Hologic Encourages Health Professionals to Get the Facts About Women’s Imaging at RSNA 2010

Hologic Technologies Help Bring Imaging Excellence and Clinical Confidence to Hospitals and Imaging Centers Across the World

BEDFORD, Mass., Nov. 10, 2010 /PRNewswire-FirstCall/ — Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, will focus on products that are the future of women’s imaging at the Radiological Society of North America (RSNA) meeting at McCormick Place in Chicago, November 28 through December 2, 2010.

Hologic offers clinicians the tools they need to spot, diagnosis and treat cancer or detect osteoporosis while they can still do something about it and the ability to treat a woman at every stage of her life, not just the disease. Over the years radiologists, surgeons, and radiation oncologists have come to rely on Hologic solutions and have made Hologic a leader in digital mammography, breast magnetic resonance imaging (MRI), breast biopsy, accelerated partial breast irradiation and osteoporosis assessment.

With a footprint of 16,000 sq. ft. (1,500 sq. meters) in the South Building of McCormick Place, the Hologic RSNA exhibit ranks 5th in overall size of the 706 booths at this year’s meeting. Sixty thousand professionals are expected to attend RSNA 2010, where 4,200 scientific papers and educational exhibits, and 300 refresher courses will be presented.

Breast Screening and Diagnostic Systems

The November FDA Mammography Quality Standards Act (MQSA) scorecard reports that over 70% of the 8,643 breast imaging sites in the U.S. now have at least one digital mammography system. The Hologic Selenia® system leads the industry in U.S. system installs with more than all the other digital mammography vendors combined.

The power of digital imaging creates new possibilities that will enable us to see cancers earlier than ever before. One area that is expected to deliver on this promise is digital breast tomosynthesis. The Selenia® Dimensions® three-dimensional (3D) breast tomosynthesis system directly addresses the primary limitations of 2D digital alone mammography — the superimposition of normal breast tissue.

Launched in Europe in September 2008, Selenia Dimensions breast tomosynthesis is poised to revolutionize how breast cancer is detected. It delivers the exquisite 2D images the industry has come to expect from Hologic and, for the first time ever, allows radiologists to offer their patients a conventional digital mammogram and a tomosynthesis exam — all under one compression, in just seconds.

Hologic has commercial breast tomosynthesis systems installed in over two dozen countries including Canada and Mexico. In September the Radiological Devices Panel of the U.S. Food and Drug Administration (FDA) voted unanimously that Hologic demonstrated both the effectiveness and safety of the Selenia Dimensions system. The Panel also voted in favor that the benefits of this new technology outweigh the risks.

In 2010 Hologic and Barco, a global display and visualization provider, are working with the RSNA organization to deliver a series of hands-on digital mammography and breast tomosynthesis workshops during the weeklong meeting. Five hundred radiologists will benefit from this highly popular self-assessment educational workshop. Registration information may be found on the RSNA website.

Breast MRI

With the acquisition of Sentinelle™ Medical Inc. Hologic adds a suite of breast MRI tools to its best-in-class women’s health portfolio. The company believes MRI is an important standard of care in breast screening for women indicated as having a high risk of developing breast cancer.

The Sentinelle Breast MRI coil comes in two configurations: A design award-winning patient stretcher with integrated breast MRI coils, and a tabletop configuration leveraging the same open access features of the patient stretcher. Both patient support configurations are designed to provide greater access for positioning and intervention, optimal patient comfort and improved workflow. The innovative combination of the Sentinelle breast MRI coil’s unique patient support and patented Variable Coil Geometry™ feature offers technological advances not available in traditional tabletop coils. Unlike competitive breast coils, the Sentinelle Variable Coil Geometry feature allows for the diagnostic coils and biopsy grid positioning to be customized to each patient. This innovation has the potential to improve image quality, decrease set up time, increase patient accommodation and improve access to lesions for biopsy.

The Sentinelle Aegis™ Breast imaging and interventional software is a dedicated plug-in for the Aegis platform software. It offers powerful real-time 4D (3D + time) image processing, combining speed, flexibility, and dedicated breast MRI algorithms. With advanced hanging protocols and dynamic real-time processing, Aegis Breast software is a state-of the-art platform for breast MRI visualization and interventional guidance to multiple targets.

Built on the Aegis software platform, the Sentinelle Navigation system offers a multi-modality approach to correlated image viewing and device guidance. The Navigation system simultaneously displays real time ultrasound images with corresponding images from previously acquired 3D DICOM datasets. Leveraging the increased sensitivity and specificity of MRI, CT or PET images with ultrasound has the potential to yield more dependable results.

Diagnostic Workstations

With the most popular diagnostic workstation on the market today Hologic is ideally positioned to address some of the toughest challenges — controlling costs, increasing productivity and improving quality. Hologic SecurView® diagnostic workstations lead the industry in the transition from analog to a digital environment. Our ImageChecker® CAD system delivers proven performance and has been the leading CAD technology for more than a decade.

Until recently, consistent assessment of breast composition was hampered by widely differing technical factors and the subjectiveness of the reviewer. The Quantra® volumetric assessment tool is a break-through technology designed to estimate volumes in the breast and calculate the volumetric fraction of fibroglandular tissue. The Quantra tool uses details of the x-ray imaging chain to quantify fibroglandular tissue in the breast. Quantra software aggregates volumetric measurements from each view in a study into a simple, concise assessment for each breast.

Breast Biopsy Solutions

If a suspicious lesion is detected, Hologic supports the next clinical steps — biopsy and intervention. RSNA attendees are invited to discover the many ways Hologic can help deliver compassionate, clinically effective alternatives to open surgical breast biopsy. From our ATEC®, Eviva® and Celero® breast biopsy devices to our new Eviva upright biopsy system and our ergonomically engineered MultiCare® Platinum breast biopsy table with the latest in patient comfort features, we bring more compassionate care to healthcare providers the world over. New this year, we are featuring our work in progress, the Abrivo™ breast biopsy device and Affirm™ breast biopsy guidance system. The Affirm stereotactic-guided biopsy device is specifically designed for the Selenia Dimensions system. Each Hologic breast biopsy solution is designed to improve precision and increase control while collecting the best possible tissue samples.

The SecurMark® family of biopsy site markers now offers three new distinct shapes. The SecurMark biopsy site markers are comprised of two components; one is a bio-absorbable suture-like netting material and the other is a permanent bio-compatible titanium or stainless steel marker. In addition, the Hologic biopsy site marker family includes TriMark® and CeleroMark™ markers.

Should cancer be detected in its early stages, many women are candidates for the Hologic MammoSite® radiation therapy system, a unique and welcomed clinical option, and a patient-friendly alternative to traditional whole breast radiation. The November 2010 release of five-year results from the American Society of Breast Surgeons (ASBS) MammoSite® Breast Brachytherapy Registry Trial was a significant milestone for MammoSite and adds further clinical support for the use of accelerated partial breast irradiation in appropriate patients.

Patient Comfort

For added comfort, the MammoPad® breast cushion is designed to offer a softer, warmer mammogram to help ease a patient’s fear of mammography-associated pain, allowing the technologist to obtain more of the chest wall in the image and ensure even compression of the breast. The MammoPad cushion, which can be used with both digital and analog mammography, is radiolucent and does not require additional dose. New this year is a change in color for MammoPad to pink. The new color of MammoPad not only brings a more aesthetically pleasing look, but also a potentially greater influence on a patient’s ability to relax.

Bone Health

For many years Hologic has set the gold standard in osteoporosis assessment. Now we are expanding our solutions to address the continuum of skeletal health care, from prevention to intervention. Just as we are leading the way in women’s health imaging solutions, we are raising the bar in skeletal health imaging.

Discovery™, our most advanced QDR™ series bone densitometer, offers exquisite imaging and rapid assessment of the most important risk factors for osteoporotic fracture: bone density and vertebral fracture. Hologic’s OnePass™ single sweep linear scanning enables superior image quality and unparalleled precision in just seconds.

Hologic was the first manufacturer to receive FDA clearance for the new World Health Organization FRAX® 10-year fracture risk calculator. While the T-score remains the standard for diagnosing osteoporosis, the FRAX calculator breaks new ground enabling healthcare providers to identify patients with a high risk of experiencing bone fractures within a period of 10 years. By combining 11 of the highest risk factors, including age, personal, and family history of fractures, country-specific life expectancy and country-specific fracture data, the FRAX calculator identifies patients who are at high risk of fracture but would not be candidates for preventative therapy using the traditional T-score.

At RSNA 2010 Hologic will highlight Advanced Body Composition™ assessment software — commercial in Europe and awaiting FDA clearance in the U.S. The Advanced Body Composition Assessment feature on Discovery combines rapid acquisition of the total body with comprehensive reporting and the new National Health and Nutrition Examination Survey (NHANES) reference data. The new color displays of fat and lean distribution combined with the new trending report are valuable tools for the clinician.

The Fluoroscan® InSight system is the original and most sought after mini C-arm system on the market. Now the new Fluoroscan InSight mini C-arm is more versatile, efficient and cost effective than ever before. Designed specifically for orthopedic and other extremity surgeons, the Fluoroscan InSight system is designed to offer maneuverability, high definition (HD), low-dose fluoroscopy images, and automated adjustments that deliver the optimum image every time, for every patient.

Award Winning Service

Hologic’s commitment to supporting customers does not end once a product is delivered. We are committed to delivering the highest quality products and service, acting with the utmost integrity and not just meeting, but exceeding customer expectations. How are we doing?

The recently released 2010 IMV ServiceTrak™ Imaging for X-Ray Mammography Systems report notes that Hologic service out-scored the industry average in 25 of the 39 service attributes measured, is top-rated for 22 attributes, and achieved a rating at or above 5.0 (“very good”) on all 30 of the ratings attributes. Of particular note, Hologic scored highest on the reliability of our detectors, probability of repurchase, our ability to drive industry standards, and our image quality. Additionally, it was the 3rd year in a row that Hologic was rated highest in overall manufacturer performance and overall system performance.

On the journey from images to answers, Hologic offers the finest screening, compassionate diagnosis, and confident treatment solutions for women — every step of the way.

About Hologic, Inc.

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic’s core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, breast magnetic resonance imaging, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications. For more information, visit www.hologic.com.

Hologic, Advanced Body Composition, Aegis, Affirm, ATEC, CeleroMark, Dimensions, Discovery, Eviva, Fluoroscan, ImageChecker, InSight, MammoPad, MammoSite, OnePass, QDR, Quantra, SecurMark, SecurView, Selenia, Sentinelle TriMark, Variable Coil Geometry and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. FRAX is a trademark of the World Health Organization.

Forward Looking Statement Disclaimer

This News Release contains forward-looking information that involves risks and uncertainties, including statements about Hologic’s plans, objectives, expectations and intentions. Such statements include, without limitation, statements regarding the expected performance and benefits of Hologic products and products under development. There is no guarantee that such products will achieve benefits described herein and that such benefits will replicated in particular manner with respect to an individual patient as the actual effect of the use of the these products can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated. Factors that could cause actual results to materially differ include, without limitation: risks inherent in the development of new products and the enhancement of existing products, including technical and regulatory risks, such as the ability to obtain FDA approval or clearances to market products developed, cost overruns and delays; the risk that newly introduced products may contain undetected errors or defects or otherwise not perform as anticipated; Hologic’s ability to predict accurately the demand for its products and to develop strategies to address its markets successfully; technical innovations that could render products marketed or under development by Hologic obsolete; competition; and reimbursement policies for the use of Hologic’s products. Other factors that could adversely affect Hologic’s business and prospects are described in Hologic’s filings with the Securities and Exchange Commission. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Hologic’s expectations or any change in events, conditions or circumstances on which any such statement is based.

Child Abuse Linked to Increased Risk for Type 2 Diabetes in Adults

November 10, 2010 — Women who experience physical or sexual abuse as children or adolescents are at significantly increased risk of developing type 2 diabetes, a large, longitudinal cohort study suggests. Furthermore, investigators found there is a dose response relationship such that the more severe the abuse, the greater the risk.

The latest findings from the Nurses Health Study II show moderate or severe physical abuse was associated with a 26% to 54% higher risk for diabetes in adulthood. Unwanted sexual touching was associated with a 16% higher risk for the disease. Forced sexual activity before adulthood carried a 34% increased risk if it occurred once and but carried a 69% greater risk if it occurred more frequently.

“Although there was no evidence of a multiplicative, synergistic impact of experiencing both physical and sexual abuse, women who experienced both types of abuse had higher absolute risks of diabetes than expected from physical or sexual abuse alone.

“Girls who experience both types of abuse may suffer more severe abuse, more emotionally damaging abuse, or more chronic abuse than girls who experienced abuse of one type,” the researchers, led by Janet Rich-Edwards, ScD, director of developmental epidemiology at the Conners Center for Women’s Health, Brigham and Women’s Hospital, Boston, Massachusetts, write.

The study was published online November 9 in the American Journal of Preventive Medicine.

According to investigators there is a considerable amount of research examining the psychological sequelae of childhood abuse but few studies examining lifelong physical consequences, with 1 exception.

The researchers note that there has been a consistently reported link between child abuse and adult obesity and evidence indicating that child abuse leads to overweight.

The study authors add that because obesity is a major risk factor for type 2 diabetes, it may be that early abuse may lead to the disease via this pathway. They also note that experimental and observational research suggests that “early trauma may cause lasting dysregulated stress responsivity, which may link child abuse with diabetes through physiologic pathways independent of adiposity.”

According to investigators, earlier studies examining childhood trauma and diabetes have been limited by small sample sizes, cross-sectional design, unvalidated or nonspecific metabolic outcomes, or cursory assessments of abuse history.

To examine the extent to which child physical or sexual abuse is associated with type 2 diabetes, the researchers examined data from 67,853 women participating in the Nurses’ Health Study II.

Established in 1989, the cohort has been followed by biennial mailed questionnaires asking about risk factors and disease incidence. In 2001 a Violence Questionnaire was sent to 91,297 study participants and 67,853 individuals responded. The investigators then examined reported lifetime abuse in 2001 and corresponding risk for diabetes from 1989 through 2005.

More than half (54%) of participants reported mild to severe physical abuse as a child or teen and 34% reported experiencing sexual abuse. Adjusted analyses revealed that compared with women who reported no physical abuse, the hazard ratios (HRs) were 1.03 (95% confidence interval [CI], 0.91 – 1.17) for mild physical abuse, 1.26 (95% CI, 1.14 – 1.40) for moderate physical abuse, and 1.54 (95% CI, 1.34 – 1.77) for severe physical abuse.

Compared with women who reported no childhood or adolescent sexual abuse, the HRs were 1.16 (95% CI, 1.05 – 1.29) for unwanted sexual touching, 1.34 (95% CI, 1.13 – 1.59) for a single episode of forced sexual activity, and 1.69 (95% CI, 1.45 – 1.97) for repeated forced sex.

“The more severe the reported abuse, the higher the woman’s risk of developing type 2 diabetes as an adult,” Dr. Rich-Edwards said in a statement.

The investigators report that adult body mass index accounted for 60% of the association of child and adolescent physical abuse and 64% of the association of sexual abuse with diabetes.

“Interpersonal violence is a prevalent and understudied threat to women’s health,” said Dr. Rich-Edwards. “Since child abuse predicts later obesity, and obesity is one of the primary causes of chronic disease, our study demonstrates just one of many potential health risks associated with childhood abuse.”

The investigators note that there is a need for further investigation of potential associations between abuse of girls and women with health.