News Featuring Boudicca DX
Data from the FORESEE clinical feasibility study with previous client Biocept (clinical data acquired by Plus Therapeutics) was presented at the SNO Annual Meeting on November 24, 2024.
Priya Kumthekar 1, Michael Youssef 2, Jonathan Yang 3, David Piccioni 4, Sue Beruti 5, Laura Gillis 5, Kelly Gordon 6, Barbara Blouw 7, Melissa Moore 7, Norman LaFrance 7, Marc Hedrick 7, Seema Nagpal 8
1 Northwestern, Chicago/IL, USA, 2 UT Southwestern.edu, Dallas/TX, USA, 3 New York University, New York/NY, USA, 4 University of San Diego Health, San Diego/ CA, USA, 5 Independent Consultant, Winchester/VA, USA, 6 Independent Consultant, Brentwood/TN, USA, 7 Plus Therapeutics, Austin/TX, USA, 8 Stanford Medicine, Stanford/CA, USA
Leptomeningeal metastases (LM) in solid tumors is difficult to diagnose and treat, and occurs when there are cancer cells in the cerebrospinal fluid (CSF)/pia and arachnoid. Current standard of care methods to diagnose or assess treatment response of LM (Clinical Evaluation, MRI and Cytology) have limited sensitivity and specificity. This creates challenges for physicians to manage LM or determine the best course of treatment. The FORESEE Study was a multi-center, prospective clinical trial evaluating a novel diagnostic platform, CNSide, that aimed to overcome these challenges. The FORESEE study enrolled patients with breast or non-Small Cell Lung Cancer (NSCLC) with suspicion of or confirmed LM. CNSide can detect and quantify tumor cells in the CSF from patients with breast cancer or NSCLC having a suspicious or confirmed LM as well as identify actionable mutations in the CSF via Fluorescent In Situ Hybridization (FISH) and next-generation sequencing. The primary end point was to determine the impact of CNSide on physician treatment decisions. Secondary endpoints included evaluating the clinical performance of CNSide vs. cytology in tumor cell detection (sensitivity, specificity, PPV and NPV). The study enrolled 40 patients (22 breast cancer and 19 NSCLC). Each patient underwent standard of care diagnostic evaluations at baseline and at three follow up timepoints through their treatment. CNSide aided clinical decision making in 93% (50/54) of the clinical decisions. At baseline, 39 patients were assessed, showing that CNSide confirmed a positive LM diagnosis in 15% (6/39), a negative LM diagnosis in 8% (3/39), progression in 15% (6/39), resolution in 15% (6/39) and no progression, or resolution in 36% (14/39) of the patients. CNSide informed the specific drug selected for treatment in 26% (10/39) patients at baseline and demonstrated clinical high utility.
Presentation here:
Adial Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update
WBENC Certification is the most widely recognized and respected national certification for women-owned businesses in the United States. To become certified, business owners undergo a rigorous vetting process, including review of business documentation and a site visit. Boudicca Dx is proud to have received this certification.
1. Summarize Technical & Regulatory requirements for each phaseout step
2. Review the parallel FDA IVD Reclassification Process
3. Discuss Biopharma Clinical Trial Testing & Companion Diagnostic Opportunities for Laboratories
Earn CME credit: 1 hour.
Dr. Gordon will present on the Final FDA LDT Rule at an Open Scientific Discussion sponsored by AAPS Gene and Cell Therapy Products (GCTPs) and Biomarkers and Precision Medicine (BPM) Communities: “The Impact of the Latest FDA Regulations on Laboratory Developed Tests (LDTs) for Patient Management.”
White Papers & Quick Reference Guides
Proposed Framework for Leveraging a Distributed Pan-cancer Profiling IVD as a Companion Diagnostic for Oncology Targeted Molecular Therapies
Published online. September 9, 2024. Boudicca DX, LLC All rights reserved.
Disclaimer: The opinions expressed in this white paper are solely those of Boudicca DX, LLC and do not reflect those of any entity mentioned.
