How Hologic tapped AI and volumetric imaging for cervical cytology — and potential applications beyond

Hologic designed its Genius cytology technology for more efficient and accurate review of cervix cell samples — and there’s more to come.

Hologic says its Genius cytology technology reduces false negatives of high-grade squamous intraepithelial and more severe lesions by 28% compared to microscopic review. [Photo courtesy of Hologic]

Hologic‘s Genius cytology system uses new scanning technology and artificial intelligence to flag cervical cancer cells and pre-cancerous lesions.

Hologic won a de novo classification in January 2024 for its Genius Digital Diagnostics System and Genius Cervical AI algorithm for cervical cytology. Besides replacing Hologic’s ThinPrep Imaging System — used for the majority of cervical cancer screenings in the U.S. — the technology behind the Genius system could one day also help screen for other kinds of cancer like bladder cancer as well as infectious organisms, Ho…

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FDA clears new cervical cytology AI tech from Hologic

The Genius digital diagnostics system. [Image courtesy of Hologic]Hologic (Nasdaq: HOLX) + announced that the FDA granted clearance for its Genius digital diagnostics system with the Genius cervical AI algorithm.

Clearance makes Genius the first and only FDA-cleared digital cytology system combining deep learning-based AI with advanced volumetric imaging technology to help identify pre-cancerous lesions and cervical cancer cells, according to a news release.

Hologic’s clearance comes within days of a new partnership between BD and Techcyte on AI-based cervical cytology guidance.

Screenings for cervical cancer include a pap test. Generally, a sample is collected at an OB-GYN office and the cervical cells are sent to a lab and transferred to a glass slide. Then, it goes under a microscope. Instead, Genius digitally images the glass slides and applies an AI algorithm to pinpoint cells that cytologists and pathol…

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Hologic promotes from within to fill COO spot

Essex Mitchell. [Image from Hologic]Hologic (NYSE: HOLX) + announced that it promoted Essex Mitchell to the role of chief operating officer, effective Jan. 1, 2024.

Mitchell, 44, originally joined Hologic in September 2017 as VP of sales and commercial excellence for the GYN surgical decision. He currently serves as president of GYN surgical solutions, a post he assumed in August 2020. Mitchell brings almost 20 years of medical device and pharmaceutical experience to the COO spot at Hologic.

From September 2006 to September 2017, he held various commercial roles of increasing responsibility at Stryker. Mitchell led Stryker’s sales and marketing efforts across multiple divisions during his tenure. Prior to his medtech career, Mitchell played professional football in both the National and Canadian Football leagues.

In connection with his promotion, the Hologic board approved an increase in Mitchell’s base…

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Hologic launches global outreach partnership for Breast Cancer Awareness Month

[Image courtesy of Hologic]Hologic (Nasdaq: HOLX) + today announced a series of activities for October — Breast Cancer Awareness Month.

The slate of activities promotes the importance of breast cancer screenings. It includes a global partnership with Know Your Lemons, a non-profit committed to improving early breast cancer detection. Know Your Lemons provides creative and empowering education on the topic.

Marlborough, Massachusetts-based Hologic kicks things off on Oct. 2. Steve MacMillan, chair, president and CEO, will wring the Nasdaq opening bell that day. Hologic employees, plus tennis legend and two-time breast cancer survivor Martina Navratilova, will join MacMillan.

“For the past 17 years, Hologic has rung the Nasdaq bell at the start of Breast Cancer Awareness Month to draw attention to the impact breast cancer has on our communities and to highlight the enduring need for broader awareness about the critic…

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Hologic, Bayer partner on improved mammography imaging

Hologic (Nasdaq: HOLX) + and Bayer today announced an international partnership focused on improving breast cancer detection.

The companies teamed up to deliver contrast-enhanced mammography (CEM) solutions across Europe, Canada and Asia Pacific. CEM, a highly sensitive, relatively low-cost breast imaging modality combines digital mammography with contrast agent administration. It supports breast cancer diagnosis and guides treatment decisions.

Marlborough, Massachusetts-based Hologic said the partnership brings together its mammography gantries with Bayer’s CEM-approved injection systems. It enables the administration of contrast media during a mammography examination, according to a news release. The agreement allows the companies to support radiologists with a comprehensive product package and hands-on training.

“Over the past several years, we’ve seen an increased interest in contrast-enhanced mammogra…

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Hologic stock dips on Q3 losses, questions over future margins

Hologic (Nasdaq: HOLX) + shares fell this morning despite third-quarter results that topped the consensus forecast.

Shares of HOLX dipped 4% at $76.29 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell 0.6%.

The Marlborough, Massachusetts-based women’s health and diagnostics company posted losses of $40.5 million. That equals 16¢ per share on sales of $984.4 million for the three months ended July 1, 2023.

Hologic recorded a bottom-line slide into the red from profits of $228.4 million for the same period a year ago. It reported a sales decline of 1.8%, primarily driven by lower sales of COVID-19 assays compared to last year. Revenues still exceeded Hologic’s guidance for between $930 million and $980 million.

Adjusted to exclude one-time items, earnings per share came in at 93¢, landing 4¢ …

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The top IVD innovation news stories of 2023 — so far

[Image courtesy of the National Cancer Institute via Unsplash]This year is proving to be another important year for innovation in the in vitro diagnostic (IVD) space.

According to the FDA, IVD devices are tests performed on samples taken from the human body. They could be everything from blood tests processed in labs to home COVID-19 or pregnancy tests to continuous glucose monitors using tiny sensors stuck under to skin to measure blood glucose — and much more.

Here are five IVD innovation stories that have caught our attention so far this year:

5. Hologic wins FDA clearance for COVID-flu-RSV assay

Last winter, the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV. So it was welcome news in May when Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.

Read the full story a…

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Illumina’s CEO resigns, MacMillan expresses confidence

Illumina Inc. (NASDAQ: ILMN) announced that CEO Francis deSouza has resigned from the DNA sequencing and array-based tech developer.

The news, announced yesterday, comes more than a week after Hologic CEO Stephen MacMillan became non-executive board chair. Edwards Lifesciences CFO Scott Ullem filled a second new seat, bringing the board seat total to 12.

Illumina experienced some board changes after activist investor Carl Icahn’s candidate knocked the previous board chair John Thompson out of his position, though deSouza was able to survive his own Icahn-supported challenge.

“We thank Francis for his contributions and leadership, and are very excited about embarking on the next chapter of Illumina’s great journey,” MacMillan said in a news release. “Illumina’s technology remains at the forefront of DNA sequencing and has continued to set the pace for the industry. We are confident Illumina can continue to execute on it…

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Hologic CEO MacMillan to chair Illumina’s board

Hologic CEO Stephen MacMillan

Illumina (NASDAQ: ILMN) announced today that its board has elected Hologic CEO Stephan MacMillan to fill a new seat and become its non-executive chair.

Edwards Lifesciences CFO Scott Ullem will fill a second new seat — bringing the number of board seats to 11 at the San Diego–based DNA sequencing and array-based tech developer.

The move comes a week after activist investor Carl Icahn’s nominee — Andrew Teno — knocked out previous board chair John Thompson in a shareholder vote. CEO Francis deSouza survived another challenge from an Icahn-backed nominee.

“Both Steve and Scott collectively bring more than 30 years of experience in healthcare, and the appointments are part of our continual process to attract strong independent directors. We believe these two extremely talented business executives will help broaden the skills of the current Board, especially in the fields of corporate finance and international expans…

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Hologic wins FDA clearance for COVID-flu-RSV assay

Tge Panther Fusion SARS-CoV-2/Flu A/B/RSV assay [Image courtesy of Hologic]Hologic (Nasdaq: HOLX) + today announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.

The clearance comes after a winter in which the U.S. and other countries dealt with a “tripledemic” of COVID-19, influenza, and RSV.

“This past winter, we saw several respiratory illnesses — COVID, flu and RSV — spreading simultaneously throughout communities and often presenting with similar symptoms, making diagnoses difficult,” Hologic Diagnostic Solutions President Jennifer Schneiders said in a news release.

“While we are out of the respiratory virus season this year, accurate viral diagnosis remains a high priority for clinicians for the upcoming respiratory season, and we are committed to advancing COVID and respiratory diagnostics on our Panther Fusion system. This test will be a critical tool to help determine…

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Hologic turns to Eagles rookie Kelee Ringo and his mom to raise mammograms awareness

A screenshot from a video announcing a partnership between Hologic and NFL player Kelee Ringo. From left, Dr. DaCarla Albright, Tralee Hale, Kelee Ringo. [Image from Hologic]Hologic (Nasdaq:HOLX) today announced a new partnership with recently drafted NFL quarterback Kelee Ringo and his mother.

The partnership with Ringo and his mother, breast cancer survivor Tralee Hale, aims to provide education around breast health. That includes the importance of prioritizing annual mammograms and other key health screenings.

Last month, the Philadelphia Eagles drafted Ringo, a two-time national champion out of the University of Georgia. Ringo, Hale and Hologic timed the launch of their partnership around Mother’s Day and National Women’s Health Week this week.

According to a news release, Hale spent time focused on managing her family, career and other commitments, failing to prioritize preventive care screenings. As a single mother, she received a breast c…

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Hologic beats The Street in Q2, raises guidance

Hologic (Nasdaq:HOLX) +  today posted second-quarter results that topped the consensus forecast despite dipping COVID-19-related sales.

The Marlborough, Massachusetts-based women’s health and diagnostics company posted profits of $218.5 million. That amounts to 87¢ per share on sales of $1.03 billion for the three months ended April 1, 2023.

Hologic posted a 52% bottom-line slide on a sales decline of 28.5%. Significantly lower sales of COVID-19 assays — as expected — drove the declines. However, revenue still topped the company’s guidance range of $930 million to $980 million. Plus, excluding COVID-19-related revenues, total organic revenue grew by 20.2%.

Adjusted to exclude one-time items, earnings per share came in at $1.06. That landed 18¢ ahead of projections on Wall Street. Sales posted a beat, too, as analysts expected $958.8 in revenues.

Excluding COVID-19 sales, diagnostic revenues ticked up…

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