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Trial Comparing 2-D, 3-D Mammogram Outcomes

MRI of breast

MRI of breast (National Cancer Institute)

27 September 2017. A large-scale clinical trial is underway comparing the effectiveness of two-dimensional and three-dimensional mammograms in screening for breast cancer. The Tomosynthesis Mammographic Imaging Screening Trial or Tmist is enrolling 165,000 healthy women to determine if the more technologically advanced 3-D mammograms reduce the chance for women to develop advanced, life-threatening cancer than 2-D mammogram images.

Tomosynthesis mammographic imaging is a digital technique that constructs a composite 3-D image of the breast from multiple X-rays taken at different angles. The images provide a fuller picture of the breast for detecting denser tissue indicating possible cancer than conventional 2-D images taken from two angles. Both imaging techniques are approved by the Food and Drug Administration, but the trial seeks to find out if the more advanced technology is also more effective in detecting potentially dangerous breast cancer cases.

The trial is conducted by Ecog-Acrin Cancer Research Groupan organization that designs and undertakes biomarker-driven cancer research with adults who have or are at risk of developing cancer. The group formed from a merger of Eastern Cooperative Oncology Group (Ecog) and the American College of Radiology Imaging Network (Acrin), and is part of National Clinical Trials Network. National Cancer Institute, part of National Institutes of Health, is a partner in and funder of the study.

“We need to determine if 3-D mammography is better than 2-D at finding the sort of breast cancers that are most likely to spread and kill women,” says study chair Etta Pisano in an Ecog-Acrin statement. “If a newer screening technology does not reduce the numbers of advanced, life-threatening cancers, then are we really improving screening for breast cancer?” Pisano is a radiologist at Beth Israel Deaconess Medical Center and professor of radiology at Harvard Medical School in Boston.

Tmist that opened in July is recruiting 165,000 healthy women, age 45 to 74, to take part at 100 locations in the U.S. Participants, who planned to to have routine mammograms, will be randomly assigned to receive 2-D or 3-D images for 5 years. Most participants will have mammograms taken every year, although some women in lower-risk groups for developing breast cancer will have their mammograms every other year. Women taking part in the trial will then be tracked for a total of 8 years by the research team, through reviews of participants’ medical records and in some cases with follow-up phone surveys.

In addition, the researchers are asking participants to provide voluntary blood samples and mouth swabs to build a bio-repository for future studies of genetic markers associated with breast cancer. Tissue samples from biopsies, if taken, will also be collected.

The clinical trial is looking primarily at the percentage of participants diagnosed with advanced cases of breast cancer during the full study period. The study is also assessing several related factors in breast cancer diagnosis, including evaluation of breast images, agreement between local and centralized pathology reviews of biopsies, and overall health care costs covering both diagnostics and cancer care over the study period.

Ecog-Acrin says the 100 mammography sites in Tmist are geographically distributed to attract a diverse ethnic and racial mix in participants. Several Canadian mammography clinics enrolled some 3,000 participants in a similar study conducted earlier to help design Tmist.

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Algorithms ID Factors in Parkinson’s Progression

Brain circuits illustration

(HypnoArt, Pixabay)

26 September 2017. Data from two clinical trials analyzed with machine learning algorithms identify factors that predict the decline of motor functions in individuals with Parkinson’s disease. The findings, conducted by a team from the medical informatics company GNS Healthcare in Cambridge, Massachusetts, appear in yesterday’s issue of the journal The Lancet Neurology (paid subscription required).

Parkinson’s disease occurs when the brain produces less of the substance dopamine, a neurotransmitter that sends signals from one neuron or nerve cell to another. As the level of dopamine lowers, people with Parkinson’s disease become less able to control their bodily movements and emotions. Symptoms include tremors, i.e. shaking, slowness and rigidity in movements, loss of facial expression, decreased ability to control blinking and swallowing, and in some cases, depression and anxiety. According to Parkinson’s Disease Foundation, some 60,000 new cases of Parkinson’s disease are diagnosed in the U.S. each year, with more than 10 million people worldwide living with the disease.

GNS Healthcare offers a technology that applies machine learning to health care information, but with a process designed to reveal causal factors in the data, not just associations. As described by the company, that process starts by reverse engineering of data with deep-learning algorithms in large data sets from genomics, electronic health records, demographics, pharmacy and medical claims records, imaging, and mobile devices.

These algorithms yield models with potential causal factors addressing the therapy targets. GNS Healthcare then tests the models with a series of “what-if” simulations to find the optimum solutions, such as best therapies for specific individuals.

The solutions sought in this case by the team led by Jeanne Latourelle, GNS Healthcare’s director of precision medicine, seek to better predict the progression of Parkinson’s disease as it affects motor functions in patients. Not only would the findings better help prescribe more precise treatments for Parkinson’s disease patients, say the authors, but also help design clinical trials of new therapies.

Latourelle and colleagues drew data from two clinical trials of Parkinson’s disease. One study currently underway aims to uncover imaging and biologic indicators of Parkinson’s disease. From that trial’s participants, the GNS Healthcare team sampled data from 312 individuals with Parkinson’s disease and 117 healthy persons for comparison. The researchers then analyzed participants’ genetic, clinical, and demographic data against results on a standard rating scale of motor functions and quality of life for Parkinson’s disease patients.

The analysis used the company’s reverse-engineering algorithms, as well as some 5,000 simulations to identify genetic factors and biomarkers in cerebrospinal fluid, particularly in older males, that predict faster progression of Parkinson’s disease. The team validated its initial findings with an older clinical study, drawing data on 317 of its participants. Those results also show the identified factors with statistically reliable predictive power for Parkinson’s disease progression.

In addition, the findings suggest the ability to better predict the progression of Parkinson’s disease can help refine the design and recruitment of clinical trials testing new therapies. The researchers say applying results of these models can reduce variability in the results and thus reduce the size of trial samples by as much as 20 percent.

“Being able to use these predictors in the clinical setting,” says Colin Hill, GNS Healthcare CEO in a company statement, “will lead to faster and significantly cheaper clinical trials and accelerate the availability of new Parkinson’s disease drugs for patients in need.”

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Heart Scans Devised for Biometric Identification

Heart in rib cage illustration

(CIRM.gov)

26 September 2017. A computer science team designed a method for reading heart muscle contractions that uniquely identifies individuals for computer log-in and secure entry. Researchers from University at Buffalo in New York and Texas Tech University in Lubbock describe their system in a paper to be delivered next month at the ACM MobiCom 2017 conference in Snowbird, Utah.

The paper’s authors, led by Buffalo computer science and engineering professor Wenyao Xu, are seeking fast, safe, reliable, and non-obtrusive alternatives to text passwords for identifying people by their unique biological functions. Xu’s lab studies wireless electronics in health care, as well as related biometric indicators for identification. The biometric function in this case is the size and shape of the heart as it pumps blood to the body.

In their paper, Xu and colleagues note that the heart’s automatic pumping action changes the shape of the heart in ways that are not only unique to an individual, but also difficult, if not impossible, to counterfeit. Measuring heart muscle contractions electronically is hardly new; millions of electrocardiograms capture electronic signals from the heart every day. Electrocardiograms, however, use electrodes physically attached to the body around the chest cavity, wired to a reading device.

The prototype system developed by the researchers called Cardiac Scan captures much of this same information wirelessly, with a form of radar waves similar to Doppler that gauges changes in frequency caused by movement, in this case contractions of heart muscles. The device uses low-level radar signals that determine the shape and size of the heart, then record the signals as baseline measures for comparison later on. These baseline measures are unique to individuals and persistent, even when people are excited or anxious, which can alter the heart rate, but not its shape.

“No two people with identical hearts have ever been found,” says Xu in a university statement, adding that the shape of the heart remains constant, unless damaged by heart disease. Xu also notes that Cardiac Scan’s signals are weaker than Wi-Fi. “The reader is about 5 milliwatts,” says Xu, “even less than 1 percent of the radiation from our smartphones.”

The initial scan and measurement with Cardiac Scan take about 8 seconds for 4 cardiac cycles, with further scans done continuously while within range of the device. When the authorized person goes out of range from the scanner, the device automatically logs off the protected system. Cardiac Scan then logs back in when the authorized user returns within range of the scanner, without further interactions, unlike fingerprint or retinal scans. Another person who tries to use a system protected by Cardiac Scan will be denied access.

The team tested the device with 78 volunteers at Texas Tech. When the initial scans use the 4 cycles for measurement, Cardiac Scan shows an accuracy rate of 98.6 percent, which also returns the lowest error rate of 4.4 percent. The researchers conducted more tests of the device at various distances and orientations indicating that the closer the subject to the scanner, the more reliable the measure, but standing at different angles or directions to the device does not alter its ability to accurately read the heart’s geometry.

The authors carried out further tests of Cardiac Scan that show the device can read heart shapes over 2 months, and pick out the authorized user of the system when more than 1 person is within range. The team also tested the vulnerability of the device to capture and replay of initial scans, as well as spoofing counterfeit signals to access a protected device. The authors report Cardiac Scan rejects all of these attempts.

The researchers plan to conduct more tests of Cardiac Scan with individuals having irregular heart beat or wearing a pacemaker. The team also plans to miniaturize the technology for computer keyboards and smartphones.

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Geisinger, Pharmas Partner on Diabetes Model

Diabetes devices

(stevepb, Pixabay)

25 September 2017. An alliance between the Geisinger Health System and two pharmaceutical companies is developing a computer model to predict long-term health risks of patients with type 2 diabetes. Financial and intellectual property aspects of the project involving Geisinger, a health care system serving central and eastern Pennsylvania, with drug makers Eli Lilly and Company and Boehringer Ingelheim were not disclosed.

Eli Lilly in Indianapolis, and Boehringer, in Ingelheim, Germany, are already collaborating on development and commercialization of new diabetes drugs, resulting in the licensing of several Boehringer drugs by Lilly. Diabetes is a chronic disorder where the pancreas does not create enough insulin to process the sugar glucose to flow into the blood stream and cells for energy in the body. In type 2 diabetes, which accounts for some 90 percent of all diabetes cases, the pancreas produces some but not enough insulin, or the body cannot process insulin.

Diabetes often results in serious complications, particularly as patients age. The companies cite data showing people with diabetes are 2 to 4 times more likely to develop cardiovascular disease, and about two-thirds (68%) of deaths of people with type 2 diabetes are caused by cardiovascular disease. In addition, say the companies, diabetes is the leading cause of kidney failure in the U.S. The financial burden on the health care system of these complications is estimated at $23 billion per year.

The computer model is expected to enable clinicians to predict which patients with type 2 diabetes are most likely to be hospitalized with heart failure, die from cardiovascular disease, or encounter kidney failure. Geisinger is offering access to its electronic health records, with identifying information removed, to develop the algorithms in the computer model. The Geisinger data are expected to include medical history, vital signs, current medications, lab tests, and demographics.

The developers anticipate the model will make it possible to prescribe more precise treatment strategies for people with type 2 diabetes that align with guidelines for improving patient outcomes. “Our partnership,” says Geisinger epidemiologist Brent Williams in a joint statement, “will use real-world data and predictive modeling to deploy precision health care strategies to bring the most value to the people we care for. We hope the knowledge gained from this predictive model can help health care providers better target their treatment recommendations for people with type 2 diabetes and, as a result, lower their risk for these serious diabetes-related consequences.”

In January 2011, Boehringer and Lilly agreed to jointly develop and commercialize new therapies for diabetes, which in effect integrated their product current lines and new drugs still in development. The drug makers say they are also helping to raise awareness of cardiovascular complications from diabetes. Lilly, for example, has a separate web site on diabetes care.

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Infographic – Google’s Largest Acquisitions

Infographic: Google's 10 Biggest Acquisitions | Statista You will find more statistics at Statista

23 September 2017. Google and its parent company Alphabet are, of course, major players in the technology industry and a frequent topic here on Science & Enterprise. Our friends at Statista yesterday published this chart showing Google/Alphabet’s largest acquisitions over the years, including HTC’s Pixel smartphone division just this month.

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Chip Device Finds, Collects Circulating Tumor Cells

Labyrinth chip animation

(Joseph Xu, University of Michigan)

22 September 2017. A multi-disciplinary team designed a lab-on-a-chip device using hydrodynamic forces to find and help identify circulating tumor cells in blood samples. Researchers from the engineering and medical schools at University of Michigan in Ann Arbor, describe the device in the 20 September issue of the journal Cell Systems (paid subscription required).

The team from labs led by chemical engineering professor Sunitha Nagrath and cancer researcher Max Wicha who pioneered discovery of stem cells in cancer, are seeking more reliable techniques for capturing circulating tumor cells in blood. Circulating tumor cells are individual cells that break off from original tumors or those formed from where cancer spreads, and flow through the blood stream. These cells make up a minute proportion of blood volume, but are implicated in the spread of cancer to other parts of the body. Because of their tiny amounts, circulating tumor cells are difficult to find, but when detected can offer an early warning about the spread of cancer in a patient.

If reliable methods can be devised for capturing circulating tumor cells, they can offer immediate benefits to patients and clinicians, including the use of so-called liquid biopsies to detect and monitor the progress of cancer, instead of analyzing tissue samples requiring surgery from cancer patients. Nagrath, Wicha, and colleagues designed a lab-on-a-chip device using microfluidics, with tiny channels through which blood or other fluid specimens can flow, to capture these elusive cells.

The team call their device Labyrinth, since the channels in the clear plastic chip have a complex design almost resembling a maze. Doctoral candidate and first author Eric Lin who created the chip, fits 60 centimeters of channels into a 10-centimeter square design. But Labyrinth is designed to move blood samples through quickly, at 2.5 milliliters per minute, using hydrodynamics in the flow through the channels to separate and sort different types of cells.

The circular channels help separate the larger from smaller cells, with centrifugal force pushing the larger cells to the outside walls. Isolating smaller cells, however, are more of a challenge, which is the reason for sharp corners in the channel design. “Bigger cells, like most cancer cells, focus pretty fast due to the curvature, says Nagrath in a university statement. “But the smaller the cell is, the longer it takes to get focused. The corners produce a mixing action that makes the smaller white blood cells come close to the equilibrium position much faster.”

In a proof-of-concept study, the team took blood samples already drawn from 76 breast and pancreatic cancer patients participating in a clinical trial. The samples were then sent through Labyrinth, with circulating tumor cells isolated from the rest of the blood. Results show the chip provides a high yield of circulating tumor cells, more than 90 percent, and with little contamination. Additional genetic profiling of the captured cells shows tumor cells representing a wide range of stem-cell qualities, which can help design more precise treatments for patients.

“We think that this may be a way to monitor patients in clinical trials,” notes Wicha. “Rather than just counting the cells, by capturing them, we can perform molecular analysis so [we] know what we can target with treatments.”

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Gene Therapy Shown to Prevent, Reverse Multiple Sclerosis

Adeno-associated virus

Electrostatic image of adeno-associated virus (National Institute of General Medical Sciences, NIH)

22 September 2017. Medical researchers show that transferring healthy genes can protect nerve cells in lab mice against damage from multiple sclerosis, and help reverse effects of the disease. A team from University of Florida in Gainesville describe the technique in yesterday’s issue of the journal Molecular Therapy.

The researchers are led by immunologist Brad Hoffman who studies gene therapies to treat immune system disorders. Among those disorders is multiple sclerosis, an autoimmune condition where the immune system attacks the central nervous system and damages myelin, the fatty, protective substance around nerve fibers, as well as nerve cells themselves. Scar tissue from the damaged myelin, known as sclerosis, distorts the nerve signals sent to and from the brain and spinal cord, causing symptoms ranging from mild numbness to loss of vision or paralysis.

In multiple sclerosis and other autoimmune disorders, regulatory T-cells in the immune system fail to keep other immune system cells from attacking healthy tissue. The authors note that gene therapies designed to improve or correct the faulty regulation of errant immune system cells are shown to be safe when tested in patients with type 1 diabetes or graft-versus-host disease, but they so far returned temporary or limited results. Hoffman and colleagues, therefore are seeking more effective and sustained solutions, but still with gene therapy.

The Florida team chose to test a strategy of transferring healthy genes with the full sequence of myelin-producing proteins, called myelin oligodendrocyte glycoproteins or MOGs, to the liver, considered among the best environments for developing robust immune-tolerant cells. For transferring the genes, the researchers used adeno-associated viruses, benign and naturally occurring microbes that can infect cells, but do not integrate with the cell’s genome. Clinical trials cited by the authors show adeno-associated viruses are safe for humans, causing no more than mild reactions.

The researchers tested this approach in lab mice, where transferred MOGs restore immune tolerance by generating regulatory T-cells that protect against immune-system attacks against myelin surrounding nerve cells. The results show 1 injection of adeno-associated viruses transferring MOGs protect the myelin in mice for as long as 7 months.

The team also tested the transferred MOGs as a treatment in mice induced with a form of multiple sclerosis, where the gene therapy is used with rapamycin, a drug given to suppress the immune system in organ transplants. The results show transferring MOGs after giving this drug restores immune tolerance for myelin in mice with mild and moderate forms of multiple sclerosis. In some mice with paralysis in their limbs, movement in those limbs is also restored. The effects of the treatment continued until the end of of the experiments, about 100 days. Only mice with end-stage forms of the disease do not respond to the gene transfer treatments.

University of Florida applied for a patent on this technology, with Hoffman listed as its inventor.

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Expanse & Expense – The 3 Things You Need To Think About During Upscaling

– Contributed content –

Business people graphic

(Gerd Altmann, Pixabay)

22 September 2017. It’s a question that many entrepreneurs will ask themselves at some point, at what stage in the expansion of the business is it best to upscale and to physically expand your business, either to accommodate another property or to build on your existing location? It’s a veritable risk, whichever way you look at it, not just because the business expenses you once had are more than likely to go towards this second location, but the additional legwork in finding extra staff and resources can be a big strain on your current success if you let it.

Ask yourself: do you need to expand?

This is the first thing you need to ask before taking on the challenge of expanding your operation. Are you merely expanding your operation because of the demands in your current location, or has demand for your product been a recent occurrence? A lot of businesses who feel that they can expand to take advantage of growing popularity can drastically underestimate the drain on their current resources. Have you thought about the current business trends, and is this a passing thing? The important thing to think about before expanding your operation is to do a market forecast and really spend some time considering if it is the right thing to do right now.

The physical construction

If you have weighed up every factor and have decided on expanding your operation in your current location, the physical construction of the building can detract from the productivity of your workers. In this instance you need to make sure you are compartmentalizing effectively, to ensure that the construction doesn’t get in the way of your workers, and vice versa. You also need to make sure that your employees have safe access to the building, and there are companies like http://northernmat.ca/ that specialize in safety equipment such as temporary bridges and access mats, so people can get in and out of the building safely. You may also want to think about remote working capabilities for some, if not all, of your staff. And as the option to work remotely is highly desired by people who have busy lives outside of work, so this could work to your benefit by increasing productivity in the short term.

Recreating the same feel in the second location

Depending on the business you run, you may want to emulate the same feel so you can attract the same type of customers and clients. This is especially difficult if you are setting up a location far away from your current building. It can be a very difficult process to transfer the same vibe from one place to another, but the best way to do this is to make the staff the key ingredient. Have a look at https://www.forbes.com/ for an interesting article on how a small business keeps its authenticity in its brand, and how it should be part of the philosophy. Authenticity is what will keep your business operating effectively, and so you may want to move current staff to that new location or spend more time on creating a great workplace culture, one that encompasses many different locations.

The process of expanding a business in a physical sense is a major challenge, so you need to think about these three aspects before going ahead with it.

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Shanah Tovah 5778

Shofar

Shofar, a ram’s horn sounded during Jewish high holiday services (A. Kotok)

20 September 2017. Science and Enterprise is taking off tomorrow, 21 September, to observe Rosh Hashanah, the Jewish new year. We wish everyone of any faith or without, a happy and healthy new year, 5778 in our calendar. We will resume regular posting on Friday.

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Patent Awarded for Live Bacterial Acne Treatment

Acne

(Kjerstin Michaela Haraldsen, Pixabay)

20 September 2017. A company developing treatments for disease by restoring the natural balance of bacteria on the skin received a patent for its acne therapy using spray-on live bacteria. The U.S. Patent and Trademark Office awarded patent number 9,738,870 on 22 August to AOBiome LLC in Cambridge, Massachusetts. The three inventors on the patent include the two company founders, David Whitlock and Spiros Jamas, and chief medical officer Larry Weiss.

In its therapies, AOBiome seeks to reintroduce bacteria that oxidize ammonia eliminated from the skin microbiome through modern hygienic practices. Ammonia-oxidizing bacteria, says the company, convert ammonia and urea from perspiration to nitrite and nitric oxide. Nitrite helps control the growth of other microbes, including pathogens, while nitric oxide is a signaling molecule that helps regulate inflammation. The company also produces a line of skin-care products that maintain microbial balance on the skin under the brand name Mother Dirt.

Acne, known formally as acne vulgaris, is a chronic inflammatory condition that blocks hair follicles and sweat glands, primarily on the face, chest and back, affecting some 40 to 50 million people in the U.S., according to data cited by the company. AOBiome says eliminating commensal or natural bacteria from the skin also removes the nitric oxide leaving the skin as a pro-inflammatory environment.

The patent covers the technology behind AOBiome’s lead product code-named B244, a topical spray that applies ammonia-oxidizing bacteria to the skin thus restoring the natural microbial balance controlling skin inflammations such as acne. The patent covers topical applications containing live ammonia-oxidizing bacteria in a water-based medium administered as an aerosol or mist, for treating current cases of acne inflammations or as a maintenance treatment to prevent further outbreaks. The document also covers other ways of applying  the bacteria, such as in cosmetics, wipes, salves, or creams.

The company is testing B244 in an intermediate stage clinical trial with 358 adults with mild to moderate acne. In the trial, AOBiome is partnering with Science 37, a contract research company in Los Angeles that offers a remote data-gathering service known as Network Oriented Research Assistant, or Nora. The service connects clinical trial participants at their homes to Science 37, in this case to collect counts of acne lesions and other measures, with smartphones provided for the study. Previously, trial participants, or dermatology patients in general, would need to travel to doctors’ offices to evaluate progress.

As reported by Science & Enterprise in December 2016, AOBiome is also testing B244 as a treatment for hypertension. In an early-stage trial as an acne therapy, the company’s study team found a high correlation between the dose of B244 received as a facial spray and blood pressure of participants with normal blood pressure. The effect, says the company, was strong enough to reach statistically reliable levels at the highest dose. AOBiome adds that since it discovered this effect, the company engaged experts on blood pressure to verify a possible mechanism linking ammonia oxidizing bacteria on the vascular system.

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