Profile: Hologic Inc (HOLX.OQ)
22.86USD
1 Aug 2013
$0.16 (+0.70%)
$22.70
$22.88
$23.24
$22.72
984,447
895,663
$23.96
$18.46
Hologic, Inc., incorporated on January 18, 1990, is a developer, manufacturer and supplier of diagnostics products, medical imaging systems and surgical products to serving the healthcare needs of women. The Company operates in four segments: Breast Health, Diagnostics, GYN Surgical and Skeletal Health. 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. On August 1, 2012, the Company acquired Gen-Probe Incorporated (Gen-Probe). Gen-Probe is engaged in molecular diagnostics products and services, which are used to diagnose human diseases, screen donated human blood and test transplant compatibility. In March 2013, it announced that it has completed its sale of the LIFECODES business unit to Immucor, Inc.
The Company's breast health products include a range of breast imaging and related products and accessories, including digital and film-based mammography systems, magnetic resonance imaging (MRI), breast coils, computer-aided detection (CAD), for mammography and MRI, minimally invasive breast biopsy devices, breast biopsy site markers, breast biopsy guidance systems, breast imaging comfort pads, and breast brachytherapy products. The Company offers a range of diagnostic products which are used to aid in the diagnosis of human diseases and screen donated human blood. The Company's molecular diagnostics products include the Company's APTIMA family of assays, its Invader chemistry and advanced instrumentation (PANTHER, TIGRIS and HTA). The APTIMA family of assays is used to detect the common sexually transmitted diseases (STDs), chlamydia and gonorrhea, certain high-risk strains of the human papillomavirus (HPV), and Trichomonas vaginalis, the parasite that causes trichomoniasis. The Company's diagnostics products also include the ThinPrep System, which is used in cytology applications, such as cervical cancer screening, and the Rapid Fetal Fibronectin Test, which assists physicians in assessing the risk of pre-term birth. In blood screening, the Company develops and manufacture the PROCLEIX family of assays, which is used to detect the human immunodeficiency virus (HIV), the hepatitis C virus (HCV), the hepatitis B virus (HBV) and the West Nile virus (WNV), in donated human blood. The Company's GYN surgical products include the NovaSure Endometrial Ablation System (NovaSure), and the MyoSure Hysteroscopic Tissue Removal System (MyoSure). The NovaSure system involves an invasive procedure for the treatment of heavy menstrual bleeding. The MyoSure system is a tissue removal device that is designed to provide transcervical or incision-less removal of fibroids and polyps within the uterus. The Company's skeletal health products include dual-energy X-ray bone densitometry systems, an ultrasound-based osteoporosis assessment product, and the Company's Fluoroscan mini C-arm imaging products.
Breast Health Products
The Company's full field digital mammography systems are based on the Company's DirectRay digital detector, which employs an amorphous selenium photoconductor to directly convert x-ray photons into an electrical signal. The Company's Dimensions platform includes a mammography gantry incorporating the Company's DirectRay digital detector capable of performing both two dimension (2D) and three dimension (3D) image acquisition and display. The open architecture of the system's design provides for full integration with existing enterprise Picture Archiving and Communications Systems (PACS), and Radiology Information Systems (RIS). The Selenia product family includes the Selenia base configuration, the Selenia S configuration, the Selenia Performance and the Selenia Encore, each of which offer customers performance capabilities and product costs.
The Company's screen-film mammography systems include the Company's LORAD M-IV system. The images captured by digital mammography systems are transmitted electronically for review by a radiologist at a work station. The Company developed the SecurViewDX breast imaging softcopy workstation, approved for interpretation of digital mammograms from vendors, as well as images from other diagnostic breast modalities. The Company also developed the SecurViewRT workstation, a technologist workstation enabling bi-directional exchange of electronic communications between the reviewer and the technologist. The Company has developed CAD software tools for its mammography and MRI products. The Company also markets an MRI CAD product, which manages the data set from an MRI procedure, designed to improve data workflow for the physician and provide analytical tools to aid in the identification and evaluation of the extent of disease.
The Company provides clinicians with the choosing upright or prone systems for breasts biopsy by offering three stereotactic breast biopsy guidance systems, the MultiCare Platinum dedicated, prone breast biopsy table, the StereoLoc II upright attachment, and the Affirm upright attachment. The StereoLoc II attachment is used in conjunction with the Company's M-IV series of screen-film mammography systems and its Selenia full field digital mammography systems. The Affirm upright attachment is employed with the Company's Dimensions systems. The Company offers a range of products for breast biopsies and biopsy site marking. The Company's breast biopsy portfolio includes two types of tethered breast biopsy products, the Automated Tissue Excision Collection (ATEC), and Eviva devices. The ATEC vacuum-assisted breast biopsy device can be used under standard imaging guidance modalities whereas the Company's Eviva vacuum-assisted breast biopsy device is used under stereotactic x-ray guidance. In addition to ATEC and Eviva products, the Company also offers the Celero device, a non-tethered (no separate console), vacuum-assisted, spring-loaded, disposable core biopsy device, which is used exclusively under ultrasound-guidance. All of the Company's breast biopsy devices have been designed to accommodate a broad spectrum of patients, as well as hard-to-reach lesions in the axilla, near the chest wall, near implants or behind the nipple.
The MammoSite Radiation Therapy System is a breast brachytherapy technology, which offers accelerated partial breast irradiation (APBI), therapy to treat breast cancer. The MammoSite ML system allows radiation oncologists to shape the radiation dose for typical cases. The MammoSite ML device has a central lumen, and three offset lumens parallel to the central lumen. The Company's mammography related products include a MammoPad breast cushion. The cushion's grip-like surface also holds breast tissue in place to improve breast positioning.
The Company's Hologic Hitec-Imaging GmbH subsidiary is the Company's supplier of the amorphous selenium photoconductor coatings employed in its Selenia and Dimensions full-field digital mammography detectors. Hitec-Imaging also develops, manufactures, and sells non-medical selenium and organic photoconductor materials for use in a range of other electro photographic applications, including copying and printing. The Company's Sentinelle Medical Inc. (Sentinelle Medical) subsidiary develops, manufactures and markets a range of breast MRI coils. In addition, the Company also sells an MRI CAD workstation.
The Company competes with GE, Siemens, Philips, Planmed, Agfa, Carestream Health, Fuji, IMS Giotto, Toshiba, Devicor Medical Products, C.R. Bard, CareFusion, Sanarus, Intact Medical and Cianna Medical.
Diagnostic Products
The Company offers its APTIMA family of assays, which includes the APTIMA Combo 2 assay for the detection of chlamydia and gonorrhea, the standalone APTIMA CT and APTIMA GC assays for the detection of Chlamydia and gonorrhea, respectively, the APTIMA HPV assay for the detection of 14 sub-types of HPV associated with cervical cancer, and the APTIMA Trichomonas assay for the detection of Trichomonas vaginalis. The Company's APTIMA products integrate the Company's transcription-mediated amplification (TMA), technology, target capture technology, and its hybridization protection assay (HPA), and dual kinetic assay (DKA), technologies, to produce refined amplification assays.
The Company has developed capture techniques to immobilize nucleic acids on magnetic beads by the use of a capture probe, which attaches to the bead and to the target nucleic acid. The Company uses a magnetic separation device to concentrate the target by drawing the magnetic beads to the sides of the sample tube, while the remainder of the sample is washed away and removed. The Company's TMA technology is a transcription-based amplification system, which uses two different enzymes to drive the process. The first enzyme is a reverse transcriptase that creates a double-stranded deoxyribonucleic acid (DNA) copy from a ribonucleic acid (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.
In the hybridization protection assay (HPA) process, the acridinium ester (AE), molecule is protected within the double-stranded helix, which is formed when the probe binds to its specific target. The Company's dual kinetic assay (DKA) technology uses two types of AE molecules: one that flashes and another one that glows. By using DKA technology, the Company has created nucleic acid test (NAT), assays which can detects two separate targets simultaneously.
The Company has developed and develops instrumentation and software designed for performing certain of its diagnostic assays, including the APTIMA family of assays and the PROCLEIX family of assays in the blood screening market. The Company also provides technical support and instruments service to maintain these instrument systems in the field. The Company's instrumentation includes the TIGRIS system, an integrated, fully-automated testing instrument for laboratories which is approved for use with a range of the Company's APTIMA and PROCLEIX assays, the PANTHER instrument system, an integrated, fully automated testing instrument for low- to mid-volume laboratories, and its semi-automated direct tube sampling (DTS) instruments which are used to run a range of infectious disease and blood screening assays. In May 2012, the Food and Drug Administration (FDA) cleared the PANTHER system to run the Company's APTIMA Combo 2 assay for the detection of chlamydia and gonorrhea in the United States. The Company also sells PANTHER systems to Roka Bioscience, Inc. for uses in certain industrial markets. In October 2012, the Company received FDA approval of its APTIMA HPV 16 18/45 Genotype Assay for use on its TIGRIS system.
The Company's Invader chemistry platform is a DNA probe-based system for sensitive detection of nucleic acid sequences. It is an accurate and specific method for detecting single-base pair changes, insertions, deletions, gene copy number, infectious agents, and gene expression. The Company offers two HPV tests using the Invader chemistry: the Cervista HPV HR and the Cervista HPV 16/18. These tests employ the Company's Invader technology and are performed out of the ThinPrep PreservCyt collection vial. Both the Company's APTIMA and Cervista HPV HR tests have been approved for triaging women with undetermined cervical cytology and co-testing with cervical cytology for women 30 years and older. In December 2011, the Company announced that the FDA approved its Cervista High Throughput Automation System, which the Company refers to as the HTA system, for uses with its Cervista HPV HR test. The Cervista HTA system automates the DNA extraction and detection steps of the Cervista HPV HR test. Other current clinical diagnostic offerings based upon the Company's Invader chemistry include a molecular assay to identify patients who may be at risk of adverse reaction to the chemotherapy drug Camptosar (irinotecan) by detecting and identifying specific mutations in the UGT1A1 gene that have been associated with that risk; products to assist in the diagnosis of cystic fibrosis, cardiovascular risk and other diseases. In addition, the Company sells products to the Agricultural Biotechnology market. The Company also has an active out-licensing and partners program in areas outside of its core business, which allows the Company to further realize the value of its Invader chemistry platform.
The ThinPrep System is a used method for cervical cancer screening in the United States. The ThinPrep System consists of the ThinPrep 2000 Processor, ThinPrep 3000 Processor, ThinPrep 5000 Processor, ThinPrep Imaging System, and related reagents, filters and other supplies, such as the ThinPrep Pap Test and the Company's ThinPrep PreservCyt Solution. The Rapid Fetal Fibronectin Test is a single-use disposable test used to determine a woman's risk of preterm birth by detecting the presence of a specific protein, fetal fibronectin, in vaginal secretions during pregnancy.
The Company develops and manufactures the PROCLEIX family of assays, which is marketed and sold globally by Novartis, its blood screening collaborator. The PROCLEIX family of assays includes the HIV-1/HCV assay which simultaneously detects HIV type-1, or HIV-1, and HCV in donated blood, plasma, organs and tissues, the Ultrio and Ultrio Plus assays, which detect HIV-1, HCV and HBV in donated blood, plasma, organs and tissues, the Ultrio Elite assay which simultaneously detects HIV-1, HIV type-2, or HIV-2, HBV and HCV in donated blood, plasma, organs and tissues, and the WNV assay, which detects West Nile Virus in donated blood, plasma, organs and tissues.
The Company offers a range of products in the infectious disease space, including a range of assays for the detection of certain respiratory and gastrointestinal diseases. The Company's infectious disease products include multiplex real-time PCR assays to detect and differentiate various influenza types and viruses, a real-time PCR assay to detect the Tuberculosis pathogen, and a rapid assay for the direct detection of Streptococcus pyogenes in one hour from a throat swab. The Company offers APTIMA assays for the qualitative detection of HIV-1 and HCV. In addition, the Company sells analyte specific reagents for quantitative HCV testing in the United States through its collaboration with Siemens Healthcare Diagnostics, Inc. (Siemens). The Company is developing quantitative viral assays to run on its PANTHER instrument system. In February 2012, the FDA approved the Company's PROGENSA PCA3 assay for sale and marketing in the United States. The PROGENSA PCA3 assay is to be used, in conjunction with other patient information, to help guide repeat biopsy decisions for men who have had one or more prior negative biopsies.
As a result of the Company's acquisition of Gen-Probe, the Company’s transplant diagnostics business, which the Company refers to as its LIFECODES business, comprises its human leukocyte antigen (HLA), products and related assays. HLA testing, also known as HLA typing or tissue typing, identifies antigens on white blood cells, which determine tissue compatibility for organ transplantation. HLA typing is performed for kidney, bone marrow, liver, pancreas, and heart transplants. The Company offers a range of multiplexed assays in the field of transplant diagnostics pursuant to its development and supply agreement with Luminex Corporation. The Company also offers a range of HLA antibody detection products under its LIFECODES brand, as well as a number of other HLA-related testing products, including serological typing trays, enzyme immunoassays, and a range of molecular typing products for donor-recipient matching and patient monitoring.
The Company competes with Becton, Dickinson and Company, Abbott Laboratories, Siemens, bioMerieux, Cepheid, Life Technologies Corporation, Luminex Corporation, Qiagen, Roche Diagnostics Corporation and Chiron Corporation.
GYN Surgical Products
The NovaSure system involves an invasive procedure, which allows physicians to treat women suffering from menstrual bleeding. The 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 bleeding. The NovaSure disposable device is a hand-held, single-use device, which incorporates a flexible gold-plated mesh electrode used to deliver the RF energy during the NovaSure procedure. The NovaSure RF Controller generates and delivers the RF energy customized for each patient, monitors several critical treatment and safety parameters, and controls other aspects of the procedure.
The MyoSure system is designed to provide hysteroscopic removal of fibroids located just below the lining of the uterus, as well as uterine polyps. 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 tissue removal device is single-use and features simultaneous tissue cutting and removal. The device incorporates a rotating cutting blade designed to remove a three centimeters fibroid in less than 10 minutes. The towerfree hysteroscopy system (THS) is a hysteroscopy system, which allows for visualization and inspection of the uterine cavity. The system consists of a video platform and hysteroscope instrumentation. The components of the THS system (including a light source, camera, monitor and image capture system) have been integrated into a compact and portable unit. For those customers who want to perform diagnostic hysteroscopy, THS offers a diameter single flow sheath, which reduces the need for cervical dilation and provides a tool for visualization of the uterine cavity. The Aquilex fluid control system is a product, which measures the inflow and outflow of fluid from the patient during hysteroscopic procedures and is designed to reduce procedure and anesthesia time associated with hysteroscopic procedures while providing visualization to the surgeon.
The Company competes with Johnson & Johnson, Boston Scientific and CooperSurgical, Smith & Nephew, Richard Wolf, Stryker, ACMI/Olympus and Karl Storz.
Skeletal Health Products
The Company's QDR x-ray bone densitometers incorporate dual-energy x-ray technology to assess bone density of the important fracture sites, the spine and hip. The Company offers a range of bone densitometers with features and options to addresses the requirements of its diverse customer base. The Company has developed and sells an ultrasound bones analyzer, which assesses the bone density of the heel, which can assist in initial screening for osteoporosis.
The Company manufactures and distributes Fluoroscan mini C-arm imaging systems. Mini C-arms provide x-ray imaging, with images at radiation levels and at a cost below those of conventional x-ray and fluoroscopic equipment. Mini C-arm systems are used by orthopedic surgeons to perform invasive surgical procedures on a patient's extremities, such as the hand, wrist, knee, foot and ankle.
The Company competes with GE.
Company Address
Hologic Inc
35 Crosby Drive
BEDFORD MA 01730
P: +1781.9997300
F: +1302.6365454
Company Web Links
| Name | Compensation |
|---|---|
David LaVance |
-- |
John Cumming |
3,879,600 |
Glenn Muir |
2,149,620 |
Jay Stein |
1,590,100 |
Mark Casey |
1,224,850 |

