TEST:

FoundationOne®Tracker

P=N/A, N=103, Recruiting, Jules Bordet Institute | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Jan 2026 --> Apr 2026

Analytical sensitivity is shown to be >97.3% at ≥5 mean tumor molecules per mL of plasma (MTM/mL) when tested with the most conservative configuration using only two monitorable alterations. The assay also demonstrates high analytical accuracy when compared to liquid biopsy-based CGP as well as high qualitative (measured 100% PPA) and quantitative precision (<11.2% coefficient of variation).

Relton, BMJ. 2010.

"Foundation Medicine, Inc...announced that research from its robust oncology diagnostics portfolio will be presented at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, California April 5-10, 2024....In a retrospective study of 58 patients from the Genentech, a member of the Roche Group, MyPathway study (NCT02091141)...Results suggest ​serial early ctDNA monitoring ​is a valuable complementary tool for real-time treatment response monitoring to targeted therapy....Leveraging plasma collected serially from patients in Genentech’s Prospective Clinico-Genomic (PCG) study (NCT04180176), the FoundationOne Monitor assay was used to investigate ctDNA tumor fraction for monitoring treatment response."

Tumor-informed ctDNA monitoring provides insight into early treatment response and survival outcomes in patients with diverse HER2 amplified or mutated tumors receiving HER2 targeted therapy. On-treatment ctDNA dynamics refine and can potentially detect response/progression ahead of standard of care response assessments, suggesting early ctDNA monitoring as a valuable complementary tool for real-time treatment response monitoring.

Selection criteria include pts: a) with HR+/HER2- EBC at high risk of relapse, b) on adjuvant treatment with endocrine therapy (ET) for at least 2 years with 3 additional years of planned ET, c) no prior treatment with cyclin-dependent kinases 4/6 inhibitors or fulvestrant, and d) had surgery for their primary BC in the last 5 years...Pts with positive ctDNA without radiological disease progression (PD) will be allocated to 1 of the treatment arms (n=10): A) standard ET; B) giredestrant; C) giredestrant + abemaciclib; or D) giredestrant + inavolisib (if PIK3CA mutation)...Key secondary objectives include the proportion of pts with 90% decrease in baseline ctDNA at 6, 9, and 12 months, 70%, and 50% decrease in ctDNA at 3, 6, 9, and 12 months, and treatment safety and tolerability. A cohort expansion up to 20 pts in 1 or 2 arms will occur if at 3 months a 90% ctDNA decrease is observed in at least 30% of pts and if, after 3 additional months, a 90% ctDNA decrease is maintained in at least 20% of pts.

P=N/A; Not yet recruiting --> Recruiting | Trial completion date: Mar 2025 --> Jul 2026 | Trial primary completion date: Mar 2024 --> Jan 2026

"Foundation Medicine, Inc., and Natera, Inc., today announced the broad clinical launch of FoundationOne^®Tracker, a personalized tissue-informed circulating tumor DNA (ctDNA) test to monitor cancer patients’ response to therapy. FoundationOne Tracker is now available to all U.S. healthcare providers for treatment response monitoring (TRM). Additionally, the Centers for Medicare & Medicaid Services’ (CMS) Palmetto GBA Molecular Diagnostics Program (MolDX) has determined, effective June 17, 2023, that FoundationOne Tracker is covered for monitoring of response to immune-checkpoint inhibitor (ICI) therapy, for qualifying Medicare beneficiaries with all solid tumors. FoundationOne Tracker is also approved by the Clinical Laboratory Evaluation Program (CLEP) of New York, which is the only U.S. state that requires an independent regulatory review process for laboratory developed tests."

ctDNA monitoring during induction chemoIO can inform treatment outcomes in patients with advanced NSCLC. Importantly, monitoring remains feasible and informative for patients missing baseline ctDNA. ctDNA testing during induction chemoIO identifies patients at higher risk for disease progression and may inform patient selection for novel personalized maintenance or second line treatment strategies.

"Foundation Medicine, Inc., today announced that the company and its collaborators will present 21 abstracts demonstrating the value of high-quality tumor profiling tests to inform cancer care at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting from June 2-6 in Chicago."

On-treatment ctDNA monitoring during induction chemoIO can inform outcome on subsequent maintenance therapy in pts with advanced NSCLC. For pts with ctDNA+, prolonged induction chemoIO was not associated with improved outcomes. ctDNA testing during induction chemoIO may offer an opportunity to identify pts at higher risk for disease progression and inform selection for novel personalized maintenance treatment strategies.

P=N/A | N=103 | Not yet recruiting | Sponsor: Jules Bordet Institute | Initiation date: Dec 2022 --> Mar 2023

"Foundation Medicine, Inc and Natera...launched an early access program for clinical use of FoundationOne^®Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay. In addition, the investigational use only version of the test is now available for use in clinical trials...FoundationOne Tracker is now available through an early access program to a limited number of clinical customers, with plans to expand for broad availability in the United States later in 2023."

Node-negative rectal cancer exhibited ctDNA shed in a minority of pts, with most clearing ctDNA on chemotherapy before their TES. The dynamic ctDNA signal we demonstrate could supplement clinical factors in informing organ preservation in very early-stage rectal cancer. Larger studies are needed to determine if this information can be used to personalize therapy.

Our results indicate that MRD detection using the tissue CGP-informed ctDNA assay is prognostic of survival outcomes in patients with resected mCRC. The concurrent MRD detection and identification of actionable alterations has the potential to guide perioperative clinical decision-making.

P=N/A, N=103, Not yet recruiting, Jules Bordet Institute

"Foundation Medicine...announced that the U.S. Food and Drug Administration (FDA) has granted a Breakthrough Device designation for its circulating tumor DNA (ctDNA) detection and molecular monitoring assay, FoundationOne®Tracker. The assay uses optimized algorithms for identifying patient-specific variants and a personalized assay design that allows for the detection of ctDNA in plasma."

Tissue CGP-informed personalized MRD detection can detect low levels of residual ctDNA in patients with resected early stage bladder cancer, identifying a population with inferior DFS and OS. This technologic approach, synergizing regulatory-grade actionable CGP with ctDNA-based MRD detection, creates new opportunities for precision adjuvant therapy across a range of high-risk cancer types.

"Foundation Medicine, Inc. and Natera, Inc...today announced the launch of the research use version of FoundationOne® Tracker, Foundation Medicine’s personalized circulating tumor DNA (ctDNA) monitoring assay. FoundationOne Tracker uniquely combines Foundation Medicine’s tissue-based comprehensive genomic profiling (CGP) platform with Natera’s expertise in ctDNA monitoring."