NEW YORK – Genecast said on Monday that it will launch a clinical trial to assess whether its qPCR-based liquid biopsy test can detect EGFR mutations in early-stage non-small cell lung cancer, or NSCLC, patients.
The Seoul, South Korea-based diagnostics firm developed its liquid biopsy assay using allele-discriminating priming system, or ADPS, technology, which it says allows for simpler and faster diagnostics than other liquid biopsy technologies due to its high detection sensitivity.
In a clinical trial conducted at the Samsung Medical Center, the firm will now evaluate how well the test reflects the results of tumor-based EGFR mutation testing for patients with stage 1B to 3A NSCLC.
Should the trial validate the ADPS liquid biopsy's ability to pick up somatic EGFR mutations in this early-stage NSCLC population, Genecast hopes it will become a useful tool to guide anti-EGFR treatment decisions. Specifically, detecting EGFR mutations at the onset for early-stage NSCLC could identify patients eligible for adjuvant or neoadjuvant EGFR inhibitors such as osimertinib (AstraZeneca's Tagrisso), which has recently received regulatory approval in multiple countries — including the US and China — for early-stage NSCLC following surgical resection.
AstraZeneca is also evaluating neoadjuvant osimertinib — that is, administering the therapy prior to surgical resection — in a Phase III clinical trial for EGFR-mutated early-stage NSCLC. Neoadjuvant treatment with an EGFR TKI necessitates EGFR mutation detection prior to surgery, which, for early-stage patients without distant metastases, is much more feasible via blood-based diagnostics than tissue biopsy.
"With the recent FDA approval of osimertinib as an adjuvant therapy for early-stage NSCLC, the early diagnosis of this cancer using liquid biopsies is receiving attention again," Byungchul Lee, Genecast's chief technical officer, said in a statement. "If liquid biopsies can diagnose not only metastatic lung cancer, but also operable early-stage lung cancer, then they are likely to improve the survival rates of NSCLC patients."