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Hologic

Hologic

Designs and provides products for clinical laboratory and blood screening, including testing items for detection of human diseases, such as tuberculosis, strep throat, pneumonia, and sexually transmitted diseases, as well as for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) contamination of bloo ...
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Covid-19 Hologic

Clinical Laboratory

COVID-19 Assay
Novodiag COVID-19 Assay

The Novodiag COVID-19 assay, performed with the Novodiag System, is a cartridge-based RT-PCR test for qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The CE marked test uses nasopharyngeal swab samples from patients and delivers clinical confidence in approximately an hour.
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SARS-CoV-2 Test
SARS-CoV-2 Trifecta

The SARS-CoV-2 Trifecta for SARS-CoV-2 testing has superior sensitivity and simplifies workflow as it can be collected and loaded directly on the Panther system without uncapping or specimen transfer. The test allows to deliver more results in less time with a high-throughput fully automated instrument.
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Direct Load Tube Collection Kit
Direct Load Tube Collection Kit

The Direct Load Tube Collection Kit transforms specimen processing for COVID testing by eliminating the need for uncapping and specimen transfer. Labs can expedite their SARS-CoV-2 workflow with the collection device that loads directly on the Panther system.
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Direct Load Capture Cap Collection Kit
Direct Load Capture Cap Collection Kit

The Direct Load Capture Cap Collection Kit transforms specimen processing for COVID testing by eliminating the need for uncapping and specimen transfer. Labs can expedite their SARS-CoV-2 workflow with the collection device that loads directly on the Panther system.
More details

SARS-CoV-2 Assay
Panther Fusion SARS-CoV-2 assay

The Panther Fusion SARS-CoV-2 assay is a real-time PCR in vitro diagnostic test utilizing Hologic's proprietary TMA technology for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, nasal and oropharyngeal swab specimens and lower respiratory tract specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. The assay runs on both Hologic's Panther® and Panther Fusion systems®, enabling labs to run over 10,00 tests in 24 hours and attain first results in 3.5 hours or less.
More details

SARS-CoV-2 Assay
Aptima SARS-CoV-2 assay

The Aptima SARS-CoV-2 assay is an in vitro diagnostic test utilizing Hologic's proprietary TMA technology for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, nasal and oropharyngeal swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. The assay runs on both Hologic's Panther® and Panther Fusion systems®, enabling labs to run over 10,00 tests in 24 hours and attain first results in 3.5 hours or less.
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News of Hologic

Hologic Acquires Bolder Surgical to Expand Surgical Franchise

20 Oct 2021
Hologic Acquires Bolder Surgical to Expand Surgical Franchise
Hologic, Inc. (Marlborough, MA, USA) is set to acquire Bolder Surgical (Louisville, CO, USA; www.boldersurgical.com), a provider of advanced energy vessel sealing surgical devices, in a deal that will expand its surgical franchise.
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Hologic Completes Acquisition of Mobidiag

24 Jun 2021
Hologic Completes Acquisition of Mobidiag
Hologic, Inc. (Marlborough, MA, USA) has completed its previously announced acquisition of Mobidiag Ltd. (Espoo, Finland), an innovator in near-patient, acute care molecular diagnostic testing, for an enterprise value of approximately USD 808 million.
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Hologic Acquires European Molecular Diagnostic Company Diagenode

02 Mar 2021
Hologic Acquires European Molecular Diagnostic Company Diagenode
Hologic, Inc. (Marlborough, MA, USA) has acquired Diagenode (Liège, Belgium), a developer and manufacturer of molecular diagnostic assays and epigenetics products, which is expected to diversify its diagnostic business across test menu, customer segments and geography.
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Hologic Partners with Google Cloud to Focus on AI and Machine Learning for Advancing Digital Diagnostic Capabilities

04 Feb 2021
Hologic Partners with Google Cloud to Focus on AI and Machine Learning for Advancing Digital Diagnostic Capabilities
Hologic, Inc. (Marlborough, MA, USA) and Google Cloud have entered into a new agreement to focus on enhancing artificial intelligence (AI) and machine learning (ML) to bring about breakthrough results in cervical cancer screening.
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Hologic to Acquire Diagnostic Tests Provider Biotheranostics

07 Jan 2021
Hologic to Acquire Diagnostic Tests Provider Biotheranostics
Hologic, Inc. (Marlborough, MA, USA) has agreed to acquire Biotheranostics, Inc. (San Diego, CA, USA), a privately held, commercial-stage company that provides molecular diagnostic tests for breast and metastatic cancers, for approximately USD 230 million.
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Hologic Acquires SOMATEX Medical Technologies

05 Jan 2021
Hologic Acquires SOMATEX Medical Technologies
Hologic, Inc. (Marlborough, MA, USA) has completed the acquisition of SOMATEX Medical Technologies GmbH (Berlin, Germany), a leader in biopsy site markers and localization technologies, for approximately USD 64 million.
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Hologic Receives FDA Clearance for Genius AI Detection Technology for Early Breast Cancer Detection

02 Dec 2020
Hologic Receives FDA Clearance for Genius AI Detection Technology for Early Breast Cancer Detection
Hologic, Inc. (Marlborough, MA, USA) has received US Food and Drug Administration (FDA) clearance for its Genius AI Detection technology, a new deep learning-based software designed to help radiologists detect subtle potential cancers in breast tomosynthesis images.
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Hologic Showcased Latest Advances at Virtual ECR Congress 2020

20 Aug 2020
Hologic Showcased Latest Advances at Virtual ECR Congress 2020
Hologic, Inc. (Marlborough, MA, USA) showcased its latest advances and shared its new innovations on its virtual booth at the online ECR 2020 event held on July 15-21.
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Hologic to Sell Blood-Screening Business to Grifols for USD 1.85 Billion

15 Dec 2016
Hologic to Sell Blood-Screening Business to Grifols for USD 1.85 Billion
US medical device maker Hologic, Inc. has agreed to sell off its share of the Procleix blood-screening business to long-time partner, Grifols SA, for USD 1.85 billion in cash.
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About Hologic

Number of Employees: 1000+
Year of Establishment: 1986
Designs and provides products for clinical laboratory and blood screening, including testing items for detection of human diseases, such as tuberculosis, strep throat, pneumonia, and sexually transmitted diseases, as well as for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) contamination of blood supply

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Laparoscopic Radiofrequency Ablation
Acessa

The Acessa Laparoscopic Radiofrequency Ablation (Lap-RFA) procedure is a minimally invasive, outpatient treatment that involves two small abdominal incisions and uses controlled radiofrequency energy, heat, to cause coagulative necrosis of the fibroid tissue. Unlike many alternative interventions, the Acessa procedure optimizes imaging of the uterus by simultaneously displaying the laparoscopic camera view and the ultrasound view in real-time, so physicians can identify and treat nearly all locations of fibroids, including those outside the uterine cavity and within uterine walls.
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Specimen Radiography System
Trident

The Trident Specimen Radiography System revolutionizes breast tissue imaging by incorporating a micro-focused tube, unique specimen image processing algorithms and amorphous selenium direct digital detector, resulting in sharp, high quality images for rapid specimen verification. It features an intuitive user interface ideal for non-technical operators, with one-touch X-ray automatic exposure control (AEC), a lighted specimen X-ray chamber and large active imaging area. The system incorporates easy-to-use software with a simple, yet robust toolset.
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Automated Sample Processor
ThinPrep 5000 Processor

The ThinPrep 5000 Processor frees up operators so they can focus on other tasks with continuous, hands-free processing of the ThinPrep Pap test, ThinPrep Non-Gyn and ThinPrep UroCyte samples with up to 45 minutes of walkaway time. Up to 20 vials, slides and filters can be loaded at once while a user-friendly touch screen interface offers real-time progress tracking and reporting.
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Medical Imaging

Specimen Radiography System
Trident

The Trident Specimen Radiography System revolutionizes breast tissue imaging by incorporating a micro-focused tube, unique specimen image processing algorithms and amorphous selenium direct digital detector, resulting in sharp, high quality images for rapid specimen verification. It features an intuitive user interface ideal for non-technical operators, with one-touch X-ray automatic exposure control (AEC), a lighted specimen X-ray chamber and large active imaging area. The system incorporates easy-to-use software with a simple, yet robust toolset.
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Ultrasound System
SuperSonic MACH 20

The SuperSonic MACH 20 ultrasound system provides added clinical value for general and specialty ultrasound imaging, including of the breast, liver, muscles, and tendons. It features high B-mode image quality and runs on the same UltraFast imaging technology that powers Hologic’s full line of SuperSonic ultrasound systems, allowing users to perform dynamic tissue stiffness evaluation with ShearWave PLUS elastography.
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Ultrasound System
SuperSonic™ MACH 40

The SuperSonic™ MACH 40 Ultrasound System is designed with image quality excellence in mind, offering smooth images with reduced speckle, regardless of tissue density, and improved lesion conspicuity for enhanced diagnostic confidence. Hologic's first cart-ultrasound system is designed to transform daily experience of breast radiologists and sonographers, offering exceptional versatility across a large variety of clinical applications to further address the needs of general imaging and specialty imaging (abdominal/liver, musculoskeletal, small parts and vascular).
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Breast Stabilization System
SmartCurve

The SmartCurve breast stabilization system provides a curved compression surface that offers a more comfortable patient experience without compromising image quality, exam time, dose or workflow. Clinically proven to deliver a more comfortable mammogram, it improves comfort in 93% of patients who reported moderate to severe discomfort with standard compression.
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Breast Biopsy System
Brevera

The Brevera breast biopsy system streamlines the entire breast biopsy process from start to finish – with real-time imaging for instant verification and automated post-biopsy specimen handling. Its reusable device driver and disposable needles provide new functionality, simplify storage and improve waste management.
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Breast Ultrasound
Viera

The Viera delivers accurate diagnostic images at the POC. It is ideal for quick visual confirmations, interventional procedures, vascular access and imaging small parts, enabling optimization of clinical workflow
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Mammography System
3Dimensions

The 3Dimensions mammography system provides higher quality 3D images for radiologists, enhanced workflow for technologists, and a more comfortable mammography experience, with low-dose options, for patients. Touted as the fastest, highest resolution breast tomosynthesis system ever, it detects up to 65 percent more invasive breast cancers and is the only mammogram approved by the US FDA as superior for women with dense breasts as compared to 2D alone.
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3D Mammography System
Selenia Dimensions

The Selenia Dimensions is a 3D mammography system that uses breast tomosynthesis technology for a rapid four-second scan time and low patient dose due to the elimination of 2D X-ray exposures. It is the world’s first and only tomosynthesis-guided biopsy and delivers exceptionally sharp images and seamless transition between imaging modes.
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3-D Mammography
Genius 3-D

The Genius 3-D Mammography is designed to allow doctors to see masses and distortions associated with cancers more clearly than with traditional 2-D mammography. The Genius detects 41% more invasive breast cancers, while reducing patient callbacks due to false alarms.
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Surgery

Laparoscopic Radiofrequency Ablation
Acessa

The Acessa Laparoscopic Radiofrequency Ablation (Lap-RFA) procedure is a minimally invasive, outpatient treatment that involves two small abdominal incisions and uses controlled radiofrequency energy, heat, to cause coagulative necrosis of the fibroid tissue. Unlike many alternative interventions, the Acessa procedure optimizes imaging of the uterus by simultaneously displaying the laparoscopic camera view and the ultrasound view in real-time, so physicians can identify and treat nearly all locations of fibroids, including those outside the uterine cavity and within uterine walls.
More details

Fluid Management System
Aquilex

The Aquilex fluid management system is designed to optimize high-aspiration procedures such as MyoSure tissue removal and help maintain control. It includes a non-weight-based inflow volume measurement system that reduces the risk of inaccurate deficit readings.
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Fluid Management System
Fluent

The Fluent fluid management system was designed using input from healthcare professionals who have endured the complexities of fluid management firsthand. Its intuitive operation can streamline hysteroscopic procedures for the entire OR team.
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Endometrial Ablation (GEA) Device
NovaSure V5

The new NovaSure V5 global endometrial ablation (GEA) device has an updated cervical seal, featuring EndoForm technology, designed to increase the sealing surface and accommodate a range of cervical canals and anatomical variability. The device’s AccuSheath markings are designed to improve the accuracy and confidence of seating and fundal placement. It is also equipped with SureClear technology, Hologic's unique fluid removal system, which provides integrated suction through the array by constant tissue contact while simultaneously removing ablation by products such as vapor and fluid from the uterus. The NovaSure V5 endometrial ablation system is not only outfitted to support the physician through comfort and control but is also specifically designed to cater to various cervical canal sizes.
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Endometrial Ablation Procedure
NovaSure

The NovaSure endometrial ablation procedure is a simple way to reduce or stop menstrual bleeding for women with abnormal uterine bleeding (AUB) and utilizes unique patented technology to deliver customized ablation to each patient. The device is inserted through the cervix to the uterus and emits precisely measured radio-frequency energy to safely remove the endometrium in a quick, one time, five-minute safe and effective procedure.
More details

Breast Biopsy System
Brevera

The Brevera breast biopsy system streamlines the entire breast biopsy process from start to finish – with real-time imaging for instant verification and automated post-biopsy specimen handling. Its reusable device driver and disposable needles provide new functionality, simplify storage and improve waste management.
More details

Clinical Laboratory

Automated Sample Processor
ThinPrep 5000 Processor

The ThinPrep 5000 Processor frees up operators so they can focus on other tasks with continuous, hands-free processing of the ThinPrep Pap test, ThinPrep Non-Gyn and ThinPrep UroCyte samples with up to 45 minutes of walkaway time. Up to 20 vials, slides and filters can be loaded at once while a user-friendly touch screen interface offers real-time progress tracking and reporting.
More details

Digital Cytology Platform
Genius Digital Diagnostics

Genius Digital Diagnostics is the first CE-marked digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced volumetric imaging technology to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women. The system can rapidly analyze all cells on a ThinPrep Pap test digital image, narrowing tens of thousands of cells down to an AI-generated gallery of the most diagnostically relevant images. This provides healthcare providers with the critical information they need to guide earlier detection and better treatment decisions for the patients they serve.
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COVID-19 Assay
Novodiag COVID-19 Assay

The Novodiag COVID-19 assay, performed with the Novodiag System, is a cartridge-based RT-PCR test for qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The CE marked test uses nasopharyngeal swab samples from patients and delivers clinical confidence in approximately an hour.
More details

Molecular Diagnostics System
Novodiag System

The Novodiag System is a molecular diagnostic platform that offers a simple and fast way to pinpoint patients most at risk with targeted and syndromic on-demand testing. The high multiplex technology is precision engineered for simplicity and accuracy across a broad and growing menu of high and low plex assays to detect common infectious diseases and antibiotic resistance. With just a few simple steps, the Novodiag System delivers rapid results in about an hour, bringing clinical confidence and enabling fast, life-saving diagnoses.
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High Throughput Molecular Testing Solution
Panther Scalable Solutions

Panther Scalable Solutions allow labs to expand their testing menu while adding on flexibility, capacity and walkaway time. The Panther system serves as the foundation of Hologic’s automation with the option to add on the Panther Fusion module, Panther Plus, Panther Link and Panther Trax. Panther Scalable Solutions provide an economical and scalable path to lab’s growth today and into the future. Labs can select from a broad menu of Aptima and Panther Fusion assays to run on scalable automation that can help guide patient care and enable early detection.
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Molecular Cancer Classifier
CancerTYPE ID

CancerTYPE ID is a molecular cancer classifier that helps identify the site of origin for cancers with indeterminate, uncertain, or differential diagnoses. The test uses real-time RT-PCR to measure the expression of 92 genes in the patient’s tumor and classifies the tumor by matching the gene expression pattern of the patient’s tumor to a database of known tumor types and subtypes, encompassing 50 tumor types.
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Molecular Breast Cancer Test
Breast Cancer Index

Breast Cancer Index is a molecular, gene expression-based test used for determining which patients with early-stage, hormone receptor (HR)–positive breast cancer benefit from extended endocrine therapy. It is uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early stage, HR+ breast cancer. This breakthrough test helps oncologists and patients navigate the difficult trade-off between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment.
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Human Cytomegalovirus (CMV) Assay
Aptima CMV Quant Assay

The Aptima CMV Quant Assay is the first in a series of quantitative assays from the Hologic Transplant portfolio to support immunocompromised patient management following transplant surgery. It provides accurate, highly reproducible viral quantitation that provides confidence in ensuring excellence in the clinical management of patients. This proven performance, combined with the benefits of Panther system automation, promotes flexibility and operational efficiency for viral load testing success in molecular labs across the world.
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Methicillin-Resistant Staphylococcus Aureus (MRSA) Assay
Panther Fusion MRSA Assay

The Panther Fusion MRSA Assay is designed for the qualitative detection and differentiation of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. It is intended to aid in the prevention and control of SA and MRSA infections in healthcare settings. The Panther Fusion MRSA assay allows for direct loading of ESwab nasal samples on the Panther Fusion system. It has broad strain inclusivity, including the Bengal Bay clone. It also correctly identifies empty cassette variants.
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Streptococcus Agalactiae (GBS) Assay
Panther Fusion GBS Assay

The Panther Fusion GBS Assay detects the gram-positive bacterium Streptococcus agalactiae (GBS) in pregnant women so providers can help prevent its transmission to their babies. Run on the Panther Fusion system, this assay offers the benefits of Panther Fusion full automation, high-throughput flexibility and ease of use, allowing for high-volume GBS testing in reference laboratories and hospitals.
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Respiratory Assays
Panther Fusion Respiratory Assays

The Panther Fusion Respiratory Assays are the premier set of assays that provide truly personalized syndromic respiratory testing with qualitative detection and differentiation of the most common respiratory viruses. With the Panther Fusion Respiratory assays, a single patient specimen can be tested for SARS-CoV-2 as well as other common respiratory viruses which present with overlapping symptoms, boosting efficiency and increasing clinical insight. These assays can be run on the fully automated Panther Fusion system using nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.
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Direct Load Capture Cap Collection Kit
Direct Load Capture Cap Collection Kit

The Direct Load Capture Cap Collection Kit transforms specimen processing for COVID testing by eliminating the need for uncapping and specimen transfer. Labs can expedite their SARS-CoV-2 workflow with the collection device that loads directly on the Panther system.
More details

Direct Load Tube Collection Kit
Direct Load Tube Collection Kit

The Direct Load Tube Collection Kit transforms specimen processing for COVID testing by eliminating the need for uncapping and specimen transfer. Labs can expedite their SARS-CoV-2 workflow with the collection device that loads directly on the Panther system.
More details

SARS-CoV-2 Test
SARS-CoV-2 Trifecta

The SARS-CoV-2 Trifecta for SARS-CoV-2 testing has superior sensitivity and simplifies workflow as it can be collected and loaded directly on the Panther system without uncapping or specimen transfer. The test allows to deliver more results in less time with a high-throughput fully automated instrument.
More details

SARS-CoV-2 Assay
Aptima SARS-CoV-2 assay

The Aptima SARS-CoV-2 assay is an in vitro diagnostic test utilizing Hologic's proprietary TMA technology for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, nasal and oropharyngeal swab specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. The assay runs on both Hologic's Panther® and Panther Fusion systems®, enabling labs to run over 10,00 tests in 24 hours and attain first results in 3.5 hours or less.
More details

SARS-CoV-2 Assay
Panther Fusion SARS-CoV-2 assay

The Panther Fusion SARS-CoV-2 assay is a real-time PCR in vitro diagnostic test utilizing Hologic's proprietary TMA technology for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, nasal and oropharyngeal swab specimens and lower respiratory tract specimens obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria. The assay runs on both Hologic's Panther® and Panther Fusion systems®, enabling labs to run over 10,00 tests in 24 hours and attain first results in 3.5 hours or less.
More details

Molecular Testing Instrument
Panther Fusion

The Panther Fusion system is a powerful molecular testing instrument that combines PCR and TMA capabilities on a single platform, allowing for multiple chemistries and even more flexibility on a consolidated system. The full, random-access system gives access to 32 different assays simultaneously and allows for batch-free processing with up to 120 patient samples loaded in any combination at one time.
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Pap+HPV Test
Aptima+ThinPrep Cervical Health

The Aptima+ThinPrep Cervical Health test helps healthcare providers detect the presence of abnormal cervical cells, and the Aptima HPV assays identify high-risk HPV mRNA that is indicative of the HPV infections most likely to lead to cervical disease. Screening with Pap+HPV together (co-testing) provides the best possible protection against cervical cancer for women ages 30-65 and helps them live healthier without enduring a disease that is largely preventable with accurate screening.
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Vaginitis Test
Aptima Vaginal Health

The Aptima Vaginal Health molecular nucleic acid amplification tests (NAAT) aid in the detection of vaginosis and vaginitis and detect the three most common causes of infectious vaginitis: bacterial vaginosis, candida vaginitis and trichomoniasis. Accurate diagnosis using the Aptima vaginal panel supports better guided drug treatment, fewer recurrent doctor office visits, and reduced suffering in affected women.
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STI Tests
Aptima STIs

The Aptima STIs nucleic acid amplification tests (NAATs) for sexually transmitted infections allows lab personnel to deliver results to healthcare providers with confidence, empowering informed choices when it comes to patient care. The Aptima STI testing portfolio offers a diverse STI testing menu and targets common STIs such as chlamydia, gonorrhea, Mycoplasma genitalium, trichomoniasis, herpes and emerging pathogens like the Zika virus.
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Lab Software
Panther Fusion Open Access

The Panther Fusion Open Access is an easy-to-use software for the Panther Fusion system allows labs to design, create and edit unique protocols using the myAccess software. It puts lab technicians in control of their workflow and opens up many new possibilities, including the ability to modify, delete, or even completely change any part of the procedures during optimization.
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Respiratory Assays
Panther Fusion Assays

The Panther Fusion assays for use on the Panther Fusion system provide the flexibility to run patient-specific targets, allowing for personalized patient testing and better cost control in labs. They include respiratory assays for syndromic respiratory testing and GBS assay that detects the gram-positive bacterium Streptococcus agalactiae (GBS) in pregnant women.
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Virology Assays
Aptima Virology

The Aptima Virology assays for HIV-1, HCV and HBV deliver reliable quantitation to aid in the clinical management of these challenging viruses and may be run in conjunction with the Aptima STI (sexually transmitted infections) portfolio and Aptima HPV assays. Designed to run on the fully automated Panther system, they use Hologic’s proprietary real-time transcription mediated amplification (TMA) technology to deliver strong assay performance, industry-leading sensitivity, broad dynamic range and flexibility in sample requirements.
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Clinical Diagnostics System
Panther

The Panther system features random access and continuous loading of molecular samples, reagents and consumables. The system offers walk-away freedom and is designed to improve lab productivity, accelerate results and help enhance patient care, all while reducing lab costs.
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