CE-IVDR Mark for Hologic’s Aptima® HPV Test Expanded to Include Self-Collected Sample Claim in Cervical Cancer Screening

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Jul 14, 2026--

Hologic, Inc. announced today that its Aptima ® HPV Assay received an expanded CE-IVDR marking in the European Union and the UK and is now approved for self-collected vaginal samples using the Aptima Multitest Specimen Collection Kit.

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Cervical cancer is the fourth most common cancer in women but is largely preventable through HPV vaccination and regular screening. 1 Evidence shows that organized screening and early detection reduces deaths from cervical cancer, with mortality reduction rates in Europe ranging from 41% to 92%. 2 However, even in countries with an established cervical screening program, screening participation rates vary widely, from 25% to 80%, with some showing stagnation or decline in recent years. 3

“Despite the benefits of cervical cancer screening, there are still barriers to participation. Some women do not participate for psychosocial, cultural, economic or access reasons,” said Andrew Pieprzyk, Vice President, Strategic Development, Diagnostics, International at Hologic. “Expanding our CE mark for the Aptima HPV Assay to include self-collection in a healthcare setting offers women an alternative method of screening and has the potential to improve screening participation rates.”

While self-sampling has the potential to increase HPV screening rates in under-screened populations, clear follow-up steps are essential for patients with positive results. Because self-collected samples are vaginal samples, further evaluation following a positive result may require a clinician-collected cervical sample to guide appropriate clinical management, including any additional testing or treatment. 4 The impact of screening depends on timely connection to follow-up care for those who need it.

Hologic is dedicated to improving women’s health, particularly through cervical cancer screening and early detection. From the introduction of the ThinPrep ® Pap test to the launch of the ThinPrep Imaging System, Aptima HPV Assay and most recently the Genius TM Digital Diagnostics System, Hologic continues to innovate in the cytology space to support laboratories, healthcare providers and patients alike.

Hologic’s Aptima HPV Assay was CE marked in the European Union in accordance with the In Vitro Diagnostic Regulation, which is also recognized by other countries around the world.

Commercialization will be announced on a country-by-country basis. This indication is currently not available in the United States.

To learn more about the Aptima HPV Assay, visit here.

About Hologic

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. For more information on Hologic, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube.

Forward-Looking Statements

This press release may contain forward-looking information that involves risks and uncertainties. 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. The actual effect of the use of the products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. 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 statements are based.

Hologic, Aptima, ThinPrep and Genius are trademarks or registered trademarks of Hologic, Inc. in the United States and/or other countries.

CE 2797 Notified Body number wherever applicable.

 

Hologic’s Aptima® HPV Assay and Aptima Multitest Specimen Collection Kit

WASHINGTON (AP) — JPMorgan Chase said Tuesday that it logged $16.9 billion in second-quarter profit as its equities trading division again took advantage of market volatility triggered by the war in Iran.

The nation's largest bank by asset size, JPMorgan said that revenue in every line of its business hit record levels in the quarter, including its markets division, where revenue grew 35% over the same period last year. Revenue in its equity markets division skyrocketed 86%.

JPMorgan earned $6.14 per share in the period, beating analyst estimates of $5.59 per share and 2025's $5.24. Managed revenue came in at $58 billion, also topping the estimates of analysts surveyed by FactSet.

JPMorgan shares were down 2.4% before the opening bell.

CEO Jamie Dimon said that revenue from the New York bank's investment banking division rose 30%, accelerating to the highest level since 2021 as the thirst for initial public offerings and mergers and acquisitions remained strong.

Investment research analysts are forecasting that both merger and acquisitions and IPOs to continue at a blistering pace through 2026.

While volatile markets can cause anxiety for individual investors, high-speed Wall Street trading desks can take advantage of the wild gyrations. Big swings in markets tend to increase activity on trading desks, leading to higher commissions and fee revenue for the banks.

Wells Fargo also reported its second-quarter results on Tuesday, posting a 22% jump in net income over the same period last year. Wells said it earned $6.4 billion in the period, or $2 per share, up from $5.5 billion a year ago. Revenue of $22.6 billion also topped estimates.

Wells CEO Charlie Scharf said the San Francisco bank was benefiting from a strong economy and its newly unleashed ability to invest after years of government oversight. Wells’ said its investment banking revenue grew 20% from last year and markets revenue was up 24%.

“After years of not being on a level playing field with our competitors because we couldn’t grow our balance sheet, we are carefully deploying capital to grow and support our clients by taking risks that we think are prudent through economic cycles, not just the strong environment we see today,” Scharf said.

Shares of Wells Fargo fell 1.8% in premarket.

FILE - The Bank of America logo is seen on a branch office, Oct. 14, 2022, in Boston. (AP Photo/Michael Dwyer, File)

FILE- In this May 17, 2018, file photo the logo for Wells Fargo appears above a trading post on the floor of the New York Stock Exchange. (AP Photo/Richard Drew, File)

FILE - In this Monday, Oct. 21, 2013, file photo, the JPMorgan Chase & Co. logo is displayed at their headquarters in New York. (AP Photo/Seth Wenig, File)