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Trial Underway Testing Antibody for Celiac Disease

Bread loaves

(TiBine, Pixabay)

5 May 2016. A clinical trial testing an engineered antibody therapy for celiac disease in people that do not respond to a gluten-free diet began treating its first patients. The trial is conducted by Celimmune LLC, a biopharmaceutical company in in Lebanon, New Jersey, but patients are recruited in Finland, where the rate of celiac disease is among the highest in the world.

Celiac disease is an inherited immune-system disorder where people cannot tolerate gluten, a protein found in wheat, rye, barley, and some other substances. The immune reaction to gluten causes inflammation in the lining of the small intestine, which prevents absorption of nutrients. Without treatment, inflammation from celiac disease can lead to long-lasting damage in the small intestine, as well as malnutrition, since needed nutrients are not being taken into the body. About 1 percent of the U.S. population has celiac disease.

In an intermediate-stage clinical trial, Celimmune is testing its experimental treatment code-named AMG 714, an engineered antibody designed specifically to block the actions of interleukin-15, a protein produced in immune-system and intestinal cells. Interleukin-15 is associated with activating lymphocytes, white blood cells in the immune system, that destroy mucous membranes in the intestines. The company is commercializing AMG 714 under an exclusive license from the biopharmaceutical company Amgen.

Celimmune is developing AMG 714 as a treatment for people with advanced or specialized cases of celiac disease that do not respond to a gluten-free diet. The company cites data showing at least half of people with celiac disease still suffer symptoms of the disease, even when they avoid food with gluten. The condition is believed to be caused by a heightened sensitivity to gluten, which in many cases is difficult to avoid, even in trace amounts from unlikely sources such as toothpaste.

About 1 in 200 people with the condition contract refractory celiac disease or RCD-II, a complication where malignant lymphocytes are scattered throughout the small intestinal lining, causing chronic diarrhea and lymphoma. Because the cells causing the disorder are scattered through the small intestine, it is difficult to treat and often has a poor prognosis.

The clinical trial is recruiting 63 participants at 3 sites in Finland, with celiac disease and on a gluten-free diet for at least 12 months. Participants will be randomly assigned to receive either AMG 714 or a placebo, and exposed to gluten for 12 weeks. The main effectiveness measure is the change in the state of injuries in the lining of the small intestine among participants at the start of the treatments and after 12 weeks.

Researchers will also look for inflammation in the small intestine, presence of peptide or antibody biomarkers of autoimmune conditions, and other gastrointestinal symptoms. Safety and tolerability of AMG 714 treatments will be assessed as well.

Celimmune says AMG 714 was tested in 4 other trials, and found safe and well-tolerated by healthy volunteers and among people with the autoimmune disorders rheumatoid arthritis or psoriasis. A separate clinical trial is testing AMG 714 among patients with RCD-II.

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Autonomous Robot Shown Better at Soft-Tissue Surgery

Star surgical system

Smart Tissue Autonomous Robot, or Star, surgical system (Children’s National Health System)

5 May 2016. A robotic arm, programmed to work autonomously under direction of a surgeon, was shown superior at soft-tissue surgery with pigs than human surgeons and robot-assisted surgery. Results of these tests, conducted by a team from Children’s National Health System in Washington, D.C., appear in yesterday’s (4 May) issue of the journal Science Translational Medicine.

Applying the consistency and reliability of robotics to soft-tissue surgery so far eluded biomedical engineers. Soft tissue in the body includes skin, muscles, tendons, ligaments, fat, blood vessels, and nerves. The authors, led by Peter Kim, associate chief surgeon at Children’s National Health, cite data from the Centers for Disease Control and Prevention that some 44.5 million soft-tissue surgeries take place in the U.S. each year.

Robotic-assisted surgery, which requires manual control by a trained surgeon, is used today with rigid structures, such as bones, with results dependent on the surgeon’s abilities. Soft tissues, however, because of their flexible and malleable nature, are less predictable and robotics systems are not yet considered feasible for surgery.

To help fill this need, the surgical innovation institute at Children’s National Health developed its Smart Tissue Autonomous Robot, or Star, featuring a robotic arm guided by smart 3-D imaging. The arm follows near infrared sensors seeking fluorescent indicators to move around and adapt to the more complex requirements of soft tissue. Star is programmed, with algorithms and software developed by Johns Hopkins University computer scientist and co-author Simon Leonard, to operate under the supervision of a surgeon, but without the hands-on direction of current robotic-assisted surgery systems. Algorithms direct Star to follow a surgical plan, yet still make adjustments in real time as the arm adjusts to pressures and movement of the tissue.

The paper reports on common suturing procedures, known as anastomosis, performed by Star on pig tissue. Anastomosis connects tubular tissue, such as blood vessels and intestines, procedures conducted more than 1 million times a year in the U.S. While anastomosis is done frequently, it still runs risks of leakages that can run as high as 26 percent in colorectal surgery and lead to serious complications.

Kim and colleagues guided Star to perform anastomosis on intestinal tissue from pigs, first in 5 tissue samples removed from the animal, then in surgery connecting intestines of 4 live animals. Results of the procedures with Star were compared to laparoscopic — minimally-invasive “keyhole” — surgery conducted manually by trained surgeons or with a commercial robotic-assisted surgery system.

The results show Star’s suturing was equal to or surpassed the quality of hand-sutured or robotic-assisted sutures, with the system providing more consistent spacing and able to withstand higher leak pressures than the alternatives. The time needed for Star suturing was about the same as average laparoscopic procedures that run between 30 and 90 minutes.

The authors note that autonomous systems like Star are meant not to replace surgeons, but “to expand human capacity and capability through enhanced vision, dexterity, and complementary machine intelligence for improved surgical outcomes, safety, and patient access.”

Kim is founder of a start-up company Omniboros Inc. in Washington, D.C.  that develops smart automated and soft robots.

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Genomic Variations Reveal Cholesterol, Heart Disease Risks

Heart in rib cage illustration

(CIRM.gov)

4 May 2016. A review of genome and blood test records from a large group of people in Iceland identified genetic sequencing variations associated with risk factors connecting cholesterol levels to heart disease. Results of the analysis, conducted by deCode Genetics in Reykjavik, Iceland, appear this week in the journal Nature Genetics (paid subscription required).

The study, led by deCode Genetics founder and CEO Kári Stefánsson, sought to better understand connections between genetics and levels of cholesterol and fat in the blood stream, which can lead to atherosclerosis and coronary artery disease, the most common form of heart disease and leading cause of death in the U.S. Atherosclerosis, or hardening of the arteries, is a major cause of heart attacks and strokes, when plaque either breaks off or forms clots that block the arteries to the heart or brain. Plaque is made up of cholesterol and other fatty substances, as well as calcium, cellular waste and fibrin, the material that helps blood clot.

The company collects data from 160,000 volunteers in Iceland, more than half the country’s adult population. The company also amassed a genealogical database for the entire country going back 1,000 years to Iceland’s founding as an independent nation. These extensive data sets, combined with the high quality of universal health care in Iceland, says deCode, makes it possible to study most common diseases on a large scale, minimizing the selection bias that can occur in larger and more diverse populations.

The deCode technology correlates two sets of data: variations in the sequence of human genomes, and variations in phenotypes or conditions, such as a disease or physical trait. In this study, the researchers — including colleagues from institutions in Iceland, Netherlands, U.S., and Iran — looked for relationships between genomic sequencing variations and and measures of different types of cholesterol and fat in blood samples, to find those factors that best predict coronary artery disease.

The measures of cholesterol and fat levels examined in the study were high-density lipoprotein or HDL, non-HDL, low-density lipoprotein or LDL cholesterol, and triglycerides. LDL, often called “bad” cholesterol contributes to the build-up of plaque, while HDL or “good” cholesterol helps remove LDL from arteries. Triglycerides are separate type of fat that in high levels are associated with atherosclerosis.

The researchers analyzed whole genome sequencing and health records, including blood test results, from nearly 120,000 residents of Iceland. The analysis confirmed 14 sequencing variations already associated with changes in cholesterol levels, but also identified 13 rarely occurring variations in 9 other genes that were previously not known.

The team then calculated risk scores for the different cholesterol and fat measurements, and assessed the value of those scores to predict coronary artery disease with more than 33,000 people having that disorder, as well as about 236,000 individuals without heart disease for comparison. The results show non-HDL cholesterol levels, a measure of LDL and other types of cholesterol in the blood, did a better job of predicting coronary artery disease than LDL levels alone. In addition, triglyceride levels alone did not correlate with coronary artery disease risk.

“Our findings suggest that risk is best captured by measuring non-HDL cholesterol levels,” says Stefánsson in a company statement, “and this should spur an important conversation within the cardiology community to develop the most sensitive standard for testing for this risk.”

deCode Genetics is a division of the American biopharmaceutical company Amgen. As reported in Science & Enterprise, Amgen acquired deCode Genetics for $415 million in December 2012.

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Engineered Protein Advances to Treat Genetic Blood Disorders

Red blood cells with sickle cell disease

Red blood cells with sickle cell disease (NCATS.NIH.gov)

4 May 2016. Lab tests by a biotechnology company show an engineered protein can block the actions of genes responsible for low normal hemoglobin production in people with inherited blood disorders like sickle cell disease. The findings of researchers from Acetylon Pharmaceuticals Inc. in Boston were reported in April in the journal PLoS One.

Acetylon Pharmaceuticals, a spin-off enterprise from Harvard University and affiliated research institutes, develops treatments for a number of disorders using epigenetic tools that chemically influence expression of genes without changing the underlying genetic sequences. In this study, the Acetylon team led by researcher Jeff Shearstone tested an engineered protein code-named ACY-957, developed to block actions of proteins in the body known as histone deacetylases. ACY-957 is designed to inhibit specific histone deacetylases that prevent production of fetal hemoglobin, which can treat the inherited blood diseases sickle cell disease and beta-thalassemia.

Sickle cell disease is a genetic blood disorder affecting hemoglobin that delivers oxygen to cells in the body. People with sickle cell disease have hemoglobin molecules that cause blood cells to form into an atypical crescent or sickle shape. That abnormal shape causes the blood cells to break down, lose flexibility, and accumulate in tiny capillaries, leading to anemia and periodic painful episodes. Beta thalassemia is a blood disorder that reduces production of hemoglobin, causing pale skin, weakness, fatigue, and more serious complications.

Histone deacetylases interrupt normal expression and transcription of genes by modifying chromatin, the substance in cells with a nucleus that form chromosomes. But these proteins affect a wide range of functions in the body, thus limiting or blocking their actions must focus squarely on precise targets. The authors note clinical evidence that blocking histone deacetylases in general can lead to adverse and toxic reactions.

Shearstone and colleagues assessed ACY-957’s ability to limit two specific types of histone deacetylases or HDACs shown previously to affect production of fetal hemoglobin in red blood progenitor cells that transform into adult red blood cells. The team tested ACY-957 in the lab with blood samples from people with sickle cell disease, and for comparison healthy individuals. The results of gene expression profiles show ACY-957 blocked the actions of the two suspect histone deacetylases, and induced more production of fetal hemoglobin in the red blood progenitor cells.

The Acetylon team also identified mechanisms that brought on these results. The gene profiles showed as well a 3-fold increase in expression of the GATA2 gene that produces a protein binding to other genes that encourage production of blood cells. The increased GATA2 yield, say the authors, results in more intermediate proteins that promote production of fetal hemoglobin.

“These new data will inform the design of future programs at Acetylon,” says Matthew Jarpe vice president  of biology in a company statement. Jarpe was senior author of the PLoS One paper.

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Patent Granted for RNA Transcription Technology

Jeannie Lee

Jeannie Lee (RaNA Therapeutics)

3 May 2016. A technology that blocks RNA molecules from activating chemicals in the body suppressing the working of genes to treat or prevent disease received a U.S. patent. The Patent and Trademark Office awarded patent number 9,328,346 to five inventors and assigned the patent to the parent company of Massachusetts General Hospital in Boston. The technology was licensed to RaNA Therapeutics in Cambridge, Massachusetts, co-founded by lead inventor Jeannie Lee, a professor of genetics and pathology at Mass. General and Harvard Medical School.

Lee and colleagues study regulation of long non-coding RNA in epigenetics, influences on genetic activity occurring outside the genome. RaNA Therapeutics develops therapies from oligonucleotides, small pieces of nucleic acids that in the company’s technology target specific regions of ribonucleic acid, or RNA that carries instructions from DNA in an individual’s genes to cells in the body.

RaNA Therapeutics aims its oligonucleotides at long non-coding RNA molecules attracting proteins that can modify chromatin in cells. Chromatin forms chromosomes in cells with a nucleus. This interaction of long non-coding RNA and chromatin modifiers, says the company, can suppress the normal expression of genes, thus stopping this interaction activates the gene’s expression and transcription.

The patent covers the targeting of long non-coding RNAs, as well as other nucleic acids that regulate gene expression, and methods for their use. In this case, long coding RNAs bind to chromatin modifiers in the polycomb repressive complex 2 family of proteins. These proteins are associated with the creation and maintenance of repressive chromatin environments.

RaNA Therapeutics says its technology can be applied to a variety of diseases, with the initial focus on disorders where genes’ expression of proteins in higher than normal levels is beneficial. The first therapies under development are treatments for the rare central nervous system disorders spinal muscular atrophy, caused by a loss of motor neurons in the spinal cord and brain, and Friedreich’s ataxia, an inherited disease causing damage to the nervous system and movement problems. Both programs are still in preclinical stages.

Inventor Jeannie Lee’s work with long non-coding RNA in epigenetics was recognized in her receiving this year’s Lurie Prize in biomedical sciences. The prize of $100,000 is awarded for outstanding achievement by a promising young scientist in biomedical research, by the Foundation for the National Institutes of Health. The award was announced in mid-February.

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Lung Function App Service Expanded to Any Phone

Cell phone with SpiroCall message

SpiroCall provides spirometry tests with early cell phones and landlines. (University of Washington)

3 May 2016. A computer science lab extended the abilities of its smartphone app that measures lung function to a call-in service for any phone in the world. The team led by engineering and computer science professor Shwetak Patel at University of Washington will discuss the new service at the ACM Computer-Human Interaction (CHI) 2016 conference that begins on 7 May in San Jose, California.

Patel’s UbiComp lab in Seattle developed in 2012 a smartphone app known as SpiroSmart that measures the flow rate and volume of lungs when inhaling and exhaling, functions usually tested with a spinometry instrument in a clinic and some home devices. Spinometers are used to diagnose lung diseases, such as asthma and chronic obstructive pulmonary disease, or COPD, as well as monitor lung functions over time in people with these disorders.

As reported in Science & Enterprise, Patel’s team built the SpiroSmart app to capture sound waves from a person blowing into the smartphone’s microphone. The app uploads the recorded sound file to a server, where a model of a human trachea and vocal tract is used to analyze the sound waves. Software on the server then detects breathing irregularities, with a report sent back to the app. Since 2012, Patel and colleagues tested SpiroSmart with more than 4,000 individuals, and clinical trials of the app are underway in the U.S., India, and Bangladesh.

While the SpiroSmart app makes it possible to expand spirometry to more people than before, the smartphone requirement still leaves out many individuals in low-resource regions or those without smartphones. To fill those gaps, the lab devised a call-in service known as SpiroCall that allows individuals to measure their lung functioning with regular voice telephone lines and early cell phone models. Reports are then sent back as text messages to phones on cellular networks.

SpiroCall had to overcome lower audio quality when a person breaths into a telephone handset or cell phone, then carried over voice telephone line or cellular frequency. To meet this challenge, the UbiComp team of Patel and doctoral students Mayank Goel and Elliot Saba rewrote its analytical algorithms, first breaking down the breathing flow rate signals, then calculating the regression lines into a single median estimate of lung functioning.

The researchers also encountered wide variation in types of telephones and the distance between the caller’s mouth and handset that influenced audio quality. In addition, people with severe lung problems could not generate breathing sounds loud enough to be captured consistently by the call-in system. To overcome these problems, the team designed a simple plastic whistle, which they produced on a 3-D printer, modeled after a similar whistle created in 1954 that changes pitch when breathing flow rates change.

Patel and colleagues recruited 50 volunteers to test SpiroCall, of which 16 had asthma or other lung conditions. The test recorded and analyzed lung functions with voice telephone calls on smartphones, earlier-model cellphones, and landline handsets. The calls were captured on voicemail, then uploaded to the SpiroCall server. The volunteers also tested the system with and without the plastic whistle, and took measurements of their lung functions with clinical spirometers.

The results show lung function measurements made with SpiroCall, both with and without the plastic whistle, varied on average 6.2 percent from clinical spirometers, within standard margins of error for those devices. Using the whistle, however, reduced the number of false positive readings and made the estimation models easier to generalize across different types of phones.

In the following video, Goel and Saba tell more about SpiroCall.

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Drug Pricing Reform Even Big Pharma Might Like

Pills and dollar bill

(TBIT/Pixabay)

2 May 2016. At a press event in Washington, D.C. last week, Representative Lloyd Doggett of Texas, a champion of lower prescription drug prices, took aim at drug companies and their business practices. “An unaffordable drug is 100 percent ineffective,” Doggett told an audience at Center for American Progress on 26 April. He noted that 9 out of 10 drug makers spend more on marketing than R&D, with Americans spending 12 times more on drugs than people in Ireland, where some American drug companies are trying to escape for lower corporate tax rates.

Doggett, a senior Democrat on the House Ways and Means Committee, was keynote speaker at a panel discussion of a report from Center for American Progress, a progressive think tank in Washington, D.C. Like Doggett, CAP’s report — titled Enough is Enough — called for action by Congress and the executive branch to bring more transparency to drug pricing, and to create pricing models based more on value to the patient than maximizing revenues to the drug companies.  The federal government, said CAP’s report and a panel of experts to discuss its findings, can play a larger role in bringing down drug prices, from exercising its buying power through Medicare and Medicaid, as well as leveraging its support for basic life sciences research.

The pharmaceutical industry in the U.S. has a long track record of successfully heading off actions by governments, either by cutting advantageous deals or through lobbying. But calls for doing something meaningful about escalating drug prices are getting louder and angrier, with the industry now left largely alone to fight its legislative battles. And new technologies could make the industries current economic model as outmoded as Life magazine and the Sears catalog.

High prices causing unfilled prescriptions

The panel, chaired by Ezekiel Emanuel, vice-provost at University of Pennsylvania and long-time proponent of health care reform, included Marilyn Tavenner, CEO of America’s Health Insurance Plans, Debra Whitman, chief public policy officer at AARP, and Joshua Ofman, vice-president for for global value, access, and policy at biopharmaceutical company Amgen. Tavenner joined the health insurance industry group in July 2015 after serving in 2013-14 as Administrator of Centers for Medicare and Medicaid Services, in the U.S. Department of Health and Human Services.

The entire panel, including Amgen’s Ofman, the sole industry representative, agreed high drug prices were a problem and cause for concern. Whitman cited recent surveys by AARP of Americans age 50 and over showing more and more difficulty paying for prescription drugs, including 1 in 3 respondents who did not fill a prescription mainly because of its cost. In addition, three-quarters (76%) of American seniors want government to do more to bring down drug prices, about the same percentage of Americans overall cited in CAP’s report that say drug prices are too high.

The panel discussed several proposals in the CAP report and elsewhere to bring more transparency to drug prices, employ comparative effectiveness research to assess the relative value of different treatments, encourage bulk-sale negotiations with government and large insurers, apply success-based outcome models to justify higher prices for drugs, and limit out-of-pocket cost-sharing in health insurance plans. Other ideas included limits on patent lifetimes and bans on pay-for-delay schemes where drug companies pay makers of generic drugs to delay issuing substitutes with lower prices.

Liberal policy wonks at think tanks aren’t the only people pushing these proposals. Many of these same ideas were expressed in an article signed by 118 cancer specialists in July 2015 in the journal Mayo Clinic Proceedings, and in March 2016 by the American College of Physicians in an article in Annals in Internal Medicine. These statements suggest large segments of the physician community aren’t buying the industry’s arguments.

Amgen’s Ofman pushed back on many of these proposals, noting that the costs for developing new drugs are high because the nature of disease is difficult and complex, with Amgen itself spending $4 billion a year on R&D. Thus measuring the value of drugs is also difficult and complex, particularly when bringing in the needs of special populations, like the disabled or children. Applying a single value formula to drug prices, said Ofman, becomes in effect a cost-control, which would have serious market repercussions.

In addition, Ofman pointed out negotiations by insurance plans can bring down costs for some customers, but hospitals still charge full price for non-insured patients. Moreover, Ofman argued, value should be calculated over  the drug’s lifetime, including its generic period. Ofman’s arguments resulted in the other panel members accepting, at least in principle, that the issue does not lend itself to easy answers.

Continue reading Drug Pricing Reform Even Big Pharma Might Like

Challenge Seeks New Regenerative Tools with Stem Cells

Induced pluripotent stem cells

Induced pluripotent stem cells reprogrammed from human skin (California Institute for Regenerative Medicine)

29 April 2016. A challenge offered through InnoCentive is seeking new methods of harnessing adult stem cells for regenerative medicine. The competition has a total purse of $15,000 and a 24 June 2016 deadline for submissions. The sponsor of the challenge, pharmaceutical company Boehringer Ingelheim, also seeks research plans related to the challenge proposals, with funding amounts negotiated separately.

The competition is conducted by InnoCentive in Waltham, Massachusetts that conducts open-innovation, crowdsourcing competitions for corporate and organization sponsors. Free registration is required to see details of the competition. In November 2015, Boehringer Ingelheim revealed that it plans to make more use of crowdsourcing for R&D ideas through InnoCentive and others.

From the competition, Boehringer Ingelheim hopes to uncover new processes that further the promise of endogenous, or adult, stem cells for regenerative medicine. Adult stem cells are those inhabiting human tissue, as opposed to embryonic stem cells that can transform into any cells in the body. Adult stem cells, however, may be more readily available with patients, and do not carry the ethical baggage of embryonic stem cells with some people.

Adult stem cells maintain and repair the tissue in which they reside, and like embryonic stem cells transform or differentiate into some or all of their representative tissue cells. Current methods for differentiating adult stem cells into functioning tissue cells, in most cases, first require genetically reprogramming stem cells into a state similar to embryonic cells. These induced pluripotent stem cells are already proving to be valuable tools in drug development, and eventually for transplantation.

Boehringer Ingelheim is seeking new molecular mechanisms and processes for collecting, stimulating, and differentiating adult stem cells for regenerative cell-replacement therapies. The solutions should address, direct, or enhance the built-in capabilities of adult stem cells to maintain human tissue.

InnoCentive calls this type of competition an ideation challenge, which requires a brief (two-page) proposal. Ideation proposals can contain ideas originating from the participants, the public domain where no restrictions are applied, or third-parties where participants have the rights to propose solutions with those ideas. Participants are asked not to submit confidential information in their proposals.

Boehringer Ingelheim says it plans to award the entire $15,000 challenge purse, with at least one award being no smaller than $5,000 and no award being smaller than $1,000. The sponsor also indicates that submitting a proposal grants the sponsor a non-exclusive, perpetual, and royalty-free license to use any information in the proposal. An exclusive transfer of intellectual property rights to the sponsor, however, is not required.

Participants in the competition with their own research facilities can apply for funding to carry out the research plan in their challenge proposals. Boehringer Ingelheim says delivery schedules and funding amounts for these research plans will be negotiated separately from the challenge awards. The company says the optional research proposals will also be considered separately from the challenge submissions, but still have a 24 June 2016 deadline.

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University Lab Spins-Off Fertility Testing Company

Katie Brenner in lab

Katie Brenner (Bryce Richter, Univ. of Wisconsin-Madison)

29 April 2016. A new company is taking shape that aims to make it easier for women to get pregnant, based on research at a biochemistry lab at University of Wisconsin. BluDiagnostics, in Madison, founded by postdoctoral research Katie Brenner in the lab of biochemistry professor Douglas Weibel, a co-founder of the company, already raised $1.2 million in seed funding.

Brenner’s interest in the topic is more than academic. In her own experiences to start a family, Brenner discovered the difficulty and unreliability of finding the optimal ovulation time that today uses a combination of urine and blood tests to measure levels of hormone indicators. “We looked at how many women struggle to become pregnant,” says Brenner in a university statement, “and they don’t know if it’s something about their body, their partner’s body, or just poor timing. It’s hard to find information at a time when you want a lot of information and control.”

At Wisconsin, Brenner applies her bioengineering doctorate to practical microbiology issues. In this case, she and Weibel devised a process where women wet a paper strip with saliva, a more readily available bodily fluid than blood or urine. The paper strip is infused with reagents that test for the hormones progesterone and estrogen, where changes in levels are indicators of ovulation.

Hormone level measurements from the paper strip are sent to a smartphone app called Fertility Finder that records the readings and tracks the daily measurements over time. Brenner adds that “nobody wants to take a blood test every day, so we developed one using saliva instead.” She and Weibel filed a patent application for their technology.

BluDiagnostics started officially in 2012 with life sciences business consultant Jodi Schroll joining Brenner and Weibel as co-founder, but real activity with the company began only last year. In the space of three months, June through August 2015, BluDiagnostics won three business contests in Wisconsin, including the Governor’s Business Plan Competition. These wins helped the company attract loans of $1.2 million as seed funding in January and February of 2016.

BluDiagnostics aims to gain FDA approval for its device, and reach the market in 2017. Brenner believes its basic technology can be extended to improve reporting on other women’s health issues. “Most studies collect self-reported data on menstrual cycles: what you ate, your mood and exercise, and try to reach medical conclusions,” she notes. “For the first time, we will marry that data with cold, hard numbers to support a better understanding of relationships between hormonal trends and underlying disorders.”

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Collaboration Explores Humanitarian Satellite Applications

Microsatellites before launch

Microsatellite nodes in lab before launch (NASA)

28 April 2016. A start-up satellite imaging provider and agency of the United Nations are partnering on new ways to use satellite imaging to further the UN’s humanitarian, peace-keeping, and climate change mitigation missions. Financial terms between BlackSky Global LLC in Seattle and the United Nations Institute for Training and Research, or Unitar, were not disclosed.

BlackSky Global, founded in 2013 and that began operations in June 2015, is offering high-resolution satellite imaging on a fee-for-image model, which the company says will deliver images faster and at a fraction of the cost of current providers. The company plans to launch 6 satellites this year, with its full fleet of 60 satellites in orbit by 2019, which will enable BlackSky to provide a 30-square kilometer image for less than $100, about one-tenth of the current industry average, in 2 hours or less.

In their agreement, BlackSky and Unitar will jointly explore and develop new applications for satellite imagery that support the UN’s work in humanitarian relief and sustainable development. A division of Unitar known as Unosat already provides services with geographic information systems and satellite imagery for UN agencies and member states, as well as other international agencies and non-government organizations.

Unitar and Unosat are particularly interested in BlackSky’s professed ability to deliver images with a resolution of 1 square meter and fast turn-around. “The combination of detailed 1 meter resolution imagery with frequent revisit times and near real-time delivery,” says Unosat manager Einar Bjorgo in a Unitar statement, “will open new applications areas and further strengthen existing services we provide to the UN family and developing countries.”

Unitar and BlackSky plan to explore applications for the company’s satellite services to support the UN’s work in humanitarian relief and early recovery, peace-keeping missions, climate change adaptation, disaster risk reduction, cultural heritage protection, environmental monitoring, and sustainable development.

To compete with current providers of high-resolution satellite images, BlackSky plans to launch a fleet of microsatellites, mainly in mid-latitudes, that provide frequent revisiting rates over 95 percent of the world’s population. Those satellites will provide still images and 1-frame-per-second video, supported by a software program for customers to request and receive images via the Internet.

The company expects to launch its first 6 satellites by the end of 2016, with commercial services starting in 2017. BlackSky is an independent subsidiary of Spaceflight Industries. The company says it raised $28.5 in financing over the past 2 years, and has 20 employees.

Following is an example of Unosat images currently provided, in this case showing damage from the recent earthquake in Ecuador.

Ecuador earthquake damage report

Satellite-detected damaged structures in Chone area in Manabi Province, Ecuador, located about 175 km south west of the 16 April 2016 Muisne earthquake main shock epicenter. Click on image for full-size display. (Unosat)

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