Hologic's HPV Test Receives FDA Approval
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 04 2026
0mins
Should l Buy HOLX?
Hologic announced that its Aptima HPV Assay received FDA approval for clinician-collected HPV primary screening. Hologic's human papillomavirus test is the only FDA-approved mRNA-based assay, designed specifically to detect infections most likely to lead to cervical cancer.
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Analyst Views on HOLX
Wall Street analysts forecast HOLX stock price to rise
12 Analyst Rating
0 Buy
12 Hold
0 Sell
Hold
Current: 75.550
Low
76.00
Averages
77.56
High
79.00
Current: 75.550
Low
76.00
Averages
77.56
High
79.00
About HOLX
Hologic, Inc. is a medical technology company primarily focused on improving women's health and well-being through early detection and treatment. The Company is a developer, manufacturer and supplier of diagnostics products, medical imaging systems, and surgical products. Its segments include Diagnostics, Breast Health, GYN Surgical, and Skeletal Health. The Diagnostics segment offers a range of diagnostic products, which are used primarily to aid in the screening and diagnosis of human diseases. The Breast Health segment offers a broad portfolio of solutions for breast imaging, biopsy, breast surgery and pathology. The GYN Surgical segment's products include MyoSure hysteroscopic tissue removal system, NovaSure endometrial ablation system, Acessa ProVu laparoscopic radiofrequency ablation system, as well as CoolSeal vessel sealing portfolio and JustRight surgical stapler. The Skeletal Health segment's products include the Horizon DXA and the Fluoroscan Insight FD mini C-arm.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- FDA Approval: Hologic's Aptima® HPV Assay has received FDA approval, becoming the only mRNA-based HPV test, designed to enhance flexibility and choice in cervical cancer screening, which is expected to significantly improve screening efficiency for clinicians.
- Importance of Screening: It is estimated that by 2026, approximately 13,490 new cases of cervical cancer will be diagnosed in the U.S., with about 4,200 women dying from the disease; Hologic's testing can reduce these preventable deaths through early screening and timely follow-up.
- Clinical Research Support: The approval is based on one of the largest real-world HPV screening studies involving over 650,000 women, showing that the sensitivity of the Aptima HPV Assay is clinically comparable to that of an FDA-approved DNA-based HPV test, further enhancing its credibility in clinical applications.
- Diverse Screening Options: Hologic's portfolio now includes Pap + HPV co-testing, Pap testing, and HPV primary testing, providing multiple FDA-approved screening methods that help physicians select the most appropriate testing approach based on patient age and risk factors.
See More
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- Earnings Miss: Hologic reported a Q4 non-GAAP EPS of $1.04, missing expectations by $0.06, indicating pressure on profitability that could undermine investor confidence.
- Flat Revenue: The company’s Q4 revenue stood at $1.05 billion, flat year-over-year but $20 million below market expectations, reflecting weak market demand that may impact future growth strategies.
- Challenging Outlook: Hologic indicated that the outlook for 2026 is more challenging due to halted product shipments, which could lead to a decline in market share, necessitating a reassessment of product lines and market strategies to address these challenges.
- Analyst Rating Watch: Following the earnings miss, analysts' quant ratings on Hologic may be affected, prompting investors to monitor subsequent rating changes to adjust their investment strategies.
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