SEOUL, South Korea--(BUSINESS WIRE)--GENECAST, cancer diagnostics company through liquid biopsy, today announced the launch of ADPSTM BRAF, EGFR, JAK2 mutation test kits with the highest detection sensitivity for Research Use Only (RUO).
Especially ADPSTM BRAF mutation test kit has 0.0001% detection sensitivity which is 100 times higher than any other products, as well as EGFR and JAK2 mutation kits have the high detection sensitivity of 0.01%.
Detection sensitivity is the most important indicator of determining the accuracy of liquid biopsy. According to Butler TM, Spellman PT, Gray J. Circulating-tumor DNA as an early detection and diagnostic tool. Curr Opin Genet Dev 2017; 42:14-21, high detection sensitivity of 0.01% or less is important for early diagnose cancer using liquid biopsy.
ADPSTM BRAF mutation test kit can diagnose 4 BRAF mutations that are mainly found in thyroid cancer and melanoma with 0.0001% of detection sensitivity -meaning 3/3,000,000 mutation genes can be detected. It is 100 times better than ddPCR which previously had the highest detection sensitivity. Since ADPS technology is based on qPCR, it can reduce the expense and shorten clinical test time.
GENECAST is speeding up certification and approval procedures so that the kits can be used in the clinical fields. ADPSTM EGFR Mutation test kit which diagnoses EGFR- the most common cancer mutation in NSCLC, is in a process of FDA PMA. This is the world’s second trial as liquid biopsy cancer diagnostic kit. GENECAST plans to get FDA PMA approval by the second half of 2021. Also will prepare for CE-IVD after getting ISO 13485:2016 certification by this September.
“ADPS Oncology kits will show the possibility of precision medicine in the 1st and 2nd stage cancer patients,” said Ph.D. ByungChul Lee, CTO of GENECAST. “Yet, not becoming complacent, we will actualize early cancer diagnosis through liquid biopsy by continuously developing diverse cancer kits and new technologies.”
GENECAST will launch KRAS, NRAS, PIK3CA, pTERT, IDH1, IDH2 mutation test kits(RUO) by the end of 2019, and complete certification of CE-IVD for 9 Oncology kits by the first half of 2020.
GENECAST is a genetic testing start-up with liquid biopsy, specialized in monitoring cancer with original Allele-Discriminating Priming System (ADPS) that boasts an unprecedented sensitivity of 0.0001%. GENECAST’s mission is to make cancer as commonly curable disease by straightly face cancer with the highest detection sensitivity. ADPSTM EGFR mutation test kit is in the process of approving FDA PMA Class3 and aims to get approval by 2021. Besides ctDNA diagnostic technology, researchers are continuously developing new diagnostic technologies to fulfill the mission.