Tag Archives: Hologi

Feb. 2, 2024—Hologic announced that its Genius Digital Diagnostics system with the Genius Cervical AI algorithm has received clearance from the FDA, making it the first FDA-cleared digital cytology system that combines deep-learning–based artificial intelligence with advanced volumetric imaging technology to help identify precancerous lesions and cervical cancer cells.

June 2023—Hologic announced the FDA has granted 510(k) clearance for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. This molecular diagnostic test, previously under EUA, detects and differentiates SARS-CoV-2, influenza A and B, and respiratory syncytial virus. It runs on the Panther Fusion system, which provides initial results in about three hours and can process more than 1,000 tests in 24 hours.  

May 24, 2023—Hologic announced the FDA has granted 510(k) clearance for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay.

Feb. 21, 2023—BD announced FDA market approval for the Onclarity HPV assay to be used with the Hologic ThinPrep Pap test.

December 2022—Hologic has been awarded a $19 million contract from the Biomedical Advanced Research and Development Authority. The funding will help bring Hologic’s Panther Fusion SARS-CoV-2/Flu A/B/RSV and Aptima SARS-CoV-2 assays in line with the FDA’s in vitro diagnostic standards and support clinical efforts to obtain claims for nasal samples using the Panther Fusion as well as market authorization for COVID-19 testing of asymptomatic individuals who have reason to be tested. The Aptima SARS-CoV-2 assay received EUA in May 2020, and the CE-marked Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is under development in the United States. The project has been funded with federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and BARDA.

Oct. 29, 2021—Hologic announced that its Aptima SARS-CoV-2/Flu assay is available for the simultaneous detection and differentiation of three respiratory viruses that can present with overlapping clinical symptoms.

May 24, 2021—Hologic announced the FDA has granted premarket approval of the company’s ThinPrep Genesis processor for cytology processing and specimen transfer for downstream applications.

April 9, 2021—Hologic has signed a definitive agreement to acquire Mobidiag Oy, a privately held Finnish-French developer of molecular diagnostic tests and instrumentation, for about $795 million.

Feb. 26, 2021–Hologic has completed its acquisition of Biotheranostics for about $230 million. Biotheranostics develops and markets Breast Cancer Index and CancerType ID, two highly differentiated molecular diagnostic tests for breast and metastatic cancers­­.

November 2020—Hologic’s Aptima SARS-CoV-2 assay, which initially received FDA emergency use authorization in May, is now authorized for testing people without symptoms or other reasons to suspect COVID-19 infection.

Oct. 7, 2020—Hologic’s Aptima SARS-CoV-2 assay, which initially received emergency use authorization from the FDA in May, is now authorized for testing people without symptoms or other reasons to suspect COVID-19 infection.

June 2020—Hologic announced it has received emergency use authorization from the FDA for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.

May 15, 2020—Hologic announced it has received emergency use authorization from the FDA for its Aptima SARS-CoV-2 assay to detect the novel coronavirus.

April 30, 2020—Hologic plans to launch an Aptima molecular assay to detect the SARS-CoV-2 virus that will run on its Panther system, which provides initial results in about three hours and processes more than 1,000 coronavirus tests in a 24-hour period. The company expects to begin distributing next week a research use only version of its Aptima SARS-CoV-2 test to ...

March 17, 2020—Hologic announced on March 16 that the FDA has granted emergency use authorization for its Panther Fusion SARS-CoV-2 assay. The real-time RT-PCR in vitro diagnostic test is intended for the qualitative detection of RNA from the SARS-CoV-2 isolated and purified from nasopharyngeal and oropharyngeal swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria.

Feb. 26, 2020–Hologic announced that the FDA-approved and CE-marked Panther Plus and Panther Link are available in the U.S. and Europe.

June 12, 2019—Hologic announced FDA clearance for its Aptima BV assay for identifying bacterial vaginosis and its Aptima CV/TV assay for identifying Candida vaginitis and Trichomonas vaginalis.

June 5, 2019—Two diagnostic tests for extragenital testing for chlamydia and gonorrhea have received 510(k) clearance by the U.S. Food and Drug Administration. The Aptima Combo 2 Assay (Hologic) and the Xpert CT/NG (Cepheid) are the first devices cleared for detecting the presence of Chlamydia trachomatisand Neisseria gonorrhoeaevia the throat and rectum. These tests were previously only cleared for testing urine, vaginal, and endocervical samples.  

January 2019—Hologic announced the availability of Open Access functionality for its Panther Fusion system. This enhanced functionality will allow CLIA-certified laboratories to develop laboratory-developed tests to run on the fully automated Fusion platform.

Nov. 13, 2018—Hologic announced the availability of Open Access functionality for its Panther Fusion system. The enhanced functionality will allow CLIA-certified laboratories to develop laboratory-developed tests to run on the fully automated Fusion platform. Laboratories will be able to run their LDTs simultaneously with commercially available IVD assays, and results will release automatically to laboratory information systems. “We know that ...

October 2018—Hologic received FDA clearance for its group B Streptococcus assay on the Panther Fusion system. The Panther Fusion GBS assay is a real-time PCR assay for the qualitative detection of group B strep in antepartum women with dual-target detection of Cfb and SIP genes.

August 2018—Hologic has obtained approval from Health Canada for its Panther Fusion system and Panther Fusion assays for respiratory virus infections. The Panther Fusion module adds the capacity to run PCR assays in addition to tests based on transcription-mediated amplification, the proprietary Hologic chemistry that powers the company’s Aptima brand.

March 2018—Hologic announced that its CE-marked Aptima HIV-1 Quant Dx assay has been awarded World Health Organization prequalification for in vitro diagnostics.

December 2017—Hologic has received FDA 510(k) clearance for its Panther Fusion Paraflu assay, a multiplexed assay that runs on the Panther Fusion system.

July 2014—Hologic’s Tomcat instrument performs a full range of sample processing activities for liquid-based cytology samples, from decapping and capping of sample tubes to vortexing, aliquoting, incubating, and racking of each sample. The fully automated instrument provides positive bar-code matching for each sample as well as reagent addition if desired. By eliminating repetitive manual steps, the instrument enhances workflow efficiency and reduces hands-on time, which minimizes the risk of cross-contamination.

January 2014—The FDA has approved Hologic’s Aptima HPV 16 18/45 genotype assay for use on its fully automated Panther system. The Aptima HPV 16 18/45 genotype assay is performed using Hologic’s ThinPrep liquid cytology specimen and is intended to test specimens from women with Aptima HPV assay-positive results. The addition of HPV genotype 45 is designed to help identify more women at risk for adenocarcinoma, with minimal impact to colposcopy rates.

Quest Diagnostics and Hologic have entered into a strategic alliance to more broadly offer testing based on Hologic’s Aptima family of products, as well as to co-develop and promote advanced diagnostic solutions to improve women’s health.

Hologic has received FDA clearance to market its Aptima Trichomonas vaginalis assay on the company’s automated Panther system.