Tag Archives: Foundation Medicine

December 2023—Foundation Medicine has received FDA approval for its FoundationOne CDx to be used as a companion diagnostic for capivasertib (Truqap, AstraZeneca) in combination with fulvestrant, which has been contemporaneously approved for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.

Dec. 28, 2022—The FDA has approved Foundation Medicine's FoundationOne Liquid CDx as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitutions and are appropriate for treatment with a group of tyrosine kinase inhibitors approved by the FDA for this indication

January 2021—The Food and Drug Administration approved the next -generation sequencing­­­–based FoundationOne CDx test (Foundation Medicine) as a companion diagnostic to identify fusions in neurotrophic receptor tyrosine kinase genes NTRK1, NTRK2, and NTRK3 in DNA isolated from tumor tissue specimens from patients with solid tumors eligible for treatment with larotrectinib (Vitrakvi, Bayer Healthcare Pharmaceuticals).

February 2020—Foundation Medicine has received FDA approval for its FoundationOne CDx to be used as a companion diagnostic for Piqray (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor–positive, human epidermal growth factor receptor 2–negative, PIK3CA-mutated advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.

May 2018—Foundation Medicine announced that FoundationOne CDx, an FDA-approved comprehensive genomic profiling assay for all solid tumors incorporating multiple companion diagnostics, is available in the United States. FoundationOne CDx is a test for patients with advanced cancer and is offered as a nationally covered benefit across all solid tumors for Medicare and Medicare Advantage beneficiaries who meet eligibility requirements.

April 17, 2018—Foundation Medicine announced that its FoundationOne CDx, an FDA-approved comprehensive genomic profiling assay for all solid …

July 2016—Foundation Medicine has launched an analytically validated and accurate blood-based circulating tumor DNA assay that provides patients and oncologists with a new option for comprehensive genomic profiling when a tissue biopsy is not feasible or when tissue is not available.

February 2016—Foundation Medicine announced a three-way collaboration with Horizon Healthcare Services and Clinical Outcomes Tracking and Analysis to advance precision medicine, improve clinical outcomes, and deliver enhanced value to the health care system in the treatment of patients with metastatic non-small cell lung cancer.

October 2015—A decade later, online laboratory handbook gets makeover: Ten years ago, when Massachusetts General Hospital created an online laboratory handbook, the event crowned many hours of programming and coding by a team of pathologists, who were convinced their labors would dramatically streamline access to information.