Clinical Trials
4
0 active
Approvals
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Total approvals
Agencies
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Founded
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Completed
3
75.0%
Terminated
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25.0%
No approval data available
- Median overall turnaround time for tissue-based CGP in NSCLC improved from 36.6 days in 2018 to 27.0 days in 2024, driven largely by faster molecular laboratory processing. - The time from biopsy to CGP ordering remained stagnant at approximately 14 days and is now the largest contributor to overall delay. - Ordering turnaround time varied dramatically between clinical sites, with the slowest quintile taking 23.8 days versus 8.0 days in the fastest quintile. - Researchers urge multidisciplinary teams to audit internal workflows and consider reflex testing to ensure biomarker results guide first-line treatment decisions.
- SOPHiA GENETICS shareholders approved all AGM proposals, including the election of co-founder Dr. Jurgi Camblong as Executive Chairman with 99.79% of votes. - Ross Muken was elected to the Board and will assume the CEO role effective July 1, 2026, receiving 99.88% shareholder support. - The leadership transition follows a multi-year succession process and introduces a Lead Independent Director role with robust governance arrangements. - The company has scaled to nearly 1,000 healthcare institutions across more than 75 countries and surpassed 2 million genomic profiles analyzed on its SOPHiA DDM platform.
- The global oncology companion diagnostic market was valued at USD 5.09 billion in 2025 and is projected to reach USD 14.65 billion by 2035, growing at a CAGR of 11.09%. - North America held the largest revenue share at over 42.86% in 2025, with the U.S. market alone valued at USD 2.17 billion, fueled by FDA regulatory leadership in precision oncology. - Non-small cell lung cancer (NSCLC) dominated the market with approximately 31% share in 2025, while breast cancer represents the fastest-growing cancer type segment. - Next-generation sequencing (NGS) is the fastest-growing technology segment at a CAGR of 12.64%, reflecting increasing demand for comprehensive genomic profiling and multi-gene testing.
- The global precision medicine market is forecast to grow from $118.23 billion in 2025 to $456.81 billion by 2035, at a compound annual growth rate of 14.72%. - AI and machine learning diagnostic platforms represent the fastest-growing technology segment at a 19.3% CAGR, with the FDA approving 171 AI/ML-enabled medical devices in 2024 alone. - National genomics initiatives, including the U.S. All of Us program ($3.1 billion) and India's Genome India Initiative ($280 million), are creating population-scale datasets that underpin biomarker-driven therapy development. - Oncology remains the dominant application with approximately 43.5% market share in 2025, while rare and genetic disorders represent the fastest-growing application segment at 17.1% CAGR.
- The FDA has approved FoundationOne CDx as a companion diagnostic for tepotinib (TEPMETKO) to identify patients with metastatic non-small cell lung cancer harboring MET exon 14 skipping alterations. - This approval marks Foundation Medicine's first real-world data-powered companion diagnostic approval, leveraging curated clinical-genomic datasets to supplement clinical trial evidence. - Combined with the previously approved FoundationOne Liquid CDx, clinicians now have both tissue- and blood-based FDA-approved testing options for identifying patients eligible for tepotinib treatment. - MET exon 14 skipping alterations occur in approximately 3-4% of NSCLC cases and represent an actionable target with approved targeted therapy options.
- Roche has entered into a definitive merger agreement to acquire SAGA Diagnostics for up to $595 million, bringing the Pathlight tumor-informed molecular residual disease platform to Foundation Medicine. - Pathlight uses a proprietary combination of whole genome sequencing and digital PCR to identify structural variants, enabling ultra-sensitive detection of minimal residual disease in cancer patients. - The platform is currently covered by Medicare for cancer recurrence monitoring in early-stage breast cancer and has demonstrated strong clinical performance in breast and colorectal cancer. - The acquisition will expand Foundation Medicine's monitoring portfolio alongside existing tests like FoundationOne Monitor, with plans for international expansion and development of a decentralized MRD solution.
- Foundation Medicine launched its first Whole Genome Sequencing Germline test for research use, marking the company's expansion beyond oncology into cardiometabolic, immunologic, and neurologic disease areas. - The new WGS test provides comprehensive genome-wide coverage of both exonic and intronic regions through Foundation Medicine's FlexOMx Lab to support biopharmaceutical partners' translational research programs. - Foundation Medicine also announced a strategic partnership with SWOG Clinical Trials Partnerships, leveraging the company's 100 approved companion diagnostic indications across over 1,300 clinical sites nationwide. - The expansion represents Foundation Medicine's application of its precision medicine expertise from oncology to address critical diagnostic challenges across the broader healthcare ecosystem.
- Foundation Medicine has expanded its participation in the National Cancer Institute's ComboMATCH platform trials by including its FDA-approved blood-based biomarker test, FoundationOne Liquid CDx. - The initiative represents the largest biomarker-targeted cancer treatment combination testing program, aiming to identify promising treatments that can advance to larger clinical trials. - ComboMATCH tests whether genomically-guided therapy combinations may provide better patient outcomes than current standard of care for adults and children with cancer. - Foundation Medicine serves as a participating Designated Laboratory, allowing oncologists to use prior commercial testing results to determine patient eligibility for treatment trials.
- Pyxis Oncology has appointed Thomas Civik, a seasoned biotechnology executive with extensive oncology experience, as Interim CEO following the departure of Dr. Lara Sullivan. - The leadership transition aims to maintain continuity for the company's lead program MICVO, a first-in-concept antibody-drug conjugate targeting head and neck squamous cell carcinoma. - MICVO continues advancing through Phase 1 clinical studies as both monotherapy and in combination with pembrolizumab, having received FDA Fast Track Designation. - Civik brings proven experience from leading Five Prime Therapeutics through its $1.9 billion acquisition by Amgen and 17 years at Genentech overseeing major oncology therapies.
- UC San Diego researchers led the world's first clinical trial proving cancer treatments can be safely personalized using individual tumor DNA profiles, with results published in Journal of Clinical Oncology. - The I-PREDICT trial treated 210 advanced cancer patients with 157 different treatment regimens, including 103 novel drug combinations, with nearly 95% of patients having unique tumor DNA profiles. - Patients whose therapies were most closely matched to their tumor mutations experienced improved treatment response and survival rates without increased side effects. - The study establishes a foundation for precision oncology moving from "one-size-fits-all" to "one-size-fits-one" cancer treatment approaches.
