Highlights the value of companion diagnostics in the drug industry and the effectiveness of ctDNA testing in blood samples instead of invasive tumor biopsies for patient screening in clinical trials,
The assay demonstrated ctDNA liquid biopsy can be an alternative or complement to tissue samples and decrease sample failure rate,
Laboratory Developed Test (LDT) results demonstrated the assay was effective for patient selection and qualitative research indicated the value of ctDNA samples versus FFPE tissues.
MONMOUTH JUNCTION, N.J., Sept. 7, 2023 - Dr. Abdel Halim, Acutis Biosciences' Chief Scientific Officer, one of a group who led the study FOENIX-CCA2 (funded by Taiho Oncology and Taiho Pharmaceutical), recently published results about Futibatinib (LYTGOBI®) in cholangiocarcinoma with FGFR2 gene rearrangements/fusions in the New England Journal of Medicine (NEJM).
The study, a multinational phase 2 trial, enrolled patients with FGFR2 fusion/rearrangement–positive unresectable or metastatic intrahepatic cholangiocarcinoma who progressed after one or more previous lines of systemic therapy.
Patients were selected based on FGFR2 gene rearrangement/fusion in tumor tissue or liquid biopsy. Dr. Halim was responsible for ensuring the clinical trial assay (CTA) analytical validity and clinical utility in patient selection and addressing laboratory day-to-day issues. The study demonstrated the clinical value of circulating tumor DNA (ctDNA) in molecular profiling to assess patient's eligibility for targeted therapeutics.
"It can be an alternative or, at least, complement to tissue samples when those are not available. Using ctDNA testing in blood samples avoids invasive procedures for patients and decreases the analytical sample failure rate caused by insufficient quantity or quality of tissue biopsy. With ctDNA blood samples you are guaranteed as low as 1% failure rate compared to tumor tissues" said Dr. Halim.
Dr. Halim's outstanding expertise in the biomarker and precision medicine field brought him to lead biomarkers, translational medicine and precision medicine in 150+ PI-PIII clinical trials for more than 50 drug therapeutic areas, including 12 end-to-end companion diagnostic (CDx) projects on NGS, IHC and PCR, and enabling biomarker-driven patient selection in 35+ early phase trials using lab-developed-tests (LDTs). He is one of only four lab professionals in the USA with triple-board certification in Molecular Diagnostics, Clinical Chemistry and Toxicology, and licensed as CLIA clinical lab director in NY, NJ, FL and TN in several specialties. He is also an accredited FDA third-party reviewer of 510(K) for the different classes of IVDs.
Acutis CEO Jibreel Sarij added, "Dr. Halim and his team are making significant impact to bring forward clinical research testing and genomic profiling to enable biopharma with deeper insights and transform precision medicine".
About Acutis Bioscience:
Acutis Biosciences is a biomarker discovery provider to biopharmaceutical companies with next-generation multi-omics biomarker analysis solutions powered by machine learning (ML) and AI. With technology platforms in genomics and histopathology for development and validation of state-of-the-art cancer molecular diagnostic assays, in oncology, immuno-oncology and infectious diseases, Acutis redefines conventions with a unique customer engagement model coupled to extraordinary science.
More info: www.acutisbiosciences.com
For more information:
Troy Tremaine
Chief Commercial Officer
Senior Vice President
ttremaine@acutis.com
SOURCE Acutis Diagnostics Inc.
