Stratipath AB gained CE-IVD mark for its artificial intelligence (AI)-based software for prognostic risk stratification of breast cancers, clearing the path for introduction of the solution in the EU. Stratipath Breast analyzes digital histopathology whole slide images generated from surgically resected breast cancer tissue to identify patients with increased risk of disease progression. The system provides clearer guidance on the best treatment path for the 50% of women whose breast cancer is categorized as intermediate risk.

For a non-invasive cancer, ductal carcinoma in situ (DCIS) has spread rapidly—at least in research studies. Multiple companies presented results of diagnostic tests and genomic analysis that offer guidance for selecting treatment options for stage 0 breast cancer at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, which concluded in Chicago on June 7. Several of these studies reliably predicted which patients can safely be selected for active surveillance without surgery, who would benefit from endocrine or radiotherapy following surgery and who would be best served by risk-reducing surgery such as double mastectomy.

The “showdown” at the American Society of Clinical Oncology (ASCO) meeting foreseen by one analyst between breast cancer drugs from Gilead Sciences Inc. and Astrazeneca plc with partner Daiichi Sankyo Co. Ltd. didn’t quite materialize.

The “showdown” at the American Society of Clinical Oncology (ASCO) meeting foreseen by one analyst between breast cancer drugs from Gilead Sciences Inc. and Astrazeneca plc with partner Daiichi Sankyo Co. Ltd. didn’t quite materialize. Or the showdown happened, but turned out more nuanced than a one-to-one, high-noon gunfight on Main Street. Gilead ended considerable suspense June 4 by offering at ASCO phase III data from the Tropics-02 study with Trodelvy (sacituzumab govitecan), expectations for which already had grown lukewarm. Astrazeneca and Daiichi dazzled the next-day meeting with phase III data from the Destiny-Breast04 (DB04) study with Enhertu (fam-trastuzumab deruxtecan).

Variable expression of an enzyme in the initial tumor has been identified as an early step in the process of migration and growth of cells to form remote metastases in breast cancer.

Isono Health Inc. received FDA clearance for its Automated Three-dimensional Ultrasound with Artificial intelligence (ATUSA) system for breast imaging, a wearable, compact automated whole breast ultrasound system that can acquire high-quality images without requiring a skilled operator. The ultrasound scan takes two minutes to scan the entire breast volume and offers 3D visualization of the breast tissue.

The American Society of Clinical Oncology (ASCO) updated its guidelines to recommend use of Biotheranostics Inc.’ Breast Cancer Index (BCI) molecular gene-expression test to aid decisions on extended endocrine therapy in certain patients with the most common type of breast cancer.

Merit Medical Systems Inc. received FDA 510(k) clearance for the Scout Bx delivery system, which enables the placement during stereotactic and MRI-guided biopsy of a reflector to guide breast surgery. The delivery system works with the company’s Scout reflector, a wire-free radar localization device.

Myriad Genetics Inc. is launching a new suite of genetic tests designed for personalizing chemotherapy treatment. The Precise oncology offering includes Myriad’s precise tumor molecular profile test and two companion diagnostic tests, Mychoice CDx and Bracanalysis CDx. The company said the combination of germline, somatic and companion testing aims to maximize information for oncologists as they assign individual treatment plans. Results from each test are gathered as a single report accessed on an online portal.