The alliance will enable providers and patients throughout the United States to access the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing test.
The agreement between Quest and Agilent will enable broad adoption for ctDx FIRST, a single-site premarket approved (ssPMA) test performed at the Resolution Bioscience CLIA laboratory in Kirkland, Washington.
ctDx FIRST is the first liquid biopsy test approved by the US Food and Drug Administration as a companion diagnostic to identify advanced non-small cell lung cancer (NSCLC) patients who may benefit from treatment with KRAZATI.
KRAZATI (adagrasib) received accelerated approval as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
ctDx FIRST is also FDA-approved for tumor profiling of the epidermal growth factor receptor gene in accordance with professional guidelines in oncology for patients with advanced non-small cell lung cancer (NSCLC).
As a professional service, the ctDx FIRST test report includes comprehensive genomic profiling on 109 genes across four types of alterations: single nucleotide variants, indels, copy number amplifications, and fusions.
Under the terms of the agreement, Quest will offer ctDx FIRST to healthcare providers in the United States seeking a minimally invasive liquid biopsy test option as a CDx for KRAZATI.
Healthcare providers can order the test electronically through the Quest connectivity platform, which connects to hundreds of electronic medical records.
Healthcare providers may direct patients to provide specimens at one of Quest's 2,100 patient service centers across the United States.
Integrating Quest's electronic health record platform and access to its national patient center network will make it easier for healthcare providers to incorporate ctDx FIRST as part of regular clinical care.
Agilent and Quest have previously collaborated on Ki-67 IHC MIB-1 pharmDx and PD-L1.
Circio unveils circVec proof-of-concept
GSK releases decade-long data on Shingrix efficacy
BiVictriX receives FDA Orphan Drug Designation for AML treatment candidate
GSK announces positive EAGLE-1 results for gepotidacin in gonorrhoea treatment
Boehringer Ingelheim reports strong growth in 2023 and accelerates late-stage pipeline
Amneal announces launch of PEMRYDI RTU, a ready-to-use oncology injectable
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
GSK's meningitis vaccine candidate accepted for FDA review
Medivir and Vetbiolix report positive results from VBX-1000 Proof-of-Concept clinical study
Norgine submits first marketing authorisation application submissions for approval of eflornithine
Innovent Biologics names new Oncology CMO
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
ProAxsis secures GBP1.8m investment
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients