Agilent Technologies has signed an agreement with Quest Diagnostics to enable broad adoption for the former’s Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test to providers and patients in the US.
The US-based diagnostics firm said that ctDx FIRST is the first liquid biopsy test approved by the US Food and Drug Administration (FDA) as a companion diagnostic (CDx) for identifying patients with advanced non-small cell lung cancer (NSCLC) who could benefit from treatment with Mirati Therapeutics’ Krazati (adagrasib).
Under an FDA accelerated approval, Krazati is indicated to be used to treat adults with KRAS G12C-mutated locally advanced or metastatic NSCLC in those who have undergone at least one prior systemic therapy.
As per the agreement, Quest Diagnostics will make ctDx First available to healthcare professionals in the US who are looking for a minimally invasive liquid biopsy test alternative as a companion diagnostic for Krazati.
Through the Quest Diagnostics’ connectivity platform, healthcare providers can electronically order the test. Additionally, they can direct patients to one of the company’s 2,100 patient service facilities in the US to provide samples.
Healthcare providers will find it simpler to implement ctDx First as part of routine clinical treatment owing to the integration of Quest Diagnostics’ electronic health record platform and access to its nationwide patient centre network, according to Agilent Technologies.
Agilent Technologies companion diagnostics division vice president and general manager Paul Beresford said: “We are looking forward to the Quest Diagnostics alliance facilitating broad access to ctDx FIRST, our liquid biopsy solution.
“This expands the testing options available for NSCLC patients as patients don’t always have tissue available for molecular analysis.”
CtDx FIRST is said to be a single-site premarket approval (ssPMA) test carried out at the Resolution Bioscience CLIA laboratory in Kirkland, Washington.
Additionally, it is claimed as the first FDA-approved test for tumour profiling of the epidermal growth factor receptor (EGFR) gene in advanced NSCLC patients.
