COMPANY:

Hologic

"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."

"Hologic, Inc. (Nasdaq: HOLX), a global leader in women's health...has completed its previously announced acquisition of Mobidiag Oy, an innovator in near-patient, acute care molecular diagnostic testing, for an enterprise value of approximately $808 million."

"Hologic, Inc. (Nasdaq: HOLX) announced today that its subsidiary, Biotheranostics, Inc., has received broader Medicare coverage for its Breast Cancer Index™ test under an expanded Medicare Local Coverage Determination (LCD: L37822) effective today."

"Hologic, Inc...announced today that it has signed a definitive agreement to acquire Mobidiag Oy, a privately held, commercial-stage Finnish-French developer of innovative molecular diagnostic tests and instrumentation, for an enterprise value of approximately $795 million. This includes a cash payment of approximately $714 million (€600 million) for Mobidiag’s equity, and net debt of approximately $81 million."

"Hologic, Inc...has completed its previously announced acquisition of molecular oncology leader Biotheranostics, Inc. for approximately $230 million. Biotheranostics develops and markets two highly differentiated molecular diagnostic tests for breast and metastatic cancers – Breast Cancer Index™ (BCI) and CancerTYPE ID® (CTID)."

"Hologic, Inc…announced today a multi-year strategic collaboration with Google Cloud that will feature the integration of Google Cloud’s machine learning (ML) technologies with Hologic’s cutting-edge Genius™ Digital Diagnostics System to transform screening and accelerate the eradication of cervical cancer across the globe…Genius Digital Diagnostics is the first digital cytology platform to combine artificial intelligence (AI) with advanced digital imaging to help identify pre-cancerous lesions and cancer cells in women. Now, Hologic is enhancing the deep learning component of the system with Google Cloud."

"The National Comprehensive Cancer Network (NCCN) Panel expanded its clinical practice guideline for breast cancer by recognizing Breast Cancer Index as the only gene expression assay for prediction of benefit from extended endocrine therapy when considering adjuvant systemic therapy. The NCCN Guideline recommendation includes both node negative and node positive patients across anti-estrogen therapies, Tamoxifen and Aromatase Inhibitors based on data from the MA.17, Trans-aTTom and IDEAL clinical studies."

"Hologic, Inc…announced today it has completed the acquisition of SOMATEX Medical Technologies GmbH…for approximately $64 million. The company was previously owned by E-Med Solutions GmbH, Berlin, a group of investors led by German private equity company Westlake Partners. The transaction supports Hologic’s strategy to provide a comprehensive suite of innovative solutions across the continuum of breast health care. Specifically, SOMATEX’s differentiated products will enable Hologic to strengthen and further expand its breast marker portfolio, which has been growing consistently."

"Hologic, Inc…announced today that it has agreed to acquire Biotheranostics, Inc…for approximately $230 million, subject to working capital and other customary closing adjustments…Both of Biotheranostics’ tests are PCR (polymerase chain reaction)-based gene expression tests that have been extensively validated in large studies in areas of oncology with critical unmet needs and high growth potential. The BCI test is included in several clinical practice guidelines for breast cancer, and both tests enjoy widespread reimbursement in the United States…The acquisition is expected to be slightly dilutive to Hologic’s non-GAAP earnings per share in fiscal 2021, break-even in 2022, and accretive thereafter. The acquisition is expected to close in February of 2021, subject to antitrust clearance and other customary closing conditions."

"Hologic, Inc…today announced U.S. Food and Drug Administration (FDA) clearance and commercial availability of the Company’s Genius AI™ Detection technology, a new deep learning-based software designed to help radiologists detect subtle potential cancers in breast tomosynthesis images…The new technology represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius® 3D Mammography™ exam."

"Hologic, Inc...announced today that its new Genius™ Digital Diagnostics System is now CE marked in Europe. Genius Digital Diagnostics is the first digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced digital imaging to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women."

“Novel evidence demonstrating the ability of Breast Cancer Index to predict preferential endocrine response in distinct subgroups of HR+ early stage breast cancer patients will be premiered at ASCO 2020. The Investigation on the Duration of Extended Adjuvant Letrozole (IDEAL) trial examined the Breast Cancer Index (BCI) HOXB13/IL17BR ratio (H/I) and its ability to predict benefit from extended endocrine therapy….These findings add to the growing body of evidence demonstrating that Breast Cancer Index is the only commercially available genomic assay with predictive evidence to help inform the decision of extended endocrine therapy for HR+, early-stage breast cancer patients.”