An anonymous reader writes: 2016 has not started well for blood-testing startup Theranos. Already facing allegations of data manipulation, the Centers for Medicare and Medicaid Services have found problems with Theranos' laboratory in Newark, California, putting the company's relationship with the Medicare program in danger. WSJ reports: "It isn't clear exactly what regulators have faulted Theranos for in their latest inspection, which took several months. Adverse findings would be another regulatory setback for one of Silicon Valley's highest-profile startups, valued at about $9 billion in 2014. Theranos already has stopped collecting tiny samples of blood from patients' fingers for all but one of its tests while it waits for the Food and Drug Administration to review the company's applications for wider use of the proprietary vials called 'nanotainers.' In October, the FDA said it had determined that the nanotainers were an 'uncleared medical device.'"

An anonymous reader writes: Three science papers that had suggested that genetically modified crops were harmful to animals and have been used by activist groups to argue for their ban have been found to contain manipulated and possibly falsified data. Nature reports: "Papers that describe harmful effects to animals fed genetically modified (GM) crops are under scrutiny for alleged data manipulation. The leaked findings of an ongoing investigation at the University of Naples in Italy suggest that images in the papers may have been intentionally altered. The leader of the lab that carried out the work there says that there is no substance to this claim. The papers' findings run counter to those of numerous safety tests carried out by food and drug agencies around the world, which indicate that there are no dangers associated with eating GM food. But the work has been widely cited on anti-GM websites — and results of the experiments that the papers describe were referenced in an Italian Senate hearing last July on whether the country should allow cultivation of safety-approved GM crops. 'The case is very important also because these papers have been used politically in the debate on GM crops,' says Italian senator Elena Cattaneo, a neuroscientist at the University of Milan whose concerns about the work triggered the investigation.

An anonymous reader writes: Silicon-based electronic circuits that operate flawlessly in the body for some number of days--soon weeks--and then harmlessly dissolve: they're what University of Illinois professor John Rogers says is the next frontier of electronics. Today he released news of successful animal tests on such transient electronics designed for use in brain implants, but says they could be used just about anywhere in the body. As these devices move into larger animal and eventually human tests, Rogers says he'll be working on the next generation--devices that intervene to accelerate healing or manage medical conditions, not just monitor them.

Zane C. writes: The 100,000 Genomes project, an organization dedicated to diagnosing and researching rare genetic disorders, has just diagnosed its first 2 patients. After painstakingly analyzing about 3 billion base pairs from the parents of one young girl, and the girl herself, "doctors told them the genetic abnormality — in a gene called KDM5b — had been identified". The new information will not yet change the way the young girl, named Georgia, is treated, but it opens up a path for future treatments. For the other girl, Jessica, the genetic analysis provided enough information to diagnose and begin a new treatment. A mutation had occurred "[causing] a condition called Glut1 deficiency syndrome in which the brain cannot get enough energy to function properly." Jessica's brain specifically had not been able to obtain enough sugar to power her brain cells, and as such, doctors prescribed a high fat diet to give her brain an alternate energy source. She has already begun showing improvement.

hypnosec writes: In a first kind of discovery in decades, researchers have created a new class of hybrid sound waves that are gentle enough to be used in biomedical devices. Known as "surface reflected bulk waves", the new class of sound waves are a hybrid of bulk waves and surface waves and have been created by a team at RMIT University in Melbourne, Australia. According to the team the new class of sound waves have already proved their worth in delivering vaccines and other drugs directly to the lung and are hopeful that their creation could lead to a revolution in stem cell therapy. As Dr Amgad Rezk, from RMIT's Micro/Nano Research Laboratory, explains, they have already dramatically improved the efficiency of an innovative new "nebuliser" that could deliver vaccines and other drugs directly to the lung in as little as 30 seconds [study abstract]. Researchers are hopeful that their work opens up the possibility of using stem cells more efficiently for treating lung disease enabling them to nebulise stem cells straight into a specific site within the lung to repair damaged tissue and this could be a real game changer for stem cell treatment in lungs as well as other organs.

Press2ToContinue writes: A German carpenter has invented a valve which he claims will revolutionize contraception, by allowing a man to turn the flow of sperm from his testicles on and off at the flick of a switch. It (the switch, of course) is nearly an inch long and weighs less than a tenth of an ounce. It is surgically implanted on the vas deferens, the tube that carries sperm from the testicles, in a half-hour operation, and controlled by a switch beneath the skin of the scrotum.

So far Bimek is the only man who has the switches implanted, one for each testicle. I wonder what other switches we will see implanted into humans in the future? I think I'd like a valve for adrenaline control.

the_newsbeagle writes: Now that it's easy and cheap to build strands of DNA, what kinds of strange new organisms will scientists and start-ups build? That's the question raised as synthetic biology companies like Twist Bioscience and Zymergen start up their DNA manufacturing lines. Researchers who order DNA snippets typically pay on a cost-per-nucleobase basis. These companies say their mass-production techniques could bring prices down to 2 cents per base, which would allow researchers to scale up experiments and learn through trial and error.

schwit1 writes with news that scientists have used a new gene-editing technique called CRISPR to treat mice with defective dystrophin genes. This is the first time that such a method has successfully treated a genetic disease inside a living mammal. The Times reports: "Three research groups, working independently of one another, reported in the journal Science that they had used the Crispr-Cas9 technique to treat mice with a defective dystrophin gene. Each group loaded the DNA-cutting system onto a virus that infected the mice's muscle cells, and excised from the gene a defective stretch of DNA known as an exon. Without the defective exon, the muscle cells made a shortened dystrophin protein that was nonetheless functional, giving all of the mice more strength."

An anonymous reader writes: A lengthy report at the Wall Street Journal brings allegations of data manipulation against blood-testing startup Theranos. The company raised hundreds of millions of dollars from investors, at a valuation of roughly $9 billion, on the hope that they can revolutionize medical diagnosis. They've also made agreements with Safeway and Walgreen's to offer blood tests within stores. But multiple former employees say Theranos was shaky on the science at best, and intentionally misrepresentative at worst.

Engineer Anthony Nugent says the device intended for Walgreen's was still experimental. He also recalls seeing the machines labeled "for investigational use only," because of poor accuracy. A Theranos lab worker "told federal authorities that the results from the quality-control runs diverged from the known amount by more than two standard deviations, a red flag that suggested possible accuracy problems." When that employee notified superiors within the company, somebody came and deleted the quality control data, which made the device's test runs appear better than they were. There are also reports that inspectors and auditors were purposefully kept away from parts of Theranos's lab. A Theranos spokesperson denied everything.

Press2ToContinue writes with this profile of Anatoli Brouchkov, a scientist who isn't afraid to take an extremely hands-on approach to science. Vice reports: "Anatoli Brouchkov is a soft-spoken guy with silver hair, and when he lets out a reserved chuckle, his eyes light up like he was belly laughing. If you met him on the street, you'd never guess that he once injected himself with a 3.5 million-year-old strain of bacteria, just to see what would happen. According to Brouchkov, Bacillus F has a mechanism that has enabled it to survive for so long beneath the ice, and that the same mechanism could be used to extend human life, too—perhaps, one day, forever. In tests, Brouchkov says the bacteria allowed female mice to reproduce at ages far older than typical mice. Fruit flies, he told the Siberian Times, also experienced a 'positive impact' from exposure to the bacteria."

neoritter writes: The issues of reproducibility in journals continues to present problems. This time in the world of clinical geneticists where a misleading or incorrect journal on the effect of a gene variant can affect the decisions made by doctors and patients alike; from heart monitoring implants to abortions. Poor sampling and low thresholds for evidence have led some clinical geneticists to work towards an open database of genetic information. Scientists and doctors would go to a "one-stop shop for disease genes" to check and share information with each other under the strictest of standards.

HughPickens.com writes: Lisa Jenning reports at Restaurant News that Chipotle plans to do DNA-based tests of all fresh produce before it is shipped to restaurants. The Centers for Disease Control and Prevention says that the E. coli outbreak linked to Chipotle now includes seven more people in three new states, including Illinois, Maryland and Pennsylvania, for a total count of 52 sickened in nine states. Most of the illnesses were in Washington, with 27 cases, and Oregon, with 13 cases. Twenty people have been hospitalized but there have been no reported deaths. Health officials say a meal or ingredient from Chipotle was likely the cause, but they have not yet identified the specific source of the outbreak. Chipotle's founder and co-chief executive, Steve Ells apologized to patrons who fell ill after eating at the company's restaurants. "This was a very unfortunate incident and I'm deeply sorry that this happened, but the procedures we're putting in place today are so above industry norms that we are going to be the safest place to eat." The chain will begin end-of-shelf-life testing to ensure quality specifications are met throughout the shelf life of products. The data collected will be used to measure the performance of vendors and suppliers to enhance food safety throughout the system.

But food safety experts are mixed about the effectiveness of such screening efforts for the prevention of foodborne illness. Bob Whitaker, chief science and technology officer for the Produce Marketing Association, says such tests are not practical as a screening tool. Instead, restaurant chains should focus on whether their suppliers have adequate food-safety programs in place. "You can't test your way to safety," says Whitaker. "The problem with product testing by itself is that it's hard to take enough samples to be confident that the product is free of any pathogens." DNA tests are considered among the most accurate and fast, with same-day testing available for organisms like E. coli or salmonella, says Morgan Wallace. Some manufacturers don't wait for results, since produce is perishable, but that introduces the risk of a produce recall if a pathogen has been identified after shipment. Others hold the product until test results are confirmed, but that practice adds holding costs and reduces the shelf life.

TheAlexKnapp writes: In a recent paper (abstract), a team used techniques from computational topology to look at the neural activity in the rat hippocampus as it solved a maze. Mathematician Kevin Knudson explains the findings: "This is the first time geometric structure has been found intrinsically in neural data. Certainly such a structure is to be expected since the rat's place cells keep track of the geometry of the environment, but this result is confirmation that it can be detected using only the pattern of correlations among the neurons. And it suggests that such geometric structure is a property of the underlying place cell network and not a result of the spatial structure of the input cells."

schwit1 writes with news that using gene editing technology researchers have bred pigs that do not produce a protein necessary for the Porcine Reproductive and Respiratory Syndrome (PRRS) virus to spread. According to Reuters: "A British animal genetics firm, working with U.S. scientists, has bred the world's first pigs resistant to a common viral disease, using the hot new technology of gene editing. Genus, which supplies pig and bull semen to farmers worldwide, said on Tuesday it had worked with the University of Missouri to develop pigs resistant to Porcine Reproductive and Respiratory Syndrome Virus (PRRSv). The condition, also known as blue-ear disease, can be fatal as it affects the animals' immune system and costs farmers hundreds of millions of dollars a year. There is no cure. By using precise gene editing, the team from the University of Missouri was able to breed pigs that do not produce a specific protein necessary for the virus to spread in the animals. Their research was published in journal Nature Biotechnology."

Eloking sends a report on new research from MIT, where scientists have developed a promising technique to shrink cancerous tumors. By "twisting RNA strands into a triple helix and embedding them in a biocompatible gel," they were able to efficiently deliver the RNA to tumor cells. "Using this technique, the researchers dramatically improved cancer survival rates by simultaneously turning on a tumor-suppressing microRNA and de-activating one that causes cancer. They believe their approach could also be used for delivering other types of RNA, as well as DNA and other therapeutic molecules. ... Once placed on the tumor, the gel slowly releases microRNA-dendrimer particles, which are absorbed into the tumor cells. After the particles enter the cells, enzymes cut each triple helix into three separate microRNA strands."

Josiah Zayner, a research fellow at NASA Ames Research Center, is running an Indiegogo campaign to make DIY gene editing kits that use the CRISPR technique to modify DNA. The campaign has already exceeded its goal, and he points out an article at Motherboard noting the controversy surrounding cheap, DIY genetic modification. Quoting:The kits won't going to allow people to genetically modify humans, but Zayner is still getting some heat for the project. One medical doctor emailed him with "grave concerns" about putting the technology in the hands of lay people. "Reprogramming bacteria or fungi could have serious ramifications, such as inadvertent or intended multi-drug resistance, faster multiplication, toxin production, and persisting potency when aerosolized," the doctor wrote. ... There is no legal framework surrounding this at-home work, unless it results in a product to be distributed, said Todd Kuiken, a senior program associate with the Synthetic Biology Project at the Woodrow Wilson International Center for Scholars. "Who actually uses kits like these and what they are using them for will determine if any of these products they make would be regulated or not," he said.

transporter_ii writes: Scientists from University College London seem to have come up with a two-pronged treatment regimen they believe would help patients suffering from chronic pain. And in a strange irony, they did it by making it possible for mice – and one human – to feel pain when they previously couldn't. From the story: "To examine if opioids were important for painlessness, the researchers gave naloxone, an opioid blocker, to mice lacking Nav1.7 and found that they became able to feel pain. They then gave naloxone to a 39-year-old woman with the rare mutation and she felt pain for the first time in her life. 'After a decade of rather disappointing drug trials, we now have confirmation that Nav1.7 really is a key element in human pain,' says senior author Professor John Wood (UCL Medicine). 'The secret ingredient turned out to be good old-fashioned opioid peptides, and we have now filed a patent for combining low dose opioids with Nav1.7 blockers. This should replicate the painlessness experienced by people with rare mutations, and we have already successfully tested this approach in unmodified mice.'"

trbdavies writes: Reporting from the CRISPR (clustered regularly interspaced short palindromic repeats) gene-editing summit in D.C., the Washington Post quotes Harvard genetics professor George Church as expressing "confidence that in just five or six years he will be able to reverse the aging process in human beings." He says: "A scenario is, everyone takes gene therapy — not just curing rare diseases like cystic fibrosis, but diseases that everyone has, like aging," CRISPR is a powerful technology, but many at the summit have expressed caution about both the ethics and the feasibility of using it to cure disease. The story quotes Klaus Rajewsky, of the Max Delbruck Center for Molecular Medicine saying "We have become masters in the art of manipulating genes, but our understanding of their function and interaction is far more limited."

An anonymous reader sends word that a three-day summit has begun in Washington to discuss the future of genetic engineering. It has a particular focus on the CRISPR technique, which has made gene editing quicker and more robust than ever before. "The reason CRISPR is so controversial is that it works well on 'germline' cells, such as sperm, eggs and embryonic cells, and the genetic editing results in heritable traits. Many scientific organizations have called for a time-out on any experiments on human cells, fearing that this crosses into dicey ethical territory. This meeting in Washington could potentially generate a new call for restraint, or some guidelines in how to handle the explosive technology." Many scientists, lawyers, and policymakers are present at the summit to try to reach consensus on how the scientific community should proceed with such research, and how the fruits of their research should be used. Professor Alta Charo said, "The more we can have effective systems for responsible oversight for the development and deployment of a technology, the more we can take chances. We have the chance to back up at the end, and change course."

AmiMoJo writes: Omikenshi Co, an Osaka based cloth manufacturer best known for rayon, a fibre made from tree pulp, is expanding into the health food business. Using a similar process, Omikenshi is turning the indigestible cellulose into a pulp that's mixed with konjac, a yam-like plant grown in Japan. The resulting fibre-rich flour, which the company calls "cell-eat," contains no gluten, no fat and almost no carbohydrate. It has just 60 calories a kilogram, compared with 3,680 for wheat.