About Hologic

Hologic, Inc. operates as a developer, manufacturer and supplier of premium diagnostics products, medical imaging systems, and surgical products focused on women's health and well-being through early detection and treatment. The company sells and services its products through a combination of direct sales and service personnel and a network of independent distributors and sales representatives. Segments The company operates through four segments: Diagnostics, Breast Health, GYN Surgical, and Skeletal Health. Diagnostics This segment offers a wide range of diagnostic products, which are used primarily to aid in the screening and diagnosis of human diseases. The company's primary Diagnostics products include its molecular diagnostic assays, which run on its advanced instrumentation systems (Panther, Panther Fusion and Tigris), its ThinPrep cytology system, and the Rapid Fetal Fibronectin Test. The company's Aptima family of molecular diagnostic assays is used to detect, among other things, the infectious microorganisms that cause common sexually transmitted diseases, or STDs, such as chlamydia and gonorrhea, or CT/NG; certain high-risk strains of human papillomavirus, or HPV; Trichomonas vaginalis, the parasite that causes trichomoniasis; Mycoplasma genitalium; and Herpes Simplex viruses 1 and 2. The company also offers viral load tests for the quantitation of Hepatitis B virus, Hepatitis C virus, human immunodeficiency virus, or HIV-1, and human cytomegalo virus, or CMV, for use on its Panther instrument system. In addition, the company offers bacterial vaginosis and candida vaginitis assays for the diagnosis of vaginitis, a common and complex ailment affecting millions of women a year. The company's assay portfolio also includes diagnostic tests for a range of acute respiratory infections, including SARS-CoV-2, various strains of influenza and parainfluenza, and respiratory syncytial virus, as well as a test for the detection of Group B Streptococcus, or GBS, that are run on the Panther Fusion system, a field upgradeable instrument addition to the base Panther system. In response to the COVID-19 pandemic, the company developed and launched the Aptima SARS-CoV-2 assay and the Aptima SARS-CoV-2/Flu assay (each of which runs on its standard Panther system) and the Panther Fusion SARS-CoV-2 assay (which runs on its Panther Fusion system). In May 2022, the company CE-marked two new molecular assays, Panther Fusion EBV Quant assay for quantitation of Epstein-Barr virus, and the Panther Fusion BKV Quant assay for quantitation of the BK virus. These two new assays are the first quantitative real-time PCR assays on the Panther Fusion system. These assays, along with the Aptima CMV Quant assay already available in Europe, expand the company's menu of transplant monitoring assays. The ThinPrep System is primarily used in cytology applications, such as cervical cancer screening, and the Rapid Fetal Fibronectin Test assists physicians in assessing the risk of pre-term birth. The company also generates service revenues from its Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory for testing related to breast cancer and all metastatic cancers. Breast Health This segment offers a broad portfolio of solutions for breast cancer care primarily in the areas of radiology, breast surgery, pathology and treatment. These solutions include 3D digital mammography systems, image analytics software utilizing artificial intelligence, reading workstations, minimally invasive breast biopsy guidance systems, breast biopsy site markers, localization, specimen radiology, connectivity solutions and breast conserving surgery products. The company's most advanced breast imaging platforms, Selenia 3D Dimensions and 3Dimensions systems, utilize tomosynthesis to produce 3D images that show multiple contiguous slice images of the breast, which it refers to as the Genius 3D Mammography exam. GYN Surgical This segment's products include the company's MyoSure hysteroscopic tissue removal system, or MyoSure, its NovaSure endometrial ablation system, or NovaSure, its Fluent fluid management system, or Fluent, its Acessa ProVu laparoscopic radiofrequency ablation system, or Acessa ProVu, as well as its CoolSeal vessel sealing portfolio and its JustRight surgical stapler. The MyoSure suite of devices offers four options to provide incision-less removal of fibroids, polyps, and other pathology within the uterus. The NovaSure portfolio consist of the NovaSure CLASSIC device, NovaSure ADVANCED device and the NovaSure V5 device for the treatment of abnormal uterine bleeding. The Fluent system is a fluid management system that provides liquid distention during diagnostic and operative hysteroscopic procedures. The Acessa ProVu system is a fully integrated system that uses laparoscopic ultrasound, guidance mapping and radiofrequency ablation to treat nearly all types of fibroids. The CoolSeal portfolio includes the Trinity, Reveal, and Mini advanced bipolar vessel sealing devices. The JustRight 5 mm stapler features a smaller instrument profile and is used for laparoscopic general and pediatric surgery. Skeletal Health This segment's products include the Horizon DXA, a dual energy x-ray system, which evaluates bone density and performs body composition assessments, and the Fluoroscan Insight FD mini C-arm, which assists in performing minimally invasive orthopedic surgical procedures on a patient's extremities, such as the hand, wrist, knee, foot, and ankle. Products Diagnostics Product Offerings Molecular Diagnostic Instrumentation The company has developed and continues to develop instrumentation and software designed specifically for use with certain of its molecular diagnostic assays. It also provides technical support and service to maintain these instrument systems in the field. By placing its proprietary instrumentation in laboratories and hospitals, the company can establish a platform for future sales of its assays. The company's instrumentation includes the Tigris system, an integrated, fully automated testing instrument for high-volume laboratories which is approved for use with certain of its Aptima assays; and the Panther instrument system, an integrated, fully automated testing instrument capable of serving high-, medium- and low-volume laboratories. The company's Panther Fusion system, including the related Fusion assays for flu, respiratory and transplant testing, extends the capabilities of its Panther system by adding the flexibility of polymerase chain reaction, or PCR, functionality to its existing Transcription Mediated Amplification, or TMA, based technology. The Panther Fusion system is available as a modular in-lab upgrade to the company's base Panther system. In addition, the company's instrumentation includes the Tomcat instrument, a fully automated general-purpose instrument designed to improve pre-analytical sample processing by eliminating the inefficient and error-prone activities associated with manually transferring samples from one tube to another. Molecular Diagnostic Assay Portfolio The company has a broad menu of assays available for sale in its primary markets that can be performed on the base Panther System or on the combined Panther Fusion System. The company's Aptima family of molecular diagnostic assays integrate a number of proprietary core technologies, including its target capture technology, its TMA technology, and its hybridization protection assay, or HPA, and dual kinetic assay, or DKA, technologies, to produce highly sensitive amplification assays. The company's Panther Fusion family of molecular diagnostic assays are performed on the Panther Fusion System and utilize PCR (polymerase chain reaction) technology to amplify target nucleic acid sequences for easier detection. Aptima-branded assays that are performed on the base Panther System include Aptima HPV assay; Aptima HPV 16 18/45 Genotype assay; Aptima HBV Quant assay; Aptima CMV Quant assay; Aptima HIV-1 Quant Dx assay; Aptima HCV Quant Dx assay; Aptima Mycoplasma genitalium assay; Aptima Combo 2 assay (CT/NG); Aptima Trichomonas vaginalis assay; Aptima HSV 1 and 2 assay; Aptima CV/TV assay; Aptima BV assay; Aptima Zika assay; Aptima SARS-CoV-2 assay; and Aptima SARS-CoV-2/Flu assay. Panther Fusion-branded assays that are performed on the Panther Fusion System include Panther Fusion Flu A/B/RSV assay; Panther Fusion Paraflu assay; Panther Fusion AdV/hMPV/RV assay; Panther Fusion SARS-CoV-2/Flu A/B/RSV assay; Panther Fusion GBS assay; Panther Fusion MRSA assay; Panther Fusion Bordetella assay; Panther Fusion EBV Quant assay; Panther Fusion BKV Quant assay; and Panther Fusion SARS-CoV-2 assay. Proprietary Core Technologies Target Capture/Nucleic Acid Extraction Technology: The detection of target organisms that are in small numbers in a large-volume clinical sample requires that target organisms be concentrated to a detectable level. One way to accomplish this is to isolate the particular nucleic acid of interest by binding it to a solid support. This support, with the target bound to it, can then be separated from the original sample. The company refers to such techniques as 'target capture'. The company has developed target capture techniques to immobilize nucleic acids on magnetic beads by using a 'capture probe' that binds to the bead and to the target nucleic acid. The company uses magnetic separation to concentrate the target by drawing the magnetic beads to the sides of a sample tube, while the remainder of the sample is removed from the tube. When used in conjunction with the company's amplification procedures, target capture techniques concentrate the nucleic acid target(s) and also remove materials in the sample that might otherwise interfere with amplification. Transcription-Mediated Amplification (TMA) Technology: The goal of amplification technologies is to increase the copy number of a target nucleic acid sequences that may be present in samples in small numbers. These copies can then be detected using nucleic acid probes. Amplification technologies can yield results in only a few hours versus the several days or weeks required for traditional culture methods. TMA is a transcription-based amplification system that uses two different enzymes to drive the process. The first enzyme is a reverse transcriptase that creates a double-stranded DNA copy from an RNA or DNA template. The second enzyme, an RNA polymerase, makes thousands of copies of the complementary RNA sequence, known as the 'RNA amplicon', from the double-stranded DNA template. Each RNA amplicon serves as a new target for the reverse transcriptase and the process repeats automatically, resulting in an exponential amplification of the original target that can produce over a billion copies of the RNA amplicon in less than thirty minutes. Hybridization Protection Assay (HPA) and Dual Kinetic Assay (DKA) Technologies: With its HPA technology, the company has simplified testing, further increased test sensitivity and specificity, and increased convenience. In the HPA process, the acridinium ester, or AE, molecule is protected within the double-stranded helix that is formed when the probe binds to its specific target. Prior to activating the AE molecule, known as 'lighting off', a chemical is added that destroys the AE molecule on any unhybridized probes, leaving the label on the hybridized probes largely unaffected. When the 'lighting off' or detection reagent is added to the specimen, only the label attached to the hybridized probe is left to produce a signal indicating that the target organism's DNA or RNA is present. All of these steps occur in a single tube and without any wash steps, which were required as part of conventional probe tests. The company's DKA technology uses two types of AE molecules that can be differentiated from each other - one that 'flashes' and another one that 'glows'. By using DKA technology, the company has created nucleic acid test, or NAT, assays that can detect two separate targets simultaneously. ThinPrep System The ThinPrep System is the most widely used method for cervical cancer screening in the U.S. The ThinPrep System has multiple configurations, including one or more of the following: the ThinPrep 2000 Processor, ThinPrep 5000 Processor, ThinPrep 5000 Processor with Autoloader, ThinPrep Genesis Processor, ThinPrep Imaging System, ThinPrep Integrated Imager, and related reagents, filters and other supplies, such as the ThinPrep Pap Test and the company's ThinPrep PreservCyt Solution. The ThinPrep Process: The ThinPrep process begins with the patient's cervical sample being obtained by the physician using a cervical sampling device that, rather than being smeared on a microscope slide as in a conventional Pap smear, is inserted into a vial filled with the company's proprietary ThinPrep PreservCyt Solution. This enables most of the patient's cell samples to be preserved before the cells can be damaged by air drying. The ThinPrep specimen vial is then labeled and sent to a laboratory equipped with a ThinPrep Processor for slide preparation. At the laboratory, the ThinPrep specimen vial is inserted into a ThinPrep Processor, a proprietary sample preparation device, which automates the process of preparing cervical slides for staining and microscopic examination. Additionally, an aliquot used for subsequent molecular testing can be produced using the ThinPrep Genesis Processor. In the case of manual screening, the cytotechnologist screens each Pap test slide with a microscope to first determine the adequacy of the slide and then to examine the entire slide to differentiate diseased or abnormal cells from normal cells. With the ThinPrep Imaging Systems, the screening process has been automated to combine the power of computer imaging technology with human interpretive skills. Prior to human review, the ThinPrep Imaging Systems rapidly scan, locate and highlight areas of interest for review. By directing the cytotechnologist to areas of interest on a slide, these systems may increase a cytology laboratory's screening productivity and diagnostic accuracy. Additional Applications: In addition to serving as a replacement for the conventional Pap smear, the ThinPrep System can be used for non-gynecological cytology screening applications, including fine-needle aspiration specimens (e.g., breast, thyroid, lung or liver), body fluids (e.g., urine, pleural fluid, ascitic fluid or pericardial fluid), respiratory specimens (e.g., sputum or brushing of respiratory tracts) and ancillary testing (e.g., cell blocks, immunocytochemistry or special stains). Genius Digital Diagnostics The Genius Digital Diagnostics System is the first CE-marked digital cytology platform to combine a new artificial intelligence, or AI, algorithm with advanced volumetric imaging technology to help cytotechnologists and pathologists identify pre-cancerous lesions and cervical cancer cells in women. The Genius Digital Diagnostics System consists of an advanced digital imager featuring volumetric imaging technology, a secure image management server to store images, a deep learning-based AI algorithm that is designed to assist healthcare providers in detecting pre-cancerous lesions and cervical cancer cells, and a high-resolution review station for local or remote case review. The Genius Digital Diagnostics 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 images that have been selected as the most diagnostically relevant images, which gives healthcare providers additional critical information to help guide earlier detection and make better treatment decisions for patients. The Genius Digital Diagnostics System was CE-marked for diagnostic use in November 2020, and the company has submitted a De Novo request to the FDA to grant class II marketing authorization for the product in the U.S. Rapid Fetal Fibronectin Test The Rapid Fetal Fibronectin Test is a single-use disposable test used to determine a woman's risk of pre-term birth by detecting the presence of a specific protein, fetal fibronectin, in vaginal secretions during pregnancy. The test utilizes a single-use, disposable cassette and is analyzed on the company's instrument, the TLi IQ System. Oncology Product Offerings The company's Biotheranostics business offers two proprietary laboratory developed tests, or LDTs, that support physicians in the treatment of cancer: the Breast Cancer Index test and the CancerTYPE ID test. The Breast Cancer Index, or BCI, test is a PCR-based gene expression test used for determining which patients with early-stage, hormone-receptor positive, or HR+, breast cancer are likely to benefit from extended endocrine therapy. In January 2021, the National Comprehensive Cancer Network revised its clinical practice guidelines to include BCI as the only gene expression assay to predict benefit from extended endocrine therapy for patients with early-stage HR+ breast cancer. In addition, in April 2022 the American Society of Clinical Oncology updated its clinical practice guidelines, which include BCI as the only genomic test to help guide extended endocrine therapy decisions in early-stage, HR+ breast cancer patients. The CancerTYPE ID test is a PCR-based gene expression test that is designed to identify the source of metastatic cancer in order to improve diagnostic accuracy and inform treatment decisions. Both of these LDTs are offered as a service solely out of Biotheranostics' licensed, CLIA-certified, CAP-accredited laboratory in San Diego, California. Mobidiag Product Offerings The company's Mobidiag business develops and markets PCR-based tests for acute care conditions, such as gastrointestinal and respiratory infections (including SARS-CoV-2), antimicrobial resistance management, and healthcare associated infections. The Amplidiag and Novodiag platforms are automated instruments that deliver rapid turnaround times ranging from 50 minutes to two hours. The Novodiag instrument combines real-time PCR and microarray capabilities to provide high level multiplexing, assisting clinicians in efficiently identifying which organism is responsible for an infection. Although Mobidiag does not offer any of its products in the U.S., the company intends to invest in assay development to drive growth of the Novodiag instrument, including seeking clearance for the Novodiag instrument and related assays in the U.S. Breast Health Products Mammography Solutions The company's Dimensions platform includes the Selenia Dimensions and 3Dimensions systems capable of performing full field digital mammography (2D) and digital breast tomosynthesis (3D) exams. When performing a 3D exam, each system acquires a series of low dose x-ray images taken in a scanning motion at various angles. The images are mathematically reconstructed into a series of small contiguous slices, allowing for visualization of the breast tissue through multiple layers. The company's clinical results for FDA approval demonstrate that conventional 2D digital mammography with the addition of its Genius 3D Mammography is superior to 2D digital mammography alone for both screening and diagnostics. Hologic Clarity HD technology provides its highest resolution imaging, and its C-View and Intelligent 2D software products generate 2D images that are mathematically synthesized from the tomosynthesis data. These software products are FDA approved to replace conventional 2D images within a 3D exam. Synthesized 2D images eliminate the need for additional 2D exposure, reducing breast compression time and patient dose compared to a 'combo' exam, which includes a tomosynthesis exam and a conventional digital 2D exam. The company's 3DQuorum technology is an artificial intelligence, or AI, powered algorithm that expedites mammography exam reading time without compromising image quality, sensitivity or accuracy. The 3DQuorum technology uniquely reconstructs Hologic Clarity HD 3D data to produce 6 mm 'SmartSlices'. By utilizing 3DQuorum technology the number of 3D images to review is reduced by two-thirds, saving an estimated average of one hour per eight hours of daily image interpretation time. The 3DQuorum technology also reduces the typical Hologic Clarity HD and Intelligent 2D study size by approximately 50%, bringing the storage space and network impact back down to that of standard resolution 3D imaging. The images captured by digital mammography systems are typically transmitted electronically for review by a radiologist at a reading workstation. To address this process, the company offers the SecurViewDX workstation approved for interpretation of mammograms, as well as images from other diagnostic breast modalities, including breast ultrasound and breast MRI. The company also offers image analytic products, such as the Genius AI Detection solution (Hologic's first artificial intelligence cancer detection algorithm utilizing deep-learning technology for tomosynthesis), ImageChecker CAD-solution (provides markings of suspicious areas of the breast that may be cancerous), and Quantra software (automates breast density measurement for its mammography systems). These technologies provide reviewers with the potential to focus on key patients that might otherwise be overlooked during the review process for additional diagnostic workups, thus potentially increasing cancer detection. Stereotactic Breast Biopsy Systems The company provides clinicians flexibility by offering two minimally invasive stereotactic breast biopsy guidance systems: the Affirm prone and the Affirm upright breast biopsy guidance systems. The Affirm upright biopsy system is an attachment designed to integrate with the company's Dimensions systems, transforming it into a versatile tool for both screening and tomosynthesis biopsy. The Affirm prone biopsy system is a dedicated prone stereotactic biopsy system capable of both 2D and tomosynthesis-guided procedures. These systems provide an alternative to open surgical biopsy and can be performed as an outpatient procedure under local anesthesia, allowing shorter recovery times. The Affirm tomosynthesis option provides faster lesion targeting and reduced patient procedure time compared to traditional stereotactic biopsy procedures. The Affirm system is pre-programmed for use with the company's Brevera, Eviva and ATEC vacuum-assisted breast biopsy devices. Breast Biopsy and Surgery Products The company offers a wide range of minimally invasive products for breast biopsy and breast surgery. Its breast biopsy portfolio includes three types of tethered vacuum-assisted breast biopsy products: the Brevera, ATEC, and Eviva devices. Each tethered device is powered by a console and utilizes the company's fluid management system. The ATEC device can be used under all standard imaging guidance modalities (stereotactic x-ray, ultrasound, MRI and molecular breast imaging) whereas the company's Brevera and Eviva devices are used exclusively under stereotactic x-ray guidance. The company also offers the Celero and Sertera biopsy devices, both of which are non-tethered (no separate console), spring-loaded, disposable core biopsy devices, which are used exclusively under ultrasound-guidance. The company has products for marking, localizing and filling the void after surgery in addition to specimen imaging products for radiology, surgery and pathology. GYN Surgical Products MyoSure The MyoSure system is designed to provide efficient and effective hysteroscopic removal of tissue within the uterus, including fibroids and polyps. Removal of fibroids can provide effective relief from heavy menstrual bleeding commonly attributed to such pathology. Unlike other methods of tissue removal, the excavated tissue samples remain intact, which allows them to be tested for abnormalities. The MyoSure system consists of a tissue removal device, control unit, and hysteroscope. The MyoSure tissue removal device is single-use and features simultaneous tissue cutting and removal. The device incorporates a rapidly rotating and reciprocating cutting blade. During the procedure, the tissue removal device is inserted through the MyoSure hysteroscope. This tissue removal device is powered by a control unit, which features a simple user interface and is foot pedal activated. The company offers multiple handpiece devices that differ in size and are focused on addressing different pathology types. NovaSure The NovaSure CLASSIC endometrial ablation system allows physicians to treat women suffering from abnormal uterine bleeding. The system features Smart-Depth technology that continuously monitors and measures tissue impedance to provide a more customized, reliable and reproducible depth of ablation for every patient. The NovaSure system consists of a disposable device and a controller that delivers Radio Frequency (RF) energy to ablate the endometrial lining of the uterus in order to eliminate or reduce the patient's abnormal bleeding. The NovaSure disposable device is a hand-held, single-use device that incorporates a flexible gold-plated mesh electrode used to deliver the RF energy to the endometrial tissue. The NovaSure RF Controller generates and delivers RF energy customized for each patient, monitors several critical treatment and safety parameters, and automatically controls the endpoint of the procedure. The company also offers the NovaSure ADVANCED and NovaSure V5 devices, which have a slimmer diameter. These devices are designed to improve patient comfort and physician ease-of-use while maintaining the clinical efficacy of the NovaSure system. Fluent Fluid Management System The company's Fluent Fluid Management System can be utilized for diagnostic and operative hysteroscopic procedures, including MyoSure tissue removal. Fluent features an intuitive touch screen design, innovative FloPak design, and a single waste bag design that eliminates the need for multiple canisters. Therefore, Fluent is designed for simplified setup and operation, and streamlined workflow for the operating room team. Acessa ProVu System The Acessa ProVu system is used by laparoscopic surgeons to treat fibroids using controlled radiofrequency energy (heat) to cause coagulative necrosis. The treated tissue softens and shrinks over time, allowing fibroid symptoms to resolve without more invasive treatment. The Acessa system includes an ultrasound probe to locate the fibroids, guidance mapping that provides visual cues, and a percutaneous handpiece that deploys radiofrequency energy. Advanced Energy and Surgical Stapling The CoolSeal vessel sealing suite and JustRight surgical stapler bolster the company's laparoscopic surgical offerings with the advanced vessel sealing, dividing, dissection, and stapling tools. The CoolSeal device allows for dissection, vessel sealing and dividing all in one tool. The ability to use a combination device improves surgical efficiency by reducing the need for instrument exchanges. In addition, the CoolSeal Mini 3 mm sealer and the JustRight 5 mm stapler are designed for small surgical spaces, such as in pediatric cases, which can help reduce the need for larger, overpowered instruments. Skeletal Health Products Horizon DXA Systems Bone densitometry is the measurement of bone density to assist in the diagnosis and monitoring of osteoporosis and other metabolic bone diseases that can lead to frailty and debilitating bone fractures. Osteoporosis is a disease that is most prevalent in post-menopausal women. The company's Horizon line of x-ray bone densitometers incorporates advanced features designed for bone health screening and body composition assessment. Body composition assessment is the precise measurement of bone, lean mass, and fat mass within the body. These measurements are valued within the health and wellness and human performance categories, informing nutrition and exercise programming decisions. Fluoroscan Insight FD The company's Fluoroscan Insight FD is a mini C-arm imaging system that provides low intensity, real-time x-ray imaging, with high-resolution images at radiation levels and at a cost below those of conventional x-ray and standard sized fluoroscopic equipment. Mini C-arm systems are used primarily by orthopedic surgeons to assist in performing minimally invasive surgical procedures on a patient's extremities, such as the hand, wrist, knee, foot and ankle. Marketing, Sales and Service The company sells and services its products through a combination of direct sales and service forces and a network of independent distributors and sales representatives. The company's U.S. sales force is structured to specifically target the customers in each of its business segments. The company maintains distinct teams focused on the Diagnostics, Breast Health, GYN Surgical, and Skeletal Health markets. The company's end customers include clinical laboratories, hospitals, healthcare providers and surgeons in both hospital and office settings, and it targets various specialists at healthcare entities who use its products, such as ob-gyns, radiologists and breast surgeons. The company's U.S. sales efforts also include the use of national account managers focused on obtaining purchasing contracts from large purchasing entities, such as managed care organizations, integrated delivery networks and government healthcare facilities. In addition, in certain regions of the U.S., the company uses a limited number of independent dealers or distributors to sell and service certain of its products. Internationally, the company's products in all divisions are marketed and sold through a combination of its direct sales force and a network of distributors. The company's Breast Health business generates a majority of its service revenue from service contracts for its digital mammography portfolio. Internationally, the company primarily uses distributors, sales representatives and third parties to provide maintenance service for its products, however the company does provide direct service in countries where it has a subsidiary (Germany, the U.K., France, Spain, Japan, China, and Australia). Competition Diagnostics: The company's ThinPrep liquid-based cytology product faces direct competition in the U.S. primarily from Becton, Dickinson and Company, or BD, which manufactures a competitive offering. Internationally, the company's Rapid Fetal Fibronectin Test competes with Actim Partus manufactured by Medix Biochemica and PartoSure manufactured by Qiagen GmbH, or Qiagen. In the global clinical diagnostics market, the company competes with several companies offering alternative technologies to its diagnostic products. For example, in the U.S., the company's Aptima Combo 2 test competes against Abbott Laboratories, BD, Danaher Corporation (through its acquisition of Cepheid), and Roche Diagnostics Corporation, or Roche, and its Aptima HPV test competes with tests marketed by BD, Qiagen and Roche. Breast Health: The company's mammography and related products and subsystems compete on a worldwide basis with products offered by a number of competitors, including General Electric Company, or GE; Siemens AG, or Siemens; Koninklijke Philips NV, or Philips; Planmed Oy, or Planmed; Carestream Health, Inc., or Carestream; FUJIFILM Holdings Corporation, or Fuji; Internazionale Medico Scientifica Srl, or I.M.S.; and Toshiba Corporation. In the U.S., the company's digital mammography systems compete with digital mammography systems from GE, Siemens, Fuji, and Philips. The company's digital mammography systems also compete with Fuji's and Carestream's Computed Radiography, or CR mammography systems, and other lower-priced alternatives to 2D digital mammography and analog mammography systems. The company's Dimensions tomosynthesis systems also compete in certain countries outside of the U.S. with tomosynthesis systems developed by GE, Siemens, Fuji, and I.M.S. The primary competitor for the company's breast biopsy product line is Devicor Medical Products, Inc., part of Danaher Corporation's Leica Biosystems division. In addition, other competitors include CareFusion, a BD company and Intact Medical Corporation. GYN Surgical: The company's MyoSure product competes directly with hysteroscopic loop resection, as well as hysteroscopic tissue removal systems, such as Medtronic plc's TruClear device and Minerva's Symphion device. The company's NovaSure system faces direct competition from The Cooper Companies, Inc (CooperSurgical) and Minerva Surgical, Inc. (Minerva), each of which markets an FDA-approved endometrial ablation device for the treatment of abnormal uterine bleeding. The company's Acessa ProVu system competes directly with Gynesonics, Inc., which markets a radiofrequency ablation device for treating uterine fibroids. The company's CoolSeal vessel sealing suite competes directly with Applied Medical's Voyant vessel sealing, Medtronic's LigaSure vessel sealing, Ethicon's ENSEAL vessel sealing and Olympus' THUNDERBEAT and POWERSEAL vessel sealing devices. CoolSeal also competes with ultrasonic energy sealing procedures done by Medtronic's Sonicision and Ethicon's HARMONIC sealing devices. Skeletal Health: GE is the company's primary competitor in the bone densitometry market, and it also competes with Orthoscan Inc. in the mini C-arm market. Manufacturing F. Hoffmann-LaRoche Ltd, a direct competitor of the company's Diagnostics business, is the parent company of Roche, the company's supplier of certain key raw materials for certain of its amplified NAT diagnostic assays. GE Healthcare Bio-Sciences Corp., an affiliate of GE, supplies the company with the membranes used in connection with its ThinPrep product line. GE is a direct competitor with the company's Breast Health and Skeletal Health businesses. Moreover, the company uses certain components in its products, including semiconductor chips, that have been the subject of global supply chain shortages and disruptions. The company has sole source third-party contract manufacturers for each of its molecular diagnostics instrument product lines and for its Skeletal Health products. Stratec SE, or Stratec, is the only manufacturer of the Panther and Panther Fusion instruments; and Flextronics Medical Sales and Marketing, LTD, or Flextronics, is the only manufacturer of its Skeletal Health finished goods products. Regulatory Some of the company's products are also subject to the Radiation Control for Health and Safety Act, administered by the Food and Drug Administration (FDA), which imposes performance standards and record keeping, reporting, product testing and product labeling requirements for devices that emit radiation, such as x-rays. The company's Biotheranostics laboratory in San Diego, California and the laboratories that purchase certain of its products, including the Aptima SARS-CoV-2 EUA (Emergency Use Authorization), Aptima Flu Multiplex EUA, Fusion SARS-CoV-2 EUA, ThinPrep System, ThinPrep Imaging System, Rapid Fetal Fibronectin Test, Aptima Combo 2, Aptima HPV tests and Aptima HIV-1 Quant, HCV Quant Dx, HBV Quant, Aptima Trichomonas Vaginalis (Trich), Aptima Mycoplasma Genitalium (MGen), Aptima HSV 1 & 2, Aptima BV, Aptima CV/TV, and Panther Fusion Assays are subject to extensive regulation under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, which requires laboratories to meet specified standards in the areas of personnel qualifications, administration, participation in proficiency testing, patient test management, quality control, quality assurance and inspections. The company is also subject to a variety of federal, state and foreign laws which broadly relate to its interactions with healthcare practitioners and other participants in the healthcare system, including anti-kickback and anti-bribery laws, such as the Foreign Corrupt Practices Act, or the FCPA, the UK's Bribery Act 2010, or the UK Anti-Bribery Act; laws regulating the confidentiality of sensitive personal information and the circumstances under which such information may be released and/or collected, such as the Health Insurance Portability and Accountability Act of 1996, or HIPAA, the Health Information Technology for Economic and Clinical Health Act, or HITECH Act, and the European Union General Data Protection Regulation, or GDPR; and healthcare reform laws, such as the Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act of 2010, which the company refers to together as PPACA, which include new regulatory mandates and other measures designed to constrain medical costs, as well as stringent new reporting requirements of financial relationships between device manufacturers and physicians and teaching hospitals. The company's products are also subject to approval and regulation by foreign regulatory and safety agencies. For example, the EU has adopted the EU Medical Device Regulation (the EU MDR) and the In Vitro Diagnostic Regulation (the EU IVDR), each of which impose stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements, quality systems and post-market surveillance. Manufacturers of approved medical devices had until May 2021 to meet the requirements of the EU MDR and had until May 2022 to meet the EU IVDR. Complying with the requirements of these regulations has required the company to, and may continue to require it to, incur significant expenditures. Seasonality Worldwide sales, including the U.S. sales, do not reflect any significant degree of seasonality; however, customer purchases of the company's GYN Surgical products have been historically lower in the company's second fiscal quarter compared to its other fiscal quarters. The company's respiratory infectious disease product line (including its assays for the detection of SARS-CoV-2) within its Diagnostics segment is also subject to significant seasonal and year-over-year fluctuations. In addition, the summer months, which occur during the company's fourth fiscal quarter (year ended: September 30, 2023), typically have had lower order rates internationally for most of its products. History Hologic, Inc. was incorporated in 1985. The company was incorporated in 1985.