GRAIL Inc (Nasdaq: GRAL), a US-based healthcare company involved in early cancer detection, announced on Monday that the first patient has been tested for eligibility with the investigational GRAIL Non-Small Cell Lung Cancer (NSCLC) ctDNA Assay in the global TROPION-Lung12 Phase 3 study assessing adjuvant treatment regimens in patients with Stage I adenocarcinoma NSCLC.
UK-based AstraZeneca (LSE/STO/Nasdaq:AZN) is sponsoring the study in partnership with Japan-based Daiichi Sankyo (TSE: 4568).
Carried out under an FDA-approved Investigational Device Exemption application held by GRAIL, the study leverages GRAIL's targeted methylation platform to detect ctDNA. With GRAIL's blood-only approach, tissue analysis and bespoke panel development are not needed, enabling simple integration into pharmaceutical clinical trial workflows. Patients will be screened with the GRAIL assay prior to surgery to inform eligibility for post-surgery randomisation to an adjuvant treatment regimen.
Harpal Kumar, GRAIL president, International Business & Biopharma, said: "GRAIL's ctDNA detection approach, which does not require tumour tissue, has the potential to offer oncologists a rapid, accessible method to help refine patients' diagnostic and prognostic profiles for better guided cancer therapy. This is among the first times a ctDNA assay has been used in a clinical trial of early-stage lung cancer patients to identify those most likely to benefit from further treatment. As such, we hope this approach could provide substantial additional benefit for patients diagnosed with Stage 1 lung cancer."
Saluda Medical secures CE certification for EVA Sensing Technology in Europe
Antin to acquire clinical trial equipment provider Emsere
Hyphens Pharma licenses Cerapro skin cream to Louis Widmer for six European markets
Profusa signs French distributor to expand Lumee Oxygen rollout in Europe
Sensiva Health names new chief operating officer
BrioHealth Solutions enrols 100th participant in BrioVAD System trial
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
BioCryst wins FDA approval for oral HAE prophylaxis in young children
ALR Technologies announces GluCurve Pet CGM relaunch in Canada
Galderma secures EU MDR certification for Sculptra, expanding use to multiple body areas
Clinical Laserthermia Systems applies for CE marking of ClearPoint Prism neuro laser system