Hologic Completes Acquisition of Biotheranostics, Enabling Entry into Growing Oncology Market

“We are very pleased to complete the acquisition of Biotheranostics and look forward to working with our new colleagues to grow in the large, rapidly expanding oncology space,” said Kevin Thornal, Hologic’s president, Diagnostic Solutions Division. “We are even more excited about the acquisition because last month the National Comprehensive Cancer Network revised its clinical practice guidelines to include Breast Cancer Index as the only gene expression assay to predict benefit from extended endocrine therapy for patients with early-stage hormone-receptor positive breast cancer.”

The National Comprehensive Cancer Network^® (NCCN^®) is a not-for-profit alliance of 30 leading cancer centers. Breast Cancer Index is recommended by the NCCN for prediction of which early-stage hormone receptor positive (HR+) breast cancer patients are likely to benefit from extended endocrine therapy.¹ Terminating endocrine therapy in those patients unlikely to benefit may save healthcare dollars and reduce patient exposure to challenging side effects of therapy. Conversely, for patients needing prolonged treatment, Breast Cancer Index can provide the confidence of knowing that the treatment is reducing their risk of recurrence. The BCI test is also included in additional clinical practice guidelines for breast cancer, including those from the American Society for Clinical Oncology (ASCO).²

Biotheranostics also developed and markets the CancerTYPE ID test, which provides a molecular diagnosis for patients with uncertain or unknown cancers. In advanced cancer that has metastasized, it can be difficult to determine the tumor type and subtype, information that is needed to optimize treatment selection, particularly with advancements in molecular targeted therapies. CTID compares genomic tumor information to a reference database to find the closest match, enabling physicians to design personalized treatment plans for patients with Unknown Primary Cancer and cases with diagnostic ambiguity.

The BCI and CTID tests are laboratory developed tests that are not required to be cleared or approved by the US Food and Drug Administration.

About Hologic, Inc.

Hologic, Inc. is an innovative medical technology company primarily focused on improving women’s health and well-being through early detection and treatment. For more information on Hologic, visit www.hologic.com.

Hologic and The Science of Sure are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. Breast Cancer Index and CancerTYPE ID are trademarks and/or registered trademarks of Biotheranostics, Inc.

Forward-Looking Statements

This news release contains forward-looking information that involves risks and uncertainties, including statements about Hologic’s plans, objectives, expectations and intentions for Biotheranostics. Such statements include, without limitation: financial or other information based upon or otherwise incorporating judgments or estimates relating to future performance, events or expectations; strategies, positioning, resources, capabilities, and expectations for future performance; and Hologic’s outlook and financial and other guidance. These forward-looking statements are based upon assumptions made as of this date and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated.

Risks and uncertainties that could adversely affect business and prospects, and otherwise cause actual results to differ materially from those anticipated, include without limitation: the possibility that the anticipated benefits from the transaction cannot be fully realized or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of Biotheranostics’ operations with those of Hologic will be greater than expected; the ability of Hologic and Biotheranostics to retain and hire key personnel; the coverage and reimbursement decisions of third-party payers and the guidelines, recommendations, and studies published by various organizations relating to the use of products and treatments; the ability to successfully manage ongoing organizational and strategic changes, including Hologic’s ability to attract, motivate and retain key employees; the development of new competitive technologies and products; regulatory approvals and clearances for products; the anticipated development of markets in which products are sold into and the success of products in these markets; the anticipated performance and benefits of products; estimated asset and liability values; and anticipated trends relating to Hologic’s financial condition, results of operations or capital resources.

The risks included above are not exhaustive. Other factors that could adversely affect Hologic’s business and prospects are described in Hologic’s filings with the SEC. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such statements are based.

References:

1. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed February 4, 2021.
2. https://www.asco.org/sites/new-www.asco.org/files/content-files/practice-and-guidelines/2019-adj-biomarkers-summary-table.pdf. Accessed February 4, 2021.

Source: Hologic, Inc.

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