Aptamer Science, received approval early diagnostic kit for lung cancer
입력 2017-10-11 10:44 수정 2017-10-11 10:44
바이오스펙테이터 Jongwon Jang 기자
An early diagnostic kit for lung cancer using the nucleic acid material, Aptamer, was first approved in Korea. On 27th, Aptamer Science revealed that their self-developed ‘AptoDetectTm-Lung’, which is an early diagnostic kit for lung cancer, received approval as a class III medical device from KFDA.
Aptamer Science is a company that develops innovative diagnostic kit products and new drugs using Aptamer technology, utilizing a nucleic acid material with high specificity and sensitivity to various target substances. Approved this time, ‘AptoDetectTm-Lung’ measures, by using Aptamer technology, 7 different protein types in the blood simultaneously, analyzes them using an algorithm, and then provides a person’s lung cancer risk. The company explained that this is the first product in the world developed to test multiple indices in the form of a in-vitro diagnostic kit using Aptamer technology.
Mr. Kim Ki-seok, the head of research center, said, “We have had to get re-examinations periodically and several times when a nodule has been found on low-dose chest CT until now. And, now, we can avoid this nuisance when we use AptoDetectTm-Lung together with low-dose chest CT exam.
Collaborated with Seoul Asan Medical center, a clinical trial for AptoDetectTm-Lung included subjects with positive chest nodule. Kit’s sensitivity and specificity were 75% and 92%, respectively, and the positive predictive value of lung cancer was improved by more than six times of the standard. The results were published in ‘Clinical Lung Cancer’, a global journal, in last September.
Mr. Han Dong-il, the CEO of Aptamer Science, said, “Recently, the demand of early diagnosis technology is getting bigger since the cancer treatment options are now various by the development of new technology from targeted cancer treatment to immunotherapeutic treatment, called ‘paradigm shift’. Developed with the current trend of modern medical care, AptoDetectTm-Lung enables the early diagnosis of lung cancer and this means a lot. We will try to develop a product that can make diagnosis early to help various cancer diseases like pancreatic cancer that does not have early diagnosis methods, which end up bringing the difficulty to treat.