Panagene announced its plan to enter the global market with PANAMutyper R EGFR, a liquid biopsy kit, in a news conference Wednesday. The product is the first PNA-based liquid biopsy diagnostic kit released in Korea.
|Panagene CEO Kim Sung-kee|
In the past, doctors diagnosed cancer after a biopsy on a cancer-suspected tissue or cell. The procedure not only caused great pain to the patient but also had limitations in repeated treatment. Such limitations have given rise to interests in liquid biopsies that can detect the presence or absence of cancer and the type of cancer by examining the blood of a patient.
“The problem is that although there are many EGS-based and cancer-related blood test products on the market, most of them have limitations in their application to clinical diagnosis,” said Michael Haejin Park 박해진, chief technology officer for Panagene. “PANAMutyper targets EGFR, which is a clear target for certain mutations, increasing its efficacy and detection sensitivity.”
The product also only needs four milliliters of blood to run the test and can detect 0.1 percent amount of mutated genes with 99 percent accuracy.
Currently, Roche is the only company that has a liquid biopsy product for lung cancer approved by the U.S. Food and Drug Administration. With Panagene developing the first liquid biopsy product in Korea and preparing for an FDA approval, the two products are set to compete in the global market in the future, the company said.
In Korea, both liquid biopsy products were selected by the Ministry of Health and Welfare as a new medical technology on Oct. 16, and are awaiting insurance coverage assessment.
“The FDA has a high standard making it hard to obtain approval,” said Choi Jae-jin 최재진, general manager of Panagene. “Moreover, a diagnostic product that uses blood is ranked at the top of the FDA approval chain.”
To apply for FDA approval, Panagene 파나진 is updating its data by participating in phase 3 clinical trials of Tagrisso, AstraZeneca's non-small cell lung cancer drug, and Olita, Hanmi Pharmaceuticals 한미약품 non-small cell lung cancer drug, Choi added.
The cancer diagnosis market using liquid biopsies is expected to rapidly grow from $400 million in 2015 to $1.9 billion in 2020, according to a BCC research,
The company is also expanding its development area with diagnostic kits for cervical cancer, sexually transmitted infections, and other diseases as well as molecular diagnostic products based on their patented PNA technology.
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