Panagene Succeeds in Developing 'ctDNA Mutation Test' KitLaunching a Total of 4 Breakthrough Commercial Products for Cancer Diagnostics

• To detect as little as 0.01% of the mutated oncogenes in blood within 3 hours
• To identify 41 different types of mutants related to lung and colorectal cancer biomarkers

SEOUL, South Korea--(BUSINESS WIRE)--Panagene has been in focus on news of having developed a commercial ctDNA test kits that can detect mutated oncogene through blood test alone. This technology is based on PNA (Peptide Nucleic Acid) and it can detect various mutated oncogenes in real-time.

Panagene (President Sung Kee Kim), a Korea company specializing in molecular diagnostics, announced the successful development of the 'C-melting technology'. Unlike traditional diagnostic products for invasive biopsy samples, this innovative ultra-sensitive test method makes it easy to effectively detect mutation from ctDNA in blood - as little as 0.01% of mutant ctDNA among excess of wild-type in blood can be detected in less than 3 hours.

The company explained "'C-melting technology' enabled this innovative, non-invasive, and easy method to accurately identify mutated oncogenes, unlike the 'PNAClamp technology', which is mainly used for invasive tissue biopsy".

A total of four products were launched with this technology applied. These products are targeted to detect lung and colorectal cancer biomarkers such as EGFR, KRAS, and NRAS: PANAMutyper^TM R EGFR T790M, PANAMutyper^TM R EGFR L858R, PANAMutyper^TM R KRAS series, and PANAMutyper^TM R NRAS series. These products are research use only, and regulatory approval process is currently underway.

The company stated "Our KRAS and NRAS ctDNA kits can accurately classify 19 and 20 genotypes of mutation, respectively, and EGFR ctDNA kit can identify acquired drug-resistance mutation induced by targeted-therapy." and "It's not just about pioneering the new market of cancer diagnostics in blood tests. We anticipate this breakthrough to facilitate the development of new anticancer drugs that are aimed to target each mutation variant".

Panagene Inc. is a leading PNA (Peptide Nucleic Acid) oligomer manufacturer, has developed various products based on PNA. In addition, the company has successfully commercialized diagnostic products in the domestic and competitive global markets. Panagene also specializes in mass production of PNA with strong patent portfolios and supplies products to more than 200 organizations in over 30 countries.