COMPANY:

Hologic

"Hologic, Inc...today announced newly published study results revealing that use of the Breast Cancer Index (BCI) test led to physicians changing their long-term anti-estrogen treatment recommendations for 40% of patients with early-stage hormone receptor-positive (HR+) breast cancer. The results, which suggest that many women may be over- or undertreated without the incorporation of BCI, reflect real-world data from the largest prospective study assessing the impact of the BCI test on treatment decisions...Patients and physicians included in this study are participants in the BCI Registry Study....newly published findings reveal that when incorporated into routine clinical care, BCI has the potential to provide clinicians with greater confidence in their treatment recommendations, with 39% of providers saying they felt more confident in their recommendation for extended anti-estrogen therapy following BCI testing."

"Hologic, Inc...announced...that its new Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm has received clearance from the U.S. Food and Drug Administration (FDA), making it the first and only FDA-cleared digital cytology system that combines deep-learning-based artificial intelligence (AI) with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells."

"Hologic, Inc...and its subsidiary, Biotheranostics, Inc...announced new study data showing that the Breast Cancer Index test identified which premenopausal patients with early-stage, hormone-receptor positive (HR+) breast cancer benefited from the addition of ovarian function suppression (OFS) to primary adjuvant endocrine therapy...The translational study results are featured in the official press program at the 2022 San Antonio Breast Cancer Symposium (SABCS) being held from December 6-10, 2022."

"Hologic, Inc...announced....that the American Society of Clinical Oncology (ASCO) has published an update which expands the utility of Breast Cancer Index™ (BCI) within its Clinical Practice Guideline: 'Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer.' Specifically, ASCO now recognizes BCI as the only genomic test to help guide extended endocrine therapy decisions in early-stage, HR+ breast cancer patients with node negative or node positive (one-three positive nodes) disease when treated with five years of primary endocrine therapy without evidence of recurrence."

"Hologic, Inc...and its subsidiary, Biotheranostics, Inc., today announced new data demonstrating that Breast Cancer Index™ (BCI) not only predicts preferential recurrence-prevention benefit from extended endocrine therapy (EET), but also predicts the overall benefit/risk and likelihood of improved health outcomes from EET in certain hormone receptor positive (HR+) patients. New data also confirm two biomarkers used in BCI are interconnected molecular drivers of assessing recurrences in HR+ breast cancer. These findings were presented in Spotlight Sessions at the 2021 San Antonio Breast Cancer Symposium (SABCS), which is being held from December 7-10."

"Hologic, Inc...announced today that its new Genius™ Digital Diagnostics System is now commercially available in Europe. The Genius Digital Diagnostics System is the next generation of cervical cancer screening that combines deep learning-based artificial intelligence (AI) with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells in women. It was developed to provide actionable insights, and improve workflow and lab efficiency, all with one goal in mind – to eradicate cervical cancer."