Hologic's BCI Test Shows Growing Impact in Endocrine Therapy Decisions

Hologic’s HOLX acquisition of Biotheranostics in 2021 accelerated its entry into a large, fast-growing oncology adjacency. The business also carries higher margins than the company’s legacy service business. Among Biotheranostics’ proprietary laboratory-developed tests is the Breast Cancer Index — the only test recognized by major clinical practice guidelines that predicts which early-stage, HR+ breast cancer patients are likely to benefit from extended endocrine therapy. The test, however, is intended for routine clinical use and has not been cleared or approved by the FDA.

At the 2025 San Antonio Breast Cancer Symposium (SABCS), Hologic and Biotheranostics will present 11 studies featuring the BCI Test. These new insights explore potential expanded utility in premenopausal women and comparison to the 21-gene assay for extended endocrine therapy treatment decisions, as well as highlight the consistency of the test’s performance across diverse patient subgroups and sample types. Findings also support the company’s ongoing commitment to help inform personalized treatment recommendations.

Earlier this year, Hologic also presented an analysis of the prospective, multi-center BCI Registry at the 2025 American Society of Clinical Oncology Annual Meeting.  Data from a comprehensive assessment of more than 2,800 patients showed that the BCI testing led to a change in treatment recommendations for about four in 10 cases. Importantly, physician confidence in treatment recommendations also increased, and patients reported feeling more comfortable with their treatment decisions, citing fewer concerns about cost, drug safety and preference related to extended endocrine therapy benefit.

For the past several quarters, Biotheranostics has continued to deliver accretive growth to Hologic’s Molecular Diagnostics business, supported by the continued adoption and expanded coverage for the BCI test.

New Updates From Hologic's Competitors

Medtronic MDT has secured FDA clearance for its Hugo robotic-assisted surgery system for use in urologic surgical procedures. The development brings a versatile robotic-assisted platform to U.S. surgeons and health systems seeking to expand soft-tissue robotic surgery programs and access to minimally invasive care. Additionally, Medtronic has also begun a broad U.S. commercial launch of the MiniMed 780G integrated with Abbott’s Instinct sensor, following the system’s FDA clearance earlier this year to enable sensor integration.

Becton, Dickinson and Company BDX announced the global commercial release of new configurations of cell analyzers, featuring breakthrough spectral and real-time cell imaging technologies. This will enable more labs in academia, pharma and biotech – across scales, needs and budgets – to advance discoveries in immunology, cancer immunotherapy and cell biology. Additionally, BDX marked the European launch of the BD Surgiphor Surgical Wound Irrigation System, the first of its kind to receive CE approval.

HOLX’s Stock Performance, Valuation & Estimates

In the past six months, Hologic shares have gained 18.9% compared to the industry’s 14% growth.

Valuation-wise, Hologic is trading at a forward five-year price-to-sales (P/S) of 3.87X, lower than the industry average of 4.39X.

See how analysts are projecting Hologic’s fiscal 2025 and 2026 earnings.

HOLX stock currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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This article originally published on Zacks Investment Research (zacks.com).

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