Panagene said on Thursday that its OncoTector KRAS mutation test kit received approval from the Ministry of Food and Drug Safety as a grade 3 companion diagnostic (CDx) to support Lumakras (ingredient: sotorasib), a non-small cell lung cancer (NSCLC) treatment.

Lumakras is a targeted treatment for patients with locally progressive or metastatic NSCLC and is the first targeted anticancer drug targeting KRAS. However, the prescription of this drug requires confirmation of the presence or absence of the KRAS G12C mutation which can be conducted through CDx.

CDx is essential in prescribing targeted anticancer drugs, but only a few companies are competing in this diagnostic field as it is difficult to accurately detect small amounts of targeted gene mutations. 

Panagene, listed on the tech-heavy Kosdaq, is known to be one of the leaders in the Korean CDx market.

Panagene's OncoTector KRAS mutation test kit is a product that detects KRAS genes including six types of 12 codon mutations, and two 13 codon mutations, by applying its new molecular diagnostic platform AssiProbe technology.

AssiProbe can selectively amplify and detect only mutated target nucleic acids using the company's proprietary peptide nucleic acid, offering the advantage of a relatively smaller number of reaction tubes per sample with higher detection targets compared to other products. 

The company aims to patent this technology worldwide including in Korea.