Hologic Inc Stock Price, News & Analysis

Hologic, Inc. (Nasdaq: HOLX) received FDA approval for the Aptima® HIV-1 Quant Dx assay, making it the first dual-claim assay in the U.S. for HIV diagnosis and viral load monitoring. Previously approved for viral load monitoring in 2016, this molecular test operates on the Panther® system, providing reliable results across various HIV-1 groups. The approval is expected to enhance patient care by enabling immediate treatment initiation and assisting clinical labs in consolidating testing processes. There are around 1.2 million people living with HIV in the U.S.

Hologic, Inc. (Nasdaq: HOLX) announced the CE marking for its Genius™ Digital Diagnostics System, the first digital cytology platform integrating AI with advanced digital imaging. This innovative system enhances the detection of pre-cancerous lesions in cervical cancer screenings. Genius Digital Diagnostics allows for rapid analysis of ThinPrep Pap test slides, improving workflow and collaboration among pathologists. Hologic aims to redefine cervical cancer screening, offering a comprehensive solution from sample collection to digital diagnosis, positioning itself as a leader in women's health technology.

Hologic, Inc. reported robust fiscal Q4 2020 results, with revenues soaring 55.6% to $1.35 billion, driven primarily by COVID-19 testing demand. Organic revenue surged 72.5%, while worldwide Molecular Diagnostics revenue skyrocketed 375.8% to $818.9 million. GAAP EPS bounced back to $1.88, a significant improvement from a loss of $0.46 last year. The company also strengthened its portfolio with the acquisition of Acessa Health for approximately $80 million. Cash flow from operations hit $442 million, enabling debt reduction and share repurchases.

Hologic, Inc. (Nasdaq: HOLX) secured a $119 million contract from the U.S. government to enhance COVID-19 test production. This investment aims to boost capacity to 13 million tests monthly by January 2022. The Panther Fusion® and Aptima® SARS-CoV-2 Assays, which have FDA Emergency Use Authorization, enable rapid testing with results in about three hours. Hologic's manufacturing innovations and collaboration with federal entities like BARDA position the company to significantly meet public health needs during the pandemic.

Hologic, Inc. (Nasdaq: HOLX) has launched its 3DQuorum™ Imaging Technology, powered by Genius AI™, in Europe. This technology is designed to enhance mammography efficiency, addressing the backlog of breast screenings due to COVID-19 delays. The innovative system utilizes AI analytics to create high-resolution SmartSlices, significantly reducing the number of images for radiologists to review by two-thirds and saving them an hour of interpretation time daily. This advancement aligns with the European Commission's new guidelines promoting digital breast tomosynthesis as the standard for breast cancer screening.

Hologic, Inc. (Nasdaq: HOLX) will release its Q4 fiscal 2020 financial results on November 4, after market close. A conference call will follow at 4:30 p.m. ET, where management will discuss the results. Participants can listen by calling 888-204-4368 in the U.S. or +1 323-994-2093 internationally, using access code 9969459. A live webcast will be available on the company’s investor website. The call will be archived for 30 days. Hologic focuses on women's health through early detection and treatment.

Hologic (NASDAQ: HOLX) has received FDA authorization for its Aptima® SARS-CoV-2 assay, allowing testing for asymptomatic individuals. This follows a previous authorization for the Panther Fusion® SARS-CoV-2 assay. The CDC now recommends testing for individuals with recent contact with infected persons, enhancing the importance of Hologic's testing capabilities. The Aptima tests deliver results in approximately three hours and can process over 1,000 tests daily. Hologic has produced tens of millions of assays, securing a substantial role in global COVID-19 testing supply.

Hologic, Inc. (HOLX) has launched a multi-year initiative to reduce breast cancer screening disparities among Black women, partnering with the Black Women’s Health Imperative (BWHI) and RAD-AID. The program, introduced during Breast Cancer Awareness Month, aims to promote annual mammograms starting at age 40 and enhance access to screening technology in underserved communities. Research highlights that Black women face a 40% higher risk of dying from breast cancer. The effort addresses urgent needs exacerbated by COVID-19, seeking to mobilize resources to improve healthcare access.

Hologic, Inc. (Nasdaq: HOLX) has received Emergency Use Authorization (EUA) from the FDA for its Panther Fusion® SARS-CoV-2 assay, enabling testing for asymptomatic individuals. This is the first high-throughput molecular diagnostic test authorized for this purpose, aimed at identifying early infections and aiding in the reopening of schools and workplaces. The CDC's guidance supports testing for those exposed to the virus. Hologic plans to submit clinical evaluation results for further validation of its testing capabilities.