바이오스펙테이터

바이오스펙테이터 Sungmin Kim 기자

The Korean molecular diagnostics company, Genomictree Inc., said on December 11 that its in vitro diagnostic (IVD) kit, EarlyTect® Colon Cancer, has obtained quality certification and marketing approval in Europe.

In a regulatory filing, Genomictree said that it registered European certification (CE-IVD) for EarlyTect® Colon Cancer on December 8 (product notification No.: (DE/CA70/40838-142367). This means that the kit meets the essential requirements of all relevant European Medical Device Directives. The CE mark is a legal requirement for selling a medical device in EU markets.

EarlyTect® Colon Cancer comprises a novel deoxyribonucleic acid (DNA) methylation biomarker, SDC2 (Syndecan-2), and is able to detect colorectal cancer using stool.

“The sensitivity and specificity of EarlyTect® Colon Cancer have shown to be superior to those of a competitor’s product,” said Genomictree’s CEO An Sung-whan.

“Starting with a new colorectal cancer kit, we will work together with more global partners to actively target the European market.”

Genomictree filed its patent application for EarlyTect® Colon Cancer in Europe. Its study results were presented in a number of international societies, and shared in many peer-reviewed scientific publications.

Currently, Epigenomics AG of Germany has developed DNA methylation based biomarkers for a number of oncology related indications. Among the CE marked IVDs licensed out to Novartis, Septin9 has a sensitivity of 71 % at a specificity of 81 %, when measuring the methylation status of Septin9 in blood for the detection of colon cancer.

By contrast, the clinical utility test of EarlyTect® Colon Cancer, which was designed to measure the methylation status of SDC2 biomarker gene in the stool (1.0 g) from 50 colorectal cancer patients (stage I, 10; II, 16; III, 14; IV, 10) and 50 healthy subjects, showed the sensitivity of 90.0 % at a specificity of 90.9 %. Notably, the sensitivity was high in stages I and II with 84.6 % (22/26). In addition, EarlyTect® Colon Cancer can detect a small polyp of less than 1 cm in the blood by 33.3 %, although its measure is technically challenging.

The research was featured in the December 4 online edition of the international journal Clinical Epigenetics.

CEO An explained that "Scientific papers are the most effective marketing tool, and enable us to publicize our first-in-class technology in the global market".

Meanwhile, for earlier commercialization of EarlyTect® Colon Cancer in Korea, Genomictree is conducting a confirmatory clinical trial in Yonsei University, based on the clinical utility results. The aim of this clinical trial is to obtain approval of the Class III medical device from the Ministry of Food and Drug Safety (MFDS).

CEO An said that "Since the confirmatory clinical trial for EarlyTect® Colon Cancer will be completed in the first quarter of 2018, we expect MFDS approval in the middle of next year.”

To launch a series of EarlyTect pipeline products, Genomictree is conducting additional clinical trials to develop IVD kits for the early detection of lung cancer and bladder cancer, as part of efforts to seek the approval of a Class III medical device. These trials are scheduled to be completed next year.