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New Evidence Backs Hologic’s AI-Powered Mammography Technology for Detecting Challenging Cancers

Business

New Evidence Backs Hologic’s AI-Powered Mammography Technology for Detecting Challenging Cancers
Business

Business

New Evidence Backs Hologic’s AI-Powered Mammography Technology for Detecting Challenging Cancers

2026-04-20 20:06 Last Updated At:04-21 12:58

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Apr 20, 2026--

New research on Hologic’s AI-driven breast cancer detection technologies, including a study focused on invasive lobular cancer, was presented at the Society of Breast Imaging (SBI) Symposium over the weekend in Seattle, Washington.

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“Invasive lobular cancers are more challenging to detect on a mammogram because of their unique characteristics,” said Mark Horvath, President of Breast & Skeletal Health Solutions at Hologic. “In the study, AI maintained high sensitivity for flagging these cancers, including some that had been interpreted as negative at a prior screening. These data add to a growing body of evidence that AI can act as a powerful supportive tool for radiologists as they review the full spectrum of breast cancers.”

In this retrospective, single-center study, researchers at Massachusetts General Hospital in Boston reviewed invasive lobular cancer cases diagnosed over a 10-year period and grouped them into two categories: those detected by a radiologist during a routine screening exam (195 total) and “false negatives” that were diagnosed within a year of a routine screening exam initially interpreted as negative (44 total). Researchers then used Hologic’s Genius AI ® Detection solution to retrospectively analyze all 239 cases. In this cohort, the technology identified and correctly localized close to 90% of the confirmed invasive lobular cancers. 1

New research suggests that, on average, 1 in 20 women worldwide will be diagnosed with breast cancer in their lifetime and, that if current rates continue, by 2050 there will be 3.2 million new breast cancer cases and 1.1 million breast cancer-related deaths per year. 2 About 10-15% of all breast cancers are invasive lobular cancers, 3 while ductal cancers that originate in the milk ducts of the breast — such as invasive ductal carcinoma and ductal carcinoma in situ — occur more commonly. Invasive lobular cancer arises in the milk-producing glands (lobules) of the breast and, because of its unique biology and tendency to grow in a linear pattern, it may be more challenging to see on mammography. This may lead to later detection and a more advanced stage at diagnosis.

The AI algorithm also identified 43% of the invasive lobular cancer cases initially interpreted during routine screening as negative. 1 Of note, as a retrospective analysis at a single institution, the study did not evaluate how use of AI in real time clinical practice would affect recall rates, biopsy outcomes or patient management.

Also at the Society of Breast Imaging Symposium, Hologic hosted a lunch and learn discussion with breast imaging experts focused on implementation of 3DQuorum ® imaging technology, which uses AI to reduce the number of 3D imaging “slices” radiologists need to review without compromising image quality, sensitivity or accuracy. 4,5

Study Limitations

The MGH study did not assess false-positive rates, recall rates or biopsy outcomes, and its single-center design may limit generalizability. AI performance was evaluated retrospectively and did not influence real-time radiologist decision-making; therefore, the observed gains represent a theoretical upper bound rather than a measured clinical impact. Additionally, the cohort included only patients with invasive lobular cancer, precluding comparison with other histologic subtypes.

About Genius AI Detection

Hologic’s Genius AI Detection solution is an innovative mammography screening technology designed to locate lesions likely to represent breast cancer. Suspicious areas are highlighted at radiologists’ workstations for concurrent reading to support smart, decisive interpretation. Hologic's deep learning algorithm is fed by the accumulation of a large, diverse patient base, providing rich insight and intelligence. For more information, please visit Genius AI Detection Technology.

About Hologic, Inc.

Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X,Instagram and YouTube.

Forward-Looking Statements

This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. 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 data or statements are based.

Hologic, The Science of Sure, Genius AI and 3DQuorum are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.

References

1. Lamb LR, Kim H, Do S, Bahl M. Artificial intelligence for the detection of invasive lobular carcinoma on screening digital breast tomosynthesis. Oral presentation, Society of Breast Imaging Symposium, Seattle, WA, April 2026.

2. Kim J, Harper A, McCormack V, et al. Global patterns and trends in breast cancer incidence and mortality across 185 countries. Nature Medicine. 2025;31(4). doi: https://doi.org/10.1038/s41591-025-03502-3.

3. DePolo J. Invasive Lobular Carcinoma (ILC). www.breastcancer.org. https://www.breastcancer.org/types/invasive-lobular-carcinoma.

4. Report: CSR-00116.

5. FDA Submission: P080003/S008.

Results highlight AI’s potential to aid radiologists in identifying diverse breast cancer subtypes, including invasive lobular cancer

Results highlight AI’s potential to aid radiologists in identifying diverse breast cancer subtypes, including invasive lobular cancer

TIVAT, Montenegro (AP) — Leaders from across the European Union and the Balkans are gathering in Montenegro on Friday to discuss expanding the bloc to include countries in the region, seen as a key area in countering security and economic threats posed by Russia and China.

The EU-Western Balkans summit, being held in the Adriatic Sea coastal town of Tivat, brings together European leaders including President Emmanuel Macron of France, German Chancellor Friedrich Merz and Italian Premier Giorgia Meloni, as well as the heads of other EU candidate countries in the Balkans and European Commission President Ursula von der Leyen.

High on the agenda will be Montenegro's EU accession: The bloc has already formed a working group to draft an accession treaty for the country, a signal that membership is within reach.

Adding members to the bloc to expand for more single market economic benefits and stronger security capabilities has gained increased urgency in recent years as the continent has faced a series of challenges, such as lopsided trade with China, migration pressures, the war in Ukraine and increasing hybrid threats from Russia.

The EU has signaled its commitment to expanding into the Western Balkans, where it has urged candidate countries such as Montenegro to carry out reforms like cutting corruption and shoring up democratic institutions — steps viewed as benefiting both the candidate nations and the EU as a whole.

Further, as wars rage in Ukraine, Iran and the Middle East, and Europe’s security has come under question with the United States viewed as less committed to its NATO allies, EU countries have pushed to boost their military capabilities to ward off future threats.

During a tour of countries in the Western Balkans this week, European Council President Antonio Costa, who is hosting the summit, has emphasized how serious the bloc is about enlarging.

Speaking in Serbia on Thursday after meeting with Serbian President Aleksandar Vucic, Costa said the EU would look for new ways to speed up the membership process for the Western Balkan candidate countries.

In times of “global geopolitical uncertainty and economic instability,” Costa said, enlarging the EU is “not just an opportunity. It is a geostrategic necessity for Europe.”

Montenegro, a small, mountainous country that was once a part of Yugoslavia and which this week marked the 20th anniversary of its independence from a union with neighboring Serbia, is considered a front-runner ahead of the region’s other candidate countries of Albania, Bosnia-Herzegovina, Serbia, Kosovo and North Macedonia.

After joining NATO in 2017, the country of 623,000 people is now set on fulfilling an ambitious agenda of becoming the 28th member of the EU in 2028. The motto “28 by 28” has even been inscribed on one of the planes of Montenegro’s national airline.

Candidate countries must bring their laws into line in 35 policy areas or “chapters,” ranging from justice standards to farm and fishing rules. All 27 EU members must agree before each chapter can be opened, and then again for it to be closed.

Ukraine and Moldova are also among about 10 countries aspiring to join the bloc. Iceland will hold a referendum in August on whether to apply.

Faruk Bašić, a researcher at the Brussels Institute for Geopolitics, said the summit will likely result in a rapid movement for Montenegro to join the bloc in 2028. It will also likely see new safeguards to ensure member nations don’t break EU norms.

The summit will be the first to bring together EU leaders since the stunning defeat in April of Viktor Orbán, Hungary’s former Russia-friendly prime minister who, during his 16-year rule, flouted the EU’s standards on democracy and the rule of law and forged close ties with other autocrats.

With the painful experience of Orbán’s democratic backsliding and historic use of the veto in the European Council, the EU is devising new ways to use financial penalties or restricted access to the single market to pressure incoming nations to carry out reforms and adapt to the bloc's standards, Bašić said.

“The EU is trying to find a way how to admit a country that isn’t fully ready to be admitted without losing the ability to hold it accountable after the fact,” he said, pointing to Ukraine’s accession bid as well as nations in the Western Balkans like Serbia and Kosovo.

McNeil reported from Brussels.

French President Emmanuel Macron, left, speaks during a press conference after talks with Montenegro's President Jakov Milatovic, right, in Cetinje, Montenegro, Thursday, June 4, 2026. (AP Photo/Risto Bozovic)

French President Emmanuel Macron, left, speaks during a press conference after talks with Montenegro's President Jakov Milatovic, right, in Cetinje, Montenegro, Thursday, June 4, 2026. (AP Photo/Risto Bozovic)

French President Emmanuel Macron, left, reviews the honor guard with Montenegro's President Jakov Milatovic during a welcome ceremony in Cetinje, Montenegro, Thursday, June 4, 2026. (AP Photo/Risto Bozovic)

French President Emmanuel Macron, left, reviews the honor guard with Montenegro's President Jakov Milatovic during a welcome ceremony in Cetinje, Montenegro, Thursday, June 4, 2026. (AP Photo/Risto Bozovic)

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