Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®Liquid CDx to be used as a companion diagnostic for Itovebi™ (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.
Artificial intelligence firm Stratipath announced Monday that it has entered into a nonexclusive collaboration with Roche to distribute Stratipath's breast cancer risk stratification digital pathology solution.
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced certification for its Guardant360® CDx blood test under the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746). The certification from TÜV SÜD Product Service is for tumor mutation profiling in patients with any solid cancerous tumor and for companion diagnostic indications to identify patients who may benefit from certain targeted therapies for advanced non-small cell lung cancer and breast cancer.
UK-based liquid biopsy firm Angle said Tuesday that it inked an agreement with drug firm Eisai to conduct a pilot study on the use of Angle's HER2 assay to guide treatment of breast cancer patients with HER2-expressing solid tumors.
Today GE HealthCare (Nasdaq: GEHC) announced the release of a new, all-in-one platform of artificial intelligence (AI) apps to support clinicians with breast cancer detection and improved workflow productivity called MyBreastAI Suite.
Foundation Medicine Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for AstraZeneca’s Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant) which has been contemporaneously approved for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (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.
Natera on Thursday announced a new study within the Phase II I-SPY 2 trial that will evaluate the ability of its Signatera minimal residual disease test to monitor breast cancer patients' response to neoadjuvant therapy.
Ibex Medical Analytics (Ibex) has launched a breast cancer biomarker scoring tool powered by artificial intelligence (AI) to help clinicians with treatment decisions.
Paige is enhancing its suite of AI-enabled solutions designed to support pathologists in the diagnosis of breast cancer while decreasing subjectivity and the tedium of manual analysis.
Breast Cancer Canada said on Thursday that it has launched a new grant program in collaboration with AstraZeneca Canada and Illumina.
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