EZbra breast dressing facilitates easy and safer recovery after various breast procedures

EZbra Advanced Wound Care Ltd is about to launch its EZbra– a sterile, disposable, all-in-one breast dressing in US markets. The unique dressing aims to address the various needs and challenges that patients face while recovering from breast surgery. Founded by Efrat Roman– EZbra is a women-led start-up based in Israel and aims to design innovative wound care products for breast and chest surgery.

Every year, about 13 million breast procedures are performed globally, yet there is no uniform standard for breast dressing. EZbra is designed to meet the needs of surgeons and patient both.

The design enables the operating surgeons to customize it according to each patient and procedure need. EZbra allows for stabilization of breast implants and holds drain in addition to offering tailored compression level and adaptation to individual breast anatomy.

It is free from latex and does not adhere to the skin wound providing protection from Medical Adhesive-Related Skin Injuries (MARSI) and other adhesive related complications.

At the same time, it helps patients to ease the healing process and improve the body image. It can be worn under any top and hugs the body snuggly providing feminine shape and defined anatomy. It is easy to apply with detailed instruction so that patients can change at any time in the privacy of their own home. It comes in 3 different sizes – to cover a range of breast and body shapes and varying bra sizes.

“We are proud to bring our product to the US market and to introduce our solution to surgeons and their HCP staff to provide patients with a tailored, sterile and disposable breast dressing option,” said Efrat Roman, a breast cancer survivor, and EZbra CEO. “Our goal is to offer a quality post-operative option while providing patients with the independence, dignity, and self-esteem they deserve during recovery.”

Here is a video showing how to apply the EZbra dressing

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FDA grants fast review for Roche's Tecentriq in tough-to-treat Triple Negative Breast cancer

Roche/Genentech’s new drug Tecentriq (atezolizumab) wins FDA priority review as a part of the regimen for the treatment of tough-to-treat Triple Negative Breast Cancer (TNBC). The drug will be used in combination with Celgene chemo med Abraxane (nab-paclitaxel) in previously untreated patients whose tumors express biomarker PD-L1.

A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

Triple-negative breast cancer is the term used to describe breast cancers that lack estrogen- and progesterone-receptor expression and do not overexpress human epidermal growth factor receptor 2 (HER2). It is more aggressive and harder to treat, it is also more likely to spread and recur. Approximately 15% of breast cancers are triple-negative based on the results of diagnostic tests.

The company’s supplemental Biologics License Application (sBLA) is based on the results of phase III IMpassion130 study, involving 902 patients with advanced breast cancer. The results demonstrated that Tecentriq plus nab-paclitaxel as an initial (first-line) treatment for unresectable locally advanced or metastatic TNBC increased the median progression-free survival (PFS) to 7.2 months instead of 5.0 months as compared to nab-paclitaxel alone group. In a subgroup analysis of PD-L1-positive population, the median survival was further increased to 7.5 months vs. 5.0 months.

The drug combination improved clinically meaningful overall survival in the PD-L1-positive population (25.0 months vs. 15.5 months). The safety profile of the drug combination was as per that reported for individual drugs. Currently, Genentech has seven ongoing phase III studies investigating Tecentriq in patients who are in various stages of TNBC.

The results of the study were presented at the European Society for Medical Oncology (ESMO) Congress and published in the October issue of New England Journal of Medicine.

“Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer. People need more options for this type of breast cancer, which is particularly difficult to treat,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive, metastatic triple-negative breast cancer as soon as possible.”

It is expected that FDA will give its decision on approval by March 12, 2019. If approved, this will be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic TNBC. 

Genentech press release

Full Text-New England Journal of Medicine

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FDA approves PARP inhibitor talazoparib for BCRA-positive, HER2‑negative advanced breast cancer

The US Food and Drug Administration (FDA) approved talazoparib (Talzenna, Pfizer Inc.) for patients with advanced BCRA-positive, HER2‑negative locally advanced or metastatic breast cancer. Talazoparib is administered orally and belongs to the class of drugs called poly (ADP-ribose) polymerase (PARP) inhibitors, which block the enzymes involved in repairing of damaged DNA.

BRCA mutation is responsible for 25-30% of all hereditary breast cancers and 5-10% of all breast cancers. The FDA has also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) to identify patients with breast cancer with deleterious or suspected deleterious germline BRCA mutation who are eligible for talazoparib.

BRACAnalysis CDx is defined as an in vitro diagnostic device created for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA.

The approval is based on results of international EMBRACA (NCT01945775) trial, an open-labeled, RCT involving 431 patients with gBRCAm HER2‑negative locally advanced or metastatic breast cancer. The other inclusion criteria were having received prior treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant, and/or metastatic treatment setting. Patients were excluded if they have received more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease.

The patients were randomized to receive 1 mg oral talazoparib or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). The primary endpoint was progression-free survival (PFS), as assessed by a blinded independent central review.

At the median follow-up of 11.2 months, talazoparib reduced the risk of disease progression or death by 46% versus chemotherapy. Patients in talazoparib arm demonstrating median survival of 8.6 months as opposed to 5.6 months in the chemotherapy arm.

Patients on talazoparib also showed higher objective response rate (ORR) as compared to patients on other chemotherapy drugs (62.6% vs. 27.2%; odds ratio, 4.99; 95% CI, 2.9-8.8; 2-sided P value <.0001). The FDA defines ORR as the “proportion of patients with a tumor size reduction of a predefined amount and for a minimum period of time,” and ORR is one of the many oncology endpoints for the approval of cancer drugs and biologics.

Most commonly reported side effects of the drug include nausea, headache, fatigue, anemia, neutropenia, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite. The drug also comes with a warning and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression, and embryo-fetal toxicity.

BRACAnalysis CDx also has a diagnostic indication for the detection of deleterious or suspected deleterious mutations in BRCA1 and BRCA2 genes for patients with ovarian cancer to select therapy for olaparib (Lynparza) and/or rucaparib (Rubraca).

FDA approval

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GE Healthcare introduces it's new automated breast ultrasound for dense breast

There could not have been more appropriate time for the launch of GE Healthcare new Invenia Automated Breast Ultrasound (ABUS) 2.0 than October, which is celebrated as breast cancer awareness month. The Invenia ABUS is the only FDA approved 3D ultrasound system for supplemental screening for breast cancer along with mammography.

In conjunction with mammography, it increases the chances of cancer detection in the dense breast by 55%. All breasts are not the same, the density of breast is determined by a proportion of fat and breast tissue—when the percentage of breast tissue exceeds that of fat, breasts are labeled as being dense.

Dense breast tissue and cancer both appear white on mammograms, thereby creating a diagnostic dilemma for the radiologists. It is estimated that about 71% of all breast cancers occur in dense breast and 1 in 3 cancers are missed by mammography. 

In the USA, about 40% of women have dense breast; thereby putting them at increased risk of having breast cancer and detection at a late stage. Early detection of breast cancer increases the chance of cure and patients may void chemotherapy.

The Invenia ABUS uses particular software-based graphics processor to capture operator independent, high-quality images making it possible to reproduce consistent images every time the machine is used. Unlike manual device, the focal zone and grain are automatically adjusted eliminating the inter-operator variability.  All these features enable the Invenia to pick-up small cancers that are predominantly invasive but node negative,  culminating into substantial patient benefits.

Invenia ABUS also provides 2-mm thick coronal slices which allow the operator an efficient visualization of the entire breast for architectural distortions and multifocal disease. With the reconstruction of 2-mm thick coronal slices, it is easy to obtain a persistent orientation and location of the lesions relative to the nipple and to scan the entire breast from the skin to chest wall.

The machine is also designed keeping patients comfort at the forefront. The gentle Reverse Curve™ transducer is designed according to the natural contour of breast allowing full contact and effective compression. The operator can customize the examination by programmable scan protocols to personalize it to patient needs.

The windows 10 provides a user-friendly interface to review, interpret patients' results quickly. Compression time can be shortened once tissue acquisition is complete. The three-view layout and Auto Prior Compare enable the physician to compare the results and focus on a region of interest.

“We believe ABUS can help clinicians find significantly more cancers than mammography alone, especially in women with dense breasts,” said Luke Delaney, general manager of Automated Breast Ultrasound at GE Healthcare, in a published statement. “As breast ultrasound technology continues to advance, we are investing to continually improve image quality, workflow, and patient comfort – all of which contribute to early detection and improved outcomes.”

Here is a video about the Invenia ABUS 2.0 acquisition process

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GE press release

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Weight loss decreases breast cancer risk in postmenopausal women

October is breast cancer awareness month, which an annual campaign to increase the awareness about the deadly disease. With over 2 million new cases every year, it is the most prevalent cancer in women. Although breast cancer runs in families, there are other lifestyle and environmental factors which increase the risk of breast cancer.

Obesity increases the risk of postmenopausal breast cancer; the risk is 1.5 times higher in overweight women and about 2 times in obese women than healthy weight women. The association between weight loss and incidence of breast cancer is inconsistent, and few studies have evaluated the association between the two.

 A recent observational study by Chlebowski RT et al. published in Cancer, the peer-reviewed journal of the American Cancer Society reported that women decreased the risk of breast cancer by 12% if they lost weight in 3 years as compared to the ones whose weight remained stable.

“Obesity is associated with increased risk of incident postmenopausal breast cancer,” Rowan T. Chlebowski, MD, Ph.D., research professor in the department of medical oncology and therapeutics research at City of Hope National Medical Center, and colleagues wrote. “Because approximately one-third of postmenopausal women in the United States are obese, obesity represents a common and potentially modifiable factor related to breast cancer outcome. However, it has not been established that weight loss in postmenopausal women decreases breast cancer incidence or breast cancer mortality.”

The researchers from the Department of Medical Oncology and Therapeutics Research, City of Hope National Medical Center, Duarte, California used data from the Women’s Health Initiative (WHI) Observational Study to study the association.

The study included 61,335 postmenopausal women with no prior history of breast cancer and normal mammogram with body weight and height measured and body mass index (BMI) calculated at baseline and after 3 years.

At the end of 3 years, the analysis was based on 3 weight categories: stable, 5% increase or 5% decrease.

The study participants were between 50 to 79 years, and the mean follow-up duration was 11.4 years, during which the researchers observed 3,061 cases of breast cancer.

Women (n = 8175) who lost weight faced a 12% decreased risk of breast cancer as compared to women whose weight remained stable (n = 41,139) (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.78‐0.98; P = .02). The association remained the same even after adjustment for mammography.

The mean time to develop breast cancer was 6.5 years after the 3-year weight determination.

Women who gained (≥5%) weight (n = 12,021) were not associated with increased risk of breast cancer (HR, 1.02; 95% CI, 0.93‐1.11) but did show a slightly higher incidence of triple‐negative breast cancer (HR, 1.54; 95% CI, 1.16‐2.05).

“Our study indicates that moderate, relatively short-term weight reduction was associated with a statistically significant reduction in breast cancer risk for postmenopausal women,” said Dr. Chlebowski in Wiley press release. “These are observational results, but they are also supported by randomized clinical trial evidence from the Women's Health Initiative Dietary Modification trial where, in a randomized clinical trial setting, adopting a low-fat dietary pattern that was associated with a similar magnitude of weight loss resulted in a significant improvement in breast cancer overall survival. These findings, taken together, provide strong correlative evidence that a modest weight loss program can impact breast cancer.”

Here is the visual abstract of the study.

Abstract

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FDA issues warning against laser and energy-based “vaginal rejuvenation” procedures

Despite their sudden hype and growing popularity, there is no evidence that so-called “vaginal rejuvenation” therapies are either safe or effective, the U.S. Food and Drug Administration warns in a statement today.

The procedures which use energy-based devices—laser and radiofrequency waves both, to reshape and firm the vaginal tissue claim to treat many genitourinary conditions like urinary incontinence, vaginal atrophy, and dyspareunia.

In addition to treating the above conditions, manufactures and healthcare provider also assert that it improves the sex lives of perimenopausal and menopausal women.

In the statement released on Monday FDA Commissioner, Dr. Scott Gottlieb stated, “These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.” 

The procedures are known to cause vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain. The full extent of damage is not recognized as the devices have not been approved for “vaginal rejuvenation.”

FDA has approved and cleared these procedures for destruction of precancerous lesions of cervix and vagina and vaporization of condylomas (genital warts). But the safety and effectiveness of these devices haven’t been studied and confirmed for “vaginal rejuvenation.”

In some cases, women who have undergone treatment for breast cancer are offered these treatments under the false assertion of mitigating their symptoms of early menopause.

FDA has recently notified seven device manufacturers for concerns about the inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are Alma Lasers, BTL Aesthetics, BTL Industries, Cynosure, InMode, Sciton, and Thermigen.

They have 30 days to address the FDA's concerns, and if they fail to do so, FDA may consider enforcement measures.

The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions," Dr. Gottlieb said.

"These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options," he explained.

He further advised, "Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options."

Dr. Gottlieb further assured that FDA will carefully monitor reports of problems associated with "vaginal rejuvenation" procedures and will keep the public informed.

He urged that patients who have suffered adverse effects with the use of these devices should report the complications to  MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Dr. Vanessa Mackay, from the UK's Royal College of Obstetricians and Gynaecologists (RCOG), said: "There is no evidence to suggest that non-surgical 'vaginal rejuvenation' devices are effective in improving vaginal muscle tone or reshaping vaginal tissue. If women are concerned about the appearance or feel of their vagina, they should speak to a healthcare professional. It is important to remember, however, that every woman's vagina is different. Labia are as individual as women themselves and vary in appearance and color.

"To strengthen the muscles around the vagina, women are encouraged to try pelvic floor exercises which can help to improve muscle tone and sensitivity during sex."

FDA Statement

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New 3-D printed, air-powered, biopsy robot that can collect sample inside MRI unveiled

The University of Twente revealed its latest version of world’s most accurate 3D-printed biopsy robot during the Surgical Robot Challenge at the international Hamlyn Symposium in London. The robot is named Sunram 5 and is faster and accurate than its previous self.

Today, most breast biopsies are performed by handheld needles under sonographic guidance, based on previous radiological films. But, many a time the needle placement is not perfect because what was seen on MRI or mammography may look quite different on sonography. Coupled with human error, this may create serious problems such as a malignant lesion may be reported as benign.

MRI scanners are unparalleled in terms of locating lesions, and it would be perfect if a biopsy is taken under their guidance. This would though require a robot small enough to fit beside the patient under MRI robot that could fit. The robot should also be made of a material not influenced by strong magnetic field created by MRI.

Researchers at the Twente University, Netherlands, have tailor-made a robot to above specification. The robot is very small and easily fit under the breast compression device. It is powered by air pressure maintained through external pumps, which also enables it to be under operator control. It is made up of hard plastic except for the MR-conditional needle itself.

The dual speed motors in the updated model have improved the speed so as the robot can reach its target location in about 10 seconds. In case of any technical mishap, a safety mechanism in the device retracts the needle from the breast.

Here is the video showing how the new robot works.

University of Twente press release

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North American Menopause Society (NAMS) video series about important midlife health topics: Hormones and Breast Health

The North American Menopause Society (NAMS) is proud of its comprehensive video series for women on important midlife health topics. All the interviews in the series are hosted by NAM Board of Trustees Member and Immediate Past-President Dr. Marla Shapiro, a Canadian physician who led this exciting initiative. Dr. Shapiro is also the medical consultant for CTV News.

In this video of 2018 series, Dr. Shapiro discusses the very controversial topic of hormones replacement therapy (HRT) and breast cancer with Dr. Stephanie Faubion, Director, Office of Women’s Health at the Mayo Clinic, Rochester, Minnesota.

HRT remains the most effective solution for the relief of menopausal symptoms and is also effective for the prevention of osteoporosis. It is thought to be associated with increased risk of stroke and breast cancer, but the risk has not been yet quantified. Dr. Faubion talks about HRT in various clinical settings, including women who have a family history of breast cancer and those with BRCA mutations.

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Could perioperative NSAIDs treatment markedly reduce metastatic breast cancer recurrence?

Perioperative anti-inflammatory treatment could prevent or reduce the risk of secondary spread of breast cancer after the primary resection surgery according to a paper published April 11 in Journal of Science and Translational Medicine.

The study was conducted in mice but could offer an explanation for the resurgence of the tumor after primary surgery in humans too. It has been a long-known fact that after undergoing lumpectomy or mastectomy, there is metastatic recurrence elsewhere in the body after a year or two.

The cause of this is long been debated, some researchers taking it as the natural progression of disease while others propose that handling of the tumor during surgery release the cancerous cells in the circulation.

The researchers set up an experimental wound healing mice model who had breast cancer. They did not do any surgery or disturbed the primary tumor. The systemic inflammatory response to wound led to new tumor growth at the distant site, which was kept in check by the tumor-specific T cell response. Probably, the wound healing consumed all the T-cells that previously kept a check on tumor cells.

The researchers gave the mice NSAIDs for wound healing and noted that the growth of secondary metastasis was curbed considerably.

Earlier clinical studies have suggested that perioperative anti-inflammatory drugs reduce early metastatic recurrence in breast cancer patients, but no explanation was put forth for the cause.

A 2012 study particularly showed that breast cancer patients given the anti-inflammatory drug ketorolac during surgery were five times less likely to have their cancer spread than people who didn’t get the painkiller

“This represents the first causative evidence of surgery having this kind of systemic response,” Jordan Krall, the first author of the study and a researcher at the Massachusetts Institute of Technology's White Head Institute for Biomedical Research, said in a statement announcing the study's publication.

“Surgery is essential for treating a lot of tumors, especially breast cancer," Krall added. "But there are some side effects of surgery, just as there are side effects to any treatment. We’re starting to understand what appears to be one of those potential side effects, and this could lead to supportive treatment alongside surgery that could mitigate some of those effects.”

It’s not yet clear whether any specific NSAIDs will give more benefit than others, or what’s the best dose or timing to deliver the drug.

Professor Robert Weinberg, the new study’s senior author says, “Mice are not people and therefore this may not translate into clinical practice. Our paper is only intended to alert people to this possibility and to explore whether this mechanism operates as well in humans as we think it might.”

Scientist agrees that more research is needed to investigate an explanation as simple as this, as NSAIDs are routinely used in the peri and postoperative period to ease the pain.

Abstract

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FDA approves first home-based testing for three BRCA mutations

The US Food and Drug Administration (FDA) has approved the first direct-to-consumer tests for three BRCA1 and BRCA2 gene mutations that are most common in people of Ashkenazi (Eastern European) Jewish descent, but people of other racial and ethnic groups can also have them.

This gives the ability to consumers to order the test directly from home without a consultation or order of healthcare provider.

Women who test positive for any of the three mutations are at increased risk of breast and ovarian cancer and men who test positive are at increased risk of breast cancer. A negative test does not rule out the possibility of the presence of other BRCA mutation which can still put you at increased risk of cancer. There are about 1000 BRCA mutations and the test only detects 3 most common ones.

Absence of BRCA mutation does not also signify that the individual is not at risk of any other type of cancers.

Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health said, “This test provides information to certain individuals who may be at increased breast, ovarian or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of DTC genetic tests. But it has a lot of caveats.”  in the FDA’s press release.

He warned the consumers that this test should not be a substitute for your screening tests, annual physicals, and consultation with your physician about genetic tests and other lifestyle factors that may influence your risk of developing cancers.

The test results should also not be the sole basis to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries.

After the test results are available, the individual should consult the physician who can request for additional tests and assess your individual risk of getting breast and ovarian cancer. Most cancers are not caused by the mere presence of these mutations, but they are the result of complex interplay between your genes, environment and lifestyle.

The physician will also advise you about ways of reducing the risk of developing cancer.

The FDA granted the marketing authorization to 23andMe, for this test. The company will report the results as a part of its $199 Health and Ancestry product. The consumers who wish to get tested request for a kit that is mailed to them. The saliva samples are collected at home and mailed back in the same kit. Results are ready in 6-8 weeks’ time and can be viewed online by logging into the account.

In April 2017, 23andMe has already received FDA clearance for at home testing of 10 genetic diseases.

Angelina Jolie famously documented her double mastectomy in The New York Times after testing positive for a BRCA mutation and is often held responsible for rising in inappropriate BRCA testing around the world.

In the wake of the announcement by FDA, we are sure to see a rise in the pool of women with BRCA testing.

FDA press release

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Do not use HRT solely for primary prevention of chronic diseases: USPSTF final recommendation

The US Preventive Services Task Force (USPSTF) recommends against the use of HRT in asymptomatic post-menopausal women solely for preventing chronic diseases in its final statement published yesterday in JAMA.

The recommendation holds good for estrogen alone or combined with progestin and upholds the previous 2012 statement.

The USPSTF statement does acknowledge few benefits of HRT in postmenopausal women such as reducing the risk of fractures and diabetes, but the potential harms outweigh the moderate benefits cited.

Combined use of estrogen and progestin is associated with increased risk of invasive breast cancer, coronary artery disease, venous thromboembolism, stroke, dementia, gallbladder disease, and urinary incontinence.

Use of estrogen alone predisposes the women to greater risk for thromboembolism, stroke, dementia, gallbladder disease, and urinary incontinence.

The recommendations were based on evidence from  Women's Health Initiative (WHI) trials, which were stopped early because of sufficient evidence of serious adverse effects in postmenopausal women.

The USPSTF statement is accompanied by an editorial by Cora E. Lewis, MD, MSPH, from the Division of Preventive Medicine at University of Alabama at Birmingham School of Medicine, and Melissa F. Wellons, MD, MHS, from the Division of Diabetes, Endocrinology and Metabolism at Vanderbilt University Medical Center in Nashville, Tennessee says that although the WHI trial was a observational study, till date no large sufficiently powered trials exist to recommend against the WHI conclusions.

The authors further asserted that these recommendations do not apply to “women who are considering hormone therapy for the management of menopausal symptoms, such as hot flashes or vaginal dryness. It also does not apply to women who have had premature menopause (primary ovarian insufficiency) or surgical menopause.”  

Also, the route of administration considered in the study is oral or transdermal and not creams and rings because those are not generally used for primary prevention of chronic conditions.

The editorial also mentions about the “timing hypothesis” put forward by the American Association of Clinical Endocrinologists/American College of Endocrinology in its July 2017 updated guidelines on menopause.

USPSTF statement stats that there is not sufficient evidence to support the “timing hypothesis” at present. It requires very large, sufficiently powered studies to evaluate the risk/benefit ratio in this specific age group.

At present, few women are on HRT, and physicians consider HRT only for the treatment of menopausal symptoms. Relatively healthy, younger menopausal women with severe climacteric symptoms may be prescribed HRT for symptoms relief and not for chronic disease prevention.

Full Text of  USPSTF guidance
 Editorial

FDA clears Hologic’s Quantra 2.2 Breast Density Assessment Software during routine screening mammography

Hologic Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Quantra 2.2 Breast Density Assessment Software. The software helps radiologists and clinicians to provide information about breast density to women during routine breast cancer screenings.

Quantra standardizes breast density reporting and helps eliminates the visual subjectivity by radiologists, through a proprietary algorithm powered by machine learning. The software classifies the breast tissue into four density categories based on  ACR Breast Imaging Reporting and Data System( ACRBI-RADS®) Atlas 5^th Edition, based on the distribution of fibroglandular tissue  and texture of breast tissue.

The BI-RADS® Atlas provides standardized breast imaging findings terminology, report organization, assessment structure and a classification system for mammography, ultrasound and MRI of the breast.

The Quantra software is compatible with Hologic's 3D Mammography systems, including the new 3Dimensions mammography system, which is designed to be the fastest, highest resolution breast tomosynthesis system ever, with the 'Intelligent 2D imaging technology'.

Nearly 40% of women between the age of 40 and 74 have dense breasts, which can make it difficult to detect breast cancer during annual screenings and necessitates additional imaging, resulting in increased patient anxiety and unnecessary facility costs. Perhaps most importantly, women with very dense breasts are four to five times more likely to develop breast cancer than women with less dense breasts.

The software is one of several groundbreaking products that is available for demonstration in Hologic's booth (#4705) at the ongoing 103rd ScientificAssembly and Annual Meeting of the Radiological Society of North America (RSNA) at McCormick Place in Chicago from Nov. 26 to 30.

Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions said, "As the global leader in breast cancer screening technology, we relentlessly pursue the development of clinically superior products that address the unmet and changing needs of our customers and their patients, especially when it comes to breast density. Quantra software is yet another example of our dedication and we are proud to feature it – along with a number of other new, breakthrough products – for the world's leading radiologists at RSNA this week."

Earlier this year, FDA approved its Genius 3D Tomosynthesis Mammography as the only test superior to 2D mammography for routine breast cancer screening for women with dense breasts. 

Hologic also commercially launched its SmartcCurve breast stabilization system at the same time, that makes mammography experience less painful for women without compromising on image quality and diagnostic accuracy.

Hologic Worldwide Quantra Volumetric Breast Density Assessment

Video: From Population Based screening to Personalized Breast Care by Nancy Cappello

https://www.womenshealthmag.com

Nancy Cappello, Ph.D., executive director and founder of Are You Dense Inc. and Are You Dense Advocacy, explains how a personalized breast screening program can improve cancer detection for women with dense breasts at the 2017 AHRA annual meeting in Anaheim.

Quick facts about breast cancer in dense breast and the screening dilemma associated with it.

What is meant by “being dense”? Breast density does not correlate with physically palpated firmness of breast, it is a radiologic finding and cannot be predicted without obtaining a mammogram. 

Nearly 40% of women have dense breast. In fact, Simple screening mammography will only detect 30% cancer in dense breasts and 80% in non-dense breasts. According to the American Cancer Society, having heterogeneously or extremely dense breast tissue puts you at risk of breast cancer that is equivalent having one first-degree relative with breast cancer. (2.1 to 4 times the normal risk)

The current options available in addition to screening mammography are Tomosynthesis or 3D mammography, Ultrasound, Magnetic Resonance Imaging (MRI), Molecular Breast Imaging (MBI) or Breast Specific Gamma Imaging (BSGI) and Contrast Enhanced Spectral Mammography (CESM)

Nancy M. Cappello, Ph.D. has founded Are You Dense, Inc., and Are You Dense Advocacy, Inc., to educate women and general public about the challenges women with dense breast face regarding the screening tools for detecting early breast cancer.

FDA clears world’s first and only, non-radioactive, wire free breast tumor localizer for extended use

Cianna Medical, Inc. has received FDA clearance of the SAVI SCOUT® reflector for long term use.

The SAVI SCOUT reflector is an integral part of the SAVI SCOUT® surgical guidance system, a novel wire free technology that uses real-time audible and visual indicators for precise localization of tumor during lumpectomy and excisional biopsy procedures.

This technology is the first and only non-radioactive implant, that uses electromagnetic wave technology, with no restrictions on the length of time the reflector can remain in the breast. 

This will enable the surgeons to precisely target the affected tissue using the system’s capability of 360˚ detection and ability to pinpoint tumor location down to ±1mm, this conserves breast tissue and is more aesthetic for women at the same time increasing the surgical precision and reducing the need for repeat surgery.  

In addition, a woman with in situ SCOUT reflector can easily undergo MRI, as it does not interfere with the study.

The SCOUT reflector is 4 mm in size, and remains completely passive till it is activated by a handheld radar system. As the radar system is placed against breast, the Scout system starts sending audio-visual cues for the precise position of the reflector.  

It also eliminates the need of same day surgery and can remain in place between the time of biopsy to surgery.

Before the clearance the reflector was only allowed to stay in place for 30 days, now the time limit has been removed.

The device received its initial clearance in 2014, based on a result of small pilot study of 50 patients published later in June 2016 in the Annals of Surgical Oncology.

A larger subsequent study also by Cox et al. was published in Annals of Surgical Oncology involved 154 patients and the researchers concluded that, “SCOUT provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.”

Dr. Alice Police was the first surgeon in the country to adopt SCOUT in late 2015, at UC Irvine Medical Center, in Orange County, CA.   “My focus is always on finding a better breast cancer operation,” Dr. Police said.   “SCOUT is the standard of care for my breast localizations as I utilize this wire-free approach for all scenarios requiring localization.  The distance feature provides more control over the procedure which is important for predictable outcomes.”

Cianna Medical requires that each site and physician using SCOUT Radar Localization successfully complete training prior to initial cases. 

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News from ASRM 2017: Subfertility May be Harbinger of Disease Later in Life

The American Society for Reproductive Medicine (ASRM) 2017 Scientific Congress kicked of today morning by an opening keynote address from President Richard J. Paulson, M.D. at San Antonio, TX. The agenda ranges from the latest molecular and genetic technologies to advocacy for the patients with a focus on access to care.

Researchers from the University of Pennsylvania today presented research showing that women seeking infertility treatment have a shorter life span as compared to their parous counterparts. They have a higher risk of dying from endocrine related disorders such as diabetes and breast cancer than other women.

This retrospective cohort study examined  records of nearly 80,000 women and followed them for nearly 13 years, with an aim to determine the association of a history of infertility with all-cause mortality.

These women were enrolled in the Prostate Lung, Colorectal, and Ovarian (PLCO) Cancer screening trial from 1992-2001. Nearly 76,000 women had data on infertility.

It was seen that 14.5% (n=11,006) of women did not have any children. The average age at death for each cohort was similar (74 years) but women in infertile cohort had 10% greater chances of dying as compared to fertile cohort.  (HR1.10, 95%CI 1.03, 1.17, p=0.005).

Infertile women also face 69% increased chances of dying due to diabetes, 49% more chances of death due to breast cancer.

Ovarian cancer and Endometrial cancer did not increase the risk of death, although infertile women had marginally high risk of ovarian cancer.

This large retrospective study does show an association between endocrine related diseases and infertility but does not prove causation.It stresses the need of prospective studies and more research  in this area.

But, infertility can present an early opportunity to screen these women for chronic diseases and interventions.

Richard J. Paulson, MD, President of ASRM said in a News Release, “This is an intriguing and potentially very important study. More work is clearly needed to help us understand if, in some patients, there might be an underlying medical problem that presents as infertility during the reproductive years and then contributes to endocrine-related disease later in life. We also need to investigate if infertility treatments can counter some of this increased risk.”

The study is also published in Fertility and Sterility September supplement.