Latest addition to growing portfolio of breast and skeletal health innovations to be featured at ECR 2019

Hologic, Inc. (Nasdaq: HOLX) today announced the granting of a CE Mark to the LOCalizer™ wireless radio frequency identification (RFID) breast lesion localization system. This system is designed for precise and easy marking and targeting of lesions for breast-conserving surgery guidance.
The system is one of many in Hologic’s expanding suite of breast and skeletal health products, including screening, interventional, ultrasound and surgical solutions, that will be available for demonstration in Booths X2 – 211 and X5 – 521 at the annual European Congress of Radiology (ECR) meeting in Vienna, Austria from Feb. 27 to March 3.
The LOCalizer tag is designed to replace the traditional wire-guided localization method, helping to provide increased comfort and convenience for patients and their healthcare teams. The tag can be implanted up to 30 days prior to a breast-conserving surgery, providing increased flexibility for patients and providers. This improved workflow is designed to help reduce scheduling and logistical hurdles for care teams and aims to deliver added convenience for an enhanced patient experience. Following placement, the miniature implantable tag can be detected by a portable, handheld reader that indicates the location and distance in millimeters to the lesion, enabling the surgeon to pinpoint the correct area of breast tissue for removal.
“We look forward to showcasing the new LOCalizer system at ECR as we continue to broaden our offerings to make a positive impact on breast health at every step of the patient journey – from screening to pathology,” said Jan Verstreken, Regional President EMEA and Canada, Hologic. “This thoughtful expansion is rooted in our commitment to developing new and innovative solutions clinically proven to improve cancer detection, patient satisfaction and facility workflow, while reducing costs associated with unnecessary callbacks.”
The market leader behind the 3D Mammography™ exam, Hologic has expanded significantly in recent years through insight-driven innovation and strategic acquisitions to address the entire clinical continuum of breast health. Along with the LOCalizer system, the Company’s new products include the SmartCurve™ breast stabilization system, Clarity HD high-resolution 3D™ imaging technology, the Viera™ portable breast ultrasound system, and the Brevera^® breast biopsy system with CorLumina® imaging technology, which features real-time imaging and sample verification. Two recent acquisitions of Faxitron^® Bioptics, a leader in digital specimen radiography, and Focal Therapeutics, manufacturer of the BioZorb^® marker, have enabled Hologic to play a larger role in breast-conserving surgery and strengthened its offerings to radiologists, pathologists and breast surgeons.
Visitors to the Hologic booth at ECR can experience the A.I. Future Suite, highlighting Hologic’s long-standing commitment to incorporating artificial intelligence and machine learning into its groundbreaking technologies. Attendees will have a chance to experience current and future applications of A.I. in breast imaging, and learn more about how Hologic plans to continue to deliver significant value as a leader in the space. In addition, the Company’s entire suite of breast and skeletal health products, such as the 3Dimensions™ Mammography System and Fluoroscan^® Insight™ FD Mini C-Arm, will be on display and available for demonstration.
Throughout ECR, Hologic will host a variety of workshops and a symposium, Advances in Breast Imaging: Clinical use of CEDM across Europe. Workshop topics will offer hands-on experience and expert insight into topics including: clinical workflow using tomosynthesis guidance and real-time breast biopsy imaging; a new technique for breast lesion localization; wireless ultrasound guided biopsies; contrast-enhanced mammography in clinical practice; optimization of tomosynthesis reading time; and breast density case reviews. For more information, please visit ecr.Hologic.com or visit Hologic’s Booths X2-211 and X5-521.
The LOCalizer system is manufactured by Health Beacons, Inc. and is exclusively distributed by Hologic.

Five percent more cardiac infarctions detected and 11 percent fewer patients suffering a relapse. That is the result of a study of more than 80,000 patients in which two cardiac damage markers (conventional troponin and the newer, high-sensitive troponin T) were compared with each other.
“This can serve to motivate hospitals that have not yet adopted the high-sensitive troponin T. It is more sensitive, and a heart attack can be identified earlier,” says Maria Odqvist, a doctoral student at the Institute of Medicine at Sahlgrenska Academy and the lead author of the study “It’s also possible to determine if the problem is not a heart attack and where the patient’s chest pain is due to something else.”
The study, which is a collaboration with Karolinska Institutet, encompasses all patients who suffered heart attacks in Sweden during the 2009–2013 period. A total of 87,879 people were studied, of which 40,746 were diagnosed using high-sensitive troponin T and 47,133 were tested using conventional troponin. The groups were similar in terms of gender and age distribution and other types of illness in the patients’ history.
Similar studies have been carried out before but then on selected groups of patients, which were treated primarily in cardiac intensive care departments. This study also included patients treated in other departments to collect a broader range of cases.
Chest pain is one of the most common reasons people seek emergency medical care. To determine if a person has suffered a cardiac infarction, symptoms are assessed partly on the basis of chest pain and partly with an electrocardiogram taken to detect typical changes consistent with a heart attack.
In addition, a blood test is taken to measure levels of the protein troponin or else high-sensitive troponin T, both of which are biomarkers for heart damage. Elevated troponin values indicate that cells in parts of the heart have died from lack of oxygen after a heart attack impeded the flow of blood.
The current study showed that the more sensitive marker, troponin T, detected five percent more heart attacks, although with no impact on survival. On the other hand, the number of heart attack victims suffering a relapse was 11 percent lower in that group.
When high-sensitive troponin T started being introduced in 2009, there was concern about spending of health care resources in general and that interventions and treatments for the group of patients with suspected heart attacks would increase.
"We could see a small increase in the number of coronary angiography and balloon blasts, which are associated with finding more cardiac infractions, but the increase is quite modest”, says Maria Odqvist.

University of Gothenburgwww.gu.se/english/about_the_university/news-calendar/News_detail//increased-safety-in-diagnosing-cardiac-infarction-with-more-sensitive-analytical-method.cid1571664

EXPLORER, the world’s first medical imaging scanner that can capture a 3D picture of the whole human body at once, has produced its first scans.
The brainchild of UC Davis scientists Simon Cherry and Ramsey Badawi, EXPLORER is a combined positron emission tomography (PET) and X-ray computed tomography (CT) scanner that can image the entire body at the same time. Because the machine captures radiation far more efficiently than other scanners, EXPLORER can produce an image in as little as 1 second and, over time, produce movies that can track specially tagged drugs as they move around the entire body.
The developers expect the technology will have countless applications, from improving diagnostics to tracking disease progression to researching new drug therapies.
The scanner has been developed in partnership with Shanghai-based United Imaging Healthcare (UIH), which built the system based on its latest technology platform and will eventually manufacture the devices for the broader health care market.
“While I had imagined what the images would look like for years, nothing prepared me for the incredible detail we could see on that first scan,” said Cherry, distinguished professor in the UC Davis Department of Biomedical Engineering. “While there is still a lot of careful analysis to do, I think we already know that EXPLORER is delivering roughly what we had promised.
Badawi, chief of nuclear medicine at UC Davis Health and vice chair for research in the Department of Radiology, said he was dumbfounded when he saw the first images, which were acquired in collaboration with UIH and the Department of Nuclear Medicine at the Zhongshan Hospital in Shanghai.
“The level of detail was astonishing, especially once we got the reconstruction method a bit more optimized,” he said. “We could see features that you just don’t see on regular PET scans. And the dynamic sequence showing the radiotracer moving around the body in three dimensions over time was, frankly, mind-blowing. There is no other device that can obtain data like this in humans, so this is truly novel.”
Badawi and Cherry first conceptualized a total-body scanner 13 years ago. Their idea was kickstarted in 2011 with a $1.5 million grant from the National Cancer Institute, which allowed them to establish a wide-ranging consortium of researchers and other collaborators. And it got a giant boost in 2015 with a $15.5 million grant from the National Institutes of Health. The funding allowed them to team up with a commercial partner and get the first EXPLORER scanner built.
Cherry said he expects EXPLORER will have a profound impact on clinical research and patient care because it produces higher-quality diagnostic PET scans than have ever been possible. EXPLORER also scans up to 40 times faster than current PET scans and can produce a diagnostic scan of the whole body in as little as 20 to 30 seconds.
Alternatively, EXPLORER can scan with a radiation dose up to 40 times less than a current PET scan, opening new avenues of research and making it feasible to conduct many repeated studies in an individual, or dramatically reduce the dose in paediatric studies, where controlling cumulative radiation dose is particularly important.

UC Davis
www.ucdavis.edu/news/human-images-worlds-first-total-body-scanner-unveiled

When a patient arrives in any emergency department, one of the first steps in their care process is triage, an opportunity for a care team member to identify critically ill patients and assign priority treatment levels.
“With increases in annual visits to U.S. emergency departments, declines in capacity have led to unprecedented levels of crowding and consequential delays in care,” says Scott Levin, Ph.D., associate professor of emergency medicine at the Johns Hopkins University School of Medicine. “So what emergency departments have to do is very quickly assess whether a patient is in need of real critical, time-sensitive treatment versus a patient who is safe to wait.”
Across the country, nurses and physicians typically use the emergency severity index (ESI) during triage to assign a score from Level 1 for patients who are the most critically sick, to Level 5 for patients who are the least sick. A patient’s ESI level determines in which area of the emergency department that patient will be seen, places the patient in a queue and influences provider decision-making throughout the patient’s care process. “This algorithm is completely subjective,” Levin says. “Nurses and physicians make a quick assessment on whether the patient can wait solely based on their clinical judgment.” In most cases, researchers say patients are assigned to a Level 3 and not entirely differentiated. “We thought that Level 3 patient group included a large mix of patients who are pretty sick and others who weren’t, and our goal was to determine whether these patients could be sorted out,” Levin says.
To help differentiate patient triage levels, Levin and a team in the Department of Emergency Medicine developed an electronic triage tool. In a recently published paper the e-triage tool showed equal or improved identification of patient outcomes compared to ESI based on a multi-site retrospective study of nearly 173,000 emergency department visits. The study showed significant differences in patient priority levels using e-triage and ESI. For example, out of the more than 65 percent of visits triaged to ESI Level 3, e-triage identified about 10 percent, or more than 14,000, ESI Level 3 patients who may have benefitted from being up-triaged to a more critical priority level, such as Level 1 or 2. These patients were at least five times more likely to experience a critical outcome, such as death, admission to the ICU or emergency surgery, and two times more likely to be admitted to the hospital. The e-triage tool was also able to increase the number of patients down-triaged to a lower priority level, such as Level 4 or 5, to help minimize low-acuity patients from waiting and overusing scarce resources.
The e-triage tool uses an algorithm to predict patient outcomes based on a systems engineering approach and advanced machine learning methods to identify relationships between predictive data and patient outcomes. “When a patient comes in, and we collect the patient’s information, the e-triage tool is comparing that patient to hundreds of other like patients to make a prediction on the patient’s outcome,” Levin says.
These methods are common in other industries, such as defence, transportation and finance, but rarely, if ever, are implemented in healthcare. “Machine-based learning takes full advantage of electronic health records and allows a precision of outcomes not previously realizable,” says Gabor Kelen, M.D., director of the Department of Emergency Medicine and professor of emergency medicine at the Johns Hopkins University School of Medicine. “It is the wave of future healthcare, although some providers may be hesitant. Decision aids that take advantage of machine-learning are also highly customizable to meet the needs of an emergency department’s patient population and local healthcare delivery systems.”
The e-triage tool is also designed to be a decision support tool to help clinicians make better care decisions about their patients. “The theory behind this tool, and all clinical decision support tools, is that the tool paired with the clinician can make better predictions or better prognostics tasks like this than the tool alone or the clinician alone,” Levin says.
Better differentiating patients’ priority levels, can, in turn, help patients get the appropriate care they need. “The ultimate objective is patients should be waiting less in the emergency department,” Levin says. “For patients at risk of having a critical care need, this technology is designed to detect them better and make sure they are seen quicker. For patients who are less sick, e-triage should detect those patients and put them on an expedited track, so they don’t need to wait as long.”

John Hopkins Medicinehttps://tinyurl.com/y7whserq