US-based biotechnology company Transgenomic (TBIO) has introduced its new CLIA assays to detect the presence of the EGFR C797S mutation to address non-small cell lung cancer (NSCLC).

EGFR C797S resists the third-generation tyrosine kinase inhibitor (TKI) drugs which are administered to treat NSCLC.

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The C797S detection tests are ultra-high sensitivity assays based on TBIO’s Multiplexed ICE COLD-PCR (MX-ICP) enrichment technology and designed to provide results from tissue, blood or serum samples with accuracy.

"These unique ICP CLIA assays provide potentially lifesaving information by enabling the ongoing testing and optimal treatment of lung cancer patients."

ICE COLD-PCR promotes a selective amplification of mutant DNA which results in better mutation identification with sensitivity and a precise sequence alteration detection rate.

It allows the testing of a patient to detect drug resistant components before administration.

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The C797S detection test is available as a single assay and in three panels which are TBIO’s EGFR-TKI resistance panel that also tests for the EGFR T790M mutation, its MX-ICP EGFR NSCLC panel and its MX-ICP EGFR analysis panel.

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TBIO president and CEO Paul Kinnon said: “This is our tenth CLIA-certified ICP assay for the detection of actionable cancer mutations, with many more slated for commercial release in the coming months.

“Our ICP technology is an ideal solution for the repeat DNA testing needed to capitalise on new cancer treatments it has high-sensitivity and requires very small amounts of sample, thereby enabling the liquid biopsies needed for ongoing patient monitoring.

“These unique ICP CLIA assays provide potentially lifesaving information by enabling the ongoing testing and optimal treatment of lung cancer patients.”

The EGFR C797S assay is applicable on patients with NSCLC eligible to be treated with EGFR-TKI drugs.