, has developed a diagnostic device VOCs Biosensing Kit that detects lung cancer and various cancers at an early stage with a simple breathing test.
Globalian, a company that opens up export opportunities and conducts export voucher programs with support from the Korean Academy of Clinical Health and the Korean government, has initiated FDA registration and the clinical trial process for CD BIO's VOCs Biosensing Kit through an export voucher program, collaborating with International Licensing Research Solutions, LLC (ILRS) and American Technology Clinical Solutions, Inc. (ATCS). ILRS and ATCS are collaborating, acting as U.S. agents for CD BIO, overseeing all aspects of international marketing.
The clinical trial on the effectiveness of detecting lung cancer and various cancers at an early stage with a simple breathing test was successful, and the thesis presentation was conducted. Now, the company is preparing for a clinical trial with a credible institution for follow-up tests, and at the same time planning to submit for FDA review in the United States in order to advance in the markets in the United States.
CD BIO's CEO, Baek Kyung-jin, said, "Through this clinical trial and the U.S. FDA [review] process, we will play the role of a tool to save people by combining the talents that God has given us with technology. It is the path that I have been praying for until now, and I believe that he will lead me in the future."
Next, he thanked all the technical staff and researchers who participated in the development and said that he will obtain the sober judgment and clear technology direction of the FDA.
Source: CD BIO