Labcorp has introduced therascreen KRAS PCR Mutation Analysis, its companion diagnostic (CDx) to identify non-small cell lung cancer (NSCLC) in patients eligible for treatment with Amgen’s Lumakras (sotorasib).

Both Amgen’s Lumakras and Laborp’s therascreen KRAS PCR Mutation Analysis have received the US Food and Drug Administration (FDA) approval in May this year.

Lumakras was indicated for locally advanced or metastatic NSCLC patients with KRAS G12C-mutation, who have received at least one prior systemic therapy.

Labcorp is offering therascreen KRAS PCR Mutation Analysis assay as a companion diagnostic to determine the patients carrying a specific mutation in the KRAS gene.

Labcorp senior vice president and oncology head Prasanth Reddy said: “Every day, cancer patients across the country anxiously await test results that directly impact treatment decisions.

“Through our collaboration with QIAGEN and participation in their Day-One Lab Readiness Program, Labcorp is committed to ensuring critical biomarker testing for KRAS is immediately accessible to physicians to ensure every patient who may benefit from sotorasib is appropriately identified and treated.

“Labcorp is proud to be one of the first labs to make the therascreen KRAS test available, in addition to the many other diagnostic tests in our testing portfolio, including companion diagnostics that have been made available soon after FDA approval for breast, lung, colorectal, bladder and other cancers.”

The assay was originally developed by the German molecular diagnostics company Qiagen.

Labcorp has applied its scientific validation process to offer the assay through its CAP-accredited, CLIA-certified speciality labs.

The test uses a lung biopsy specimen to identify if an NSCLC patient has a specific mutation in the KRAS gene and determines their eligibility for the treatment with Amgen’s Lumakras.

Lumakras is claimed to be the first FDA-approved biomarker-driven, targeted therapy for the treatment of adults with KRAS G12C-positive NSCLC.

Qiagen oncology and precision diagnostics vice president Jonathan Arnold said: “We have a longstanding relationship with Labcorp and are delighted to collaborate with them again to bring this new companion diagnostic indication to NSCLC patients.

“The expanded indication on our Qiagen therascreen KRAS test will provide clinically relevant information to aid physicians in identifying patients eligible for a new class of treatment in NSCLC.”

For the last 25 years, Labcorp has been offering testing options for cancer treatment and is committed to further developing companion diagnostics and precision medicines.

Along with single-marker tests, the firm offers complete testing panels by leveraging next generation-sequencing (NGS) technology to profile a patient’s unique tumour.