Category Archives: Gene Medicine

When Nisa Leung was pregnant with her first child in 2012, her doctor in Hong Kong offered her a choice. She could take a prenatal test that would require inserting a needle into her uterus, or pay $130 more for an exam that would draw a little blood from her arm.

Leung opted for the simpler and less risky test, which analyzed bits of the babys DNA that had made its way into her bloodstream. Then, Leung went on to do what she often does when she recognizes a good product: look around for companies to invest in.

The managing partner at Qiming Venture Partners decided to put money into Chinese genetic testing firm Berry Genomics, which eventually entered into a partnership with the Hong Kong-based inventor of the blood test. Over the next few months, Berry is expected to be absorbed into a Chinese developer in a 4.3 billion yuan ($625 million) reverse merger. And Leungs venture capital firm would be the latest to benefit from a boom in so-called precision medicine, an emerging field that includes everything from genetic prenatal tests to customizing treatments for cancer patients.

Source: Qiming Venture Partners

China has made the precision medicine field a focus of its 13th five-year plan, and its companies have been embarking on ambitious efforts to collect a vast trove of genetic and health data, researching how to identify cancer markers in blood, and launching consumer technologies that aim to tap potentially life-saving information. The push offers insight into Chinas growing ambitions in science and biotechnology, areas where it has traditionally lagged developed nations like the U.S.

Investing in precision medicine is definitely the trend, said Leung,whos led investments in more than 60 Chinese health-care companies in the past decade. As China eyes becoming a biotechnology powerhouse globally, this is an area we will venture into for sure and hopefully be at the forefront globally.

New Chinese firms like iCarbonX and WuXi NextCode that offer consumers ways to learn more about their bodies through clues from their genetic make up are gaining popularity. Chinese entrepreneurs and scientists are also aiming to dominate the market for complex new procedures like liquid biopsy tests, which would allow for cancer testing through key indicators in the blood.

iCarbonX founder Wang Jun.

Photographer: Calvin Sit/Bloomberg

Such research efforts are still in early stages worldwide. But doctors see a future beyond basic commercial applications, aiming instead for drugs and treatment plans tailored to a persons unique genetic code and environmental exposure, such as diet and infections.

Isaac Kohane, a bioinformatics professor at Harvard University, says when it comes to precision medicine, the science community has Google maps envy. Just as the search engine has transformed the notion of geography by adding restaurants, weather and other locators,more details on patients can give doctors a better picture on how to treat diseases.

For cancer patients, for example, precision medicine might allow oncologists to spot specific mutations in a tumor. For many people with rare ailments like muscle diseases or those that cause seizures, it allows for earlier diagnosis. Pregnant women, using the kind of tests that Leung used, could also learn more about the potential for a child to inherit a genetic disease.

The global interest in the field comes as the cost of sequencing DNA, or analyzing genetic information, is falling sharply. But a number of hurdles remain. Relying on just genes isnt enough, and there must also be background information on a patients lifestyle and medication history.

Precision medicine applications also require heavy investment to store large amounts of information. A whole genome is over 100 gigabytes, according toan e-mailed response to questions from Edward Farmer, WuXi NextCodes vice-president of communications and new ventures. So you can imagine that analyzing thousands or hundreds of thousands of genomes is a true big data challenge."

WuXi NextCode was formed after Shanghai-based contract research giant WuXi AppTec Inc. acquired genomic analysis firm NextCode Health, a spin-off from Reykjavik, Iceland-based Decode Genetics, which has databases on the islands population. Wuxi NextCode continues to have an office in Iceland, where the population is relatively homogenous and therefore good for gene discovery.

Source: WuXi NextCODE

"Genomics today is like the computer industry in the 70s," said Hannes Smarason, WuXi NextCodes co-founder and chief operating officer. "Weve made great progress but theres still a long way to go.

In China, Wuxi NextCode now offers consumers genetic tests that cost between about 2,500 yuan and 8,000 yuan, providing more details on rare conditions a child might be suffering from or even the risk of passing on an inherited disease.

China is diverse and with 1.4 billion people, the planets most populous nation. WuXi NextCode announced a partnership with Huawei Technologies Co.,Chinas largest telecommunications equipment maker, in May to enable different institutions and researchers to store their data.

The goal is to use that deep pool of information -- which ranges from genome sequences to treatment regimens -- to find more clues on tackling diseases. WuXi says that this will in many instances enable the largest studies ever undertaken in many diseases.

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The global precision medicine market was estimated to be worth $56 billion in revenue at the end of 2016,with China holding about 4 to 8 percent of the global market, according to a December report from Persistence Market Research.

Encouraging interventions for some patients too early, even before they have life-threatening diseases, comes with risks and ethical questions, Laura Nelson Carney,an analyst at Sanford C Bernstein, wrote in a Jan. 6 note. Still, precision medicine research has many benefits, and some in China see the countrys push as a significant opportunity "to scientifically leapfrog the West, she said.

In the U.S., universities, the National Institutes of Health and American drugmakers are part of a broad march into precision medicine.

Amgen Inc. bought Icelandic biotechnology company DeCode Genetics for $415 million in 2012, to acquire its massive database on Icelands population. U.S.-based Genentech Inc. is collaborating with Silicon Valley startup 23andMe to study the genetic underpinnings of Parkinsons disease.

Humans are computable," saidWang Jun, the chief executive officer of ChinasiCarbonX. "So we need a computable model that we can use to intervene and change peoples status, thats the whole point.

Read more from the original source:
China Turns to Precision Medicine in Fight Against Cancer ... - Bloomberg

U.S. Army scientists, working with medical technology companies, have successfully tested and used products and techniques that have enabled Army surgeons to replace the severely burned skin of soldiers as well as transplant new hands and even faces.

At Duke University, researchers are studying zebra fish to learn how science and medicine might someday be able to regenerate severed human spinal cords.

These examples one already in practice and the other in the early research stages illustrate the potential that regenerative medicine offers for the future of medical care.

This research aims to go beyond easing the pain of life-threatening illnesses by changing the way diseases affect the body and then eradicating them.

The vast majority of currently available treatments for chronic and/or life-threatening diseases are palliative, Morrie Ruffin, managing director of the Alliance for Regenerative Medicine (ARM), told Healthline.

ARM, based in Washington, D.C., is considered the preeminent global advocate for regenerative and advanced therapies.

Other treatments delay disease progression and the onset of complications associated with the underlying illness, he said. Very few therapies in use today are capable of curing or significantly changing the course of disease.

Regenerative medicine has the unique ability to alter the fundamental mechanisms of disease, and thereby offer treatment options to patients where there is significant unmet medical need.

And it has the potential to address the underlying causes of disease, Ruffin said, representing a new and growing paradigm in human health.

The field encompasses a number of different technologies, including cell, gene, and tissue-based therapies.

Read more: Re-growing teeth and healing wounds without scars

With the Army breakthroughs, government investment was key.

The U.S. Department of Defense (DOD) has invested more than $250 million in regenerative medicine research over the past decade in an effort to make promising technologies available to wounded service members.

Dr. Wendy Dean is medical officer for the Tissue Injury and Regenerative Medicine Project Management Office at the U.S. Army Medical Materiel Development Activity at Fort Detrick, Md., home to the Armys Medical Research and Materiel Command.

Those investments have yielded a stress-shielding surgical bandage, Embrace, to reduce scarring after surgery, Dean told Healthline. The research has also enabled tremendous progress in burn care, allowing surgeons to improve recovery from severe burns with the use of novel skin replacement strategies, such as ReCell spray-on skin, or skin substitutes such as StrataGraft. These skin replacement methods reduce or eliminate the need for donor sites, a frequent request of burn patients.

These revolutionary products were not developed by the Army, Dean said, but were supported with research funding, initially through the Armed Forces Institute of Regenerative Medicine.

The DOD also has invested in hand and face transplantation efforts for service members and civilians whose injuries are so severe that conventional reconstruction is insufficient, she said.

Dean noted that DOD funding has supported 13 hand transplants to date, including a transplant for retired Sgt. Brendan Marrocco in 2012. He was the first service member to survive quadrilateral amputations sustained in combat. The funding also supported eight face transplants.

The Armys goal is to heal those injured in battle.

Regenerative medicine is still young, but it has shown tremendous progress over the last decade, Dean said. Our mission is to make wounded warriors whole by restoring form, function, and appearance. This field offers the best hope to someday fully restore lost tissue with tissue that is structurally, functionally, and aesthetically a perfect match. It may be years before the vision is a widespread reality, but the field is well on its way.

Read more: Regenerative medicine doctor says forget the pills

At Duke University, Kenneth Poss, professor of cell biology, and director of the Regeneration Next initiative, was the senior investigator for a study of spinal cord regeneration in zebra fish.

Those findings were published in November in the journal ScienceDaily.

In my lab, we are researching genetic factors that enable regeneration of tissues such as heart and spinal in nonmammalian animals like zebra fish, Poss told Healthline. A scientist in my lab, Mayssa Mokalled, led a study finding that a gene called connective tissue growth factor [CTGF] is important for spinal cord regeneration in zebra fish after an injury that completely severs the cord.

CTGF is necessary to stimulate cells called glia to form a tissue bridge across the severed parts of the spinal cord an early step in spinal cord regeneration.

Within eight weeks, the scientists found that zebra fish regenerate a severed spinal cord, including nerve cells, and fully reverse their paralysis.

Developing techniques to treat and reverse spinal cord damage, a paralyzing and often fatal injury, is a pressing need in regenerative medicine, Poss said.

Our findings present a step toward understanding which glial cells can be encouraged to help heal the spinal cord, and how to stimulate this activity, he said. This is just the first step in many before the findings could be applied to humans.

Poss is already planning trials with mice that he hopes to start in the next few months. Mice represent an important stage in applying his latest findings, he said.

Read more: Should you store or donate your childs umbilical cord blood?

So, why is regenerative medicine important?

Regenerative medicine seeks ways to re-grow or engineer healthy tissue without the need for transplants, Poss said. On a global scale, theres a tremendous organ shortage, and transplantation is an expensive and nonpermanent solution.

Imagine the number of lives that could be improved if, for example, we could find ways to use the bodys innate healing mechanisms to regenerate heart muscle in patients that are spiraling toward heart failure after a heart attack.

Imagine how many lives could be improved if we could find interventions that restore functional spinal cord tissue and reverse paralysis.

Ruffin of ARM sees a promising future for regenerative medicine.

We will continue to see the development of additional regenerative medicine therapies for a broad number of acute and chronic, inherited and acquired diseases and disorders, he said. Therapies in this area will continue to advance along the regulatory pathway, many of which are entering phase III clinical trials this year.

In fact, in the next two years, we are anticipating a number of U.S. and E.U. approvals in the cell and gene therapy sector, including therapies that address certain types of cancers, debilitating retinal disorders, rare genetic diseases, and autoimmune conditions. We also expect to see sustained investment, which will help fuel growth and product development within this sector.

A number of cell and gene therapies and technology platforms are demonstrating real potential to address areas of significant unmet medical need, Ruffin said.

These include cell therapies for blood cancers and solid tumors; gene therapies for rare genetic diseases as well as chronic conditions; and gene editing for the precise targeting and modification of genetic material of a patients cells to cure a broad range of diseases with a single treatment.

Poss at Duke talked about the ultimate quest.

Regenerative medicine has been most successful in restoring or replacing the hematopoietic tissue that creates blood, he said.

We still lack successful regenerative therapies for most tissues, Poss said. The future of regenerative medicine the holy grail will be stimulating the regeneration of healthy tissue in patients without adding cells or manufactured tissue.

Working out the details of innate mechanisms of regeneration in animals like salamanders, zebra fish, and mice, can inform this approach, he said. So can improvement in factor delivery and genome editing applications to encourage the regeneration of healthy tissue.

Ultimately, Poss said, regenerative medicine will change the toolbox of physicians and surgeons, with major impact on outcomes of diabetes, spinal cord injuries, neurodegenerative disease, and heart failure.

ARM says the public does not realize how far the field has progressed in recent years.

Currently, there are more than 20 regenerative medicine products on the market, Ruffin said, primarily in the therapeutic areas of oncology, musculoskeletal and cardiovascular repair, and wound healing.

More than 800 clinical trials are now underway to evaluate regenerative advanced therapies in a vast array of therapeutic categories, he said.

Were seeing a significant focus on oncology, cardiovascular disease, and neurodegenerative diseases, with more than 60 percent of trials falling into one of these three categories, he added. Even though the majority of people perceive regenerative medicine as something of the future, its actually here and now.

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Regenerative Medicine Has a Bright Future - Healthline

Research by Professor of Chemical and Biomolecular Engineering Huimin Zhao and graduate student Behnam Enghiad at the University of Illinois is pioneering a new method of genetic engineering for basic and applied biological research and medicine. Their work, reported in ACS Synthetic Biology on February 6 [DOI:10.1021/acssynbio.6b00324], has the potential to open new doors in genomic research by improving the precision and adherence of sliced DNA.

"Using our technology, we can create highly active artificial restriction enzymes with virtually any sequence specificity and defined sticky ends of varying length," said Zhao, who leads a synthetic biology research group at the Carl R. Woese Institute for Genomic Biology at Illinois. "This is a rare example in biotechnology where a desired biological function or reagent can be readily and precisely designed in a rational manner."

Restriction enzymes are an important tool in genomic research: by cutting DNA at a specific site, they create a space wherein foreign DNA can be introduced for gene-editing purposes. This process is not only achieved by naturally-occurring restriction enzymes; other artificial restriction enzymes, or AREs, have risen to prominence in recent years. CRISPR-Cas9, a bacterial immune system used for "cut-and-paste" gene editing, and TALENs, modified restriction enzymes, are two popular examples of such techniques.

Though useful in genetic engineering, no AREs generate defined "sticky ends" -- an uneven break in the DNA ladder-structure that leaves complementary overhangs, improving adhesion when introducing new DNA. "If you can cleave two different DNA samples with the same restriction enzyme, the sticky ends that are generated are complementary," explained Enghiad. "They will hybridize with each other, and if you use a ligase, you can stick them together."

However, restriction enzymes themselves have a critical drawback: the recognition sequence which prompts them to cut is very short -- usually only four to eight base pairs. Because the enzymes will cut anywhere that sequence appears, researchers rely on finding a restriction enzyme whose cut site appears only once in the genome of their organism or plasmid -- an often difficult proposition when the DNA at hand might be thousands of base pairs long.

This problem has been partially solved simply by the sheer number of restriction enzymes discovered: more than 3600 have been characterized, and over 250 are commercially available. "Just in our freezer, for our other research, we have probably over 100 different restriction enzymes," said Enghiad. "We look through them all whenever we want to assemble something ... the chance of finding the unique restriction site is so low.

"Our new technology unifies all of those restriction enzymes into a single system consisting of one protein and two DNA guides. Not only have you replaced them, but you can now target sites that no available restriction enzymes can."

Enghiad and Zhao's new technique creates AREs through the use of an Argonaute protein (PfAgo) taken from Pyrococcus furiosus, an archeal species. Led by a DNA guide, PfAgo is able to recognize much longer sequences when finding its cut site, increasing specificity and removing much of the obstacles posed by restriction enzymes. Further, PfAgo can create longer sticky ends than even restriction enzymes, a substantial benefit as compared to other AREs.

"When we started, I was inspired by a paper about a related protein -- TtAgo. It could use a DNA guide to cleave DNA, but only up to 70 degrees," explained Enghiad. "DNA strands start to separate over 75 degrees, which could allow a protein to create sticky ends. If there were a protein that was active at higher temperatures, I reasoned, that protein could be used as an artificial restriction enzyme.

"So I started looking for that, and what I found was PfAgo."

In addition to replacing restriction enzymes in genetic engineering processes, Enghiad and Zhao believe their technology will have broad applications in the biological research. By creating arbitrary sticky ends, PfAgo could make assembly of large DNA molecules easier, and enables cloning of large DNA molecules such as biochemical pathways and large genes.

The application of these techniques is broad-reaching: ranging from discovery of new small molecule drugs to engineering of microbial cell factories for synthesis of fuels and chemicals to molecular diagnostics of genetic diseases and pathogens, which are the areas Zhao and Enghiad are currently exploring.

"Due to its unprecedented simplicity and programmability (a single protein plus DNA guides for targeting), as well as accessibility ... we expect PfAgo-based AREs will become a powerful and indispensable tool in all restriction enzyme or nuclease-enabled biotechnological applications and fundamental biological research," said Zhao. "It is to molecular biology as the CRISPR technology is to cell biology."

Excerpt from:
New method of genetic engineering indispensable tool in ... - Science Daily

A pediatrician decides a struggling teen with mental illness needs hospitalization to neutralize psychologic demons impacting their personal and social life.

A workers compensation doctor requests a neck MRI in a powerline worker with growing right arm numbness and weakness to search for potential paralyzing nerve impingement.

An orthopedist orders special testing to determine if an elder patient with right hip pain which limits walking and driving might need surgery to improve her quality of life.

Physicians are rigorously trained to make decisions in the best interest of their patients. Even after medical school and residency, doctors must follow the challenges of evidence-based medicine, standard of care, peer review, and muster the time for continuing medical education and certification.

Doctors are not only held accountable by their peers, but also legally, as they could be subject to lawsuits. Additionally, state licensing agencies that oversee medical professionals can discipline them, should they not practice medicine up to the standards of quality medical decision-making.

However, what if the teens pediatrician feels hospitalization is acutely needed for mental illness, but it is denied by the insurance company? What if the workers comp physician orders an MRI for the powerline workers ailing right arm, but it is denied? Or, if special testing to evaluate grandmas worsening mobility and pain is turned down by the HMO? Who is held accountable?

To justify requests for specific patient care, physicians are forced to have peer-to-peer phone discussions with doctors employed by insurance companies, workers comp and HMOs. Frequently, these conversations result in denial of further care without medical justification.

A controversial question arises: Are denials by these company doctors considered medical decisions?

They are not. These decisions are considered utilization review. What does this mean? They are making decisions based on controlling costs, which is in the financial interest of the for-profit agencies they serve but not necessarily in the best interest of the patient.

Even though they are licensed doctors practicing medicine, their role in patient care is under the guise of utilization review and therefore not under the scrutiny of state licensing agencies.

What if these physicians deny care because they are incentivized to enhance personal bonuses? More so, what if some are making decisions outside the realm of their medical expertise (e.g., a urologist deciding about a diabetic)? Who holds these physicians accountable for moral transgressions or lack of judgement?

In California, we have a Medical Board that oversees licensing for all state physicians. If you report a licensed physician for making substandard medical decisions, an investigation ensues. If, though, the doctor is employed by an insurance company, workers comp or HMO and makes denial decisions on their behalf, it is considered utilization review, and they are not held accountable.

I do not pretend to understand every law and rule governing the Medical Board. But these companies have created legal barriers protecting doctors who might make substandard medical decisions.

Many physicians continue to fight for patient care rights despite frustration and helplessness of ongoing phone calls and paperwork they face. Yet substandard medical care will hamper their efforts as laws are manipulated and oversight is negligible.

Making medical decisions has never been easy. Assuring accountability makes it even harder.

Gene Uzawa Dorio, M.D., is a housecall geriatric physician and member of thePhysicians Organizing Committee atHenry Mayo Newhall Hospital. The views expressed in this column as his alone.

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Non-Medical Medical Decisions | Commentary by Dr. Gene Dorio - SCVNEWS.com

Using stem cells and gene therapy to treat orcure disease may still sound like science fiction, but a scientific meeting here last week emphasizedall the fronts onwhich it is moving closer and closer to fact.

Were entering a new era in medicine, said Lloyd Minor, MD, dean of the School of Medicine, in his opening remarks at the first annual symposium of the schools new Center for Definitive and Curative Medicine. Stanford researchersare poised to use stem cells and gene therapy to amelioratea wide swath of diseases, from common diagnoses such as diabetes and cancerto rare diseases ofthe brain, blood, skin, immune system and other organs. Ultimately, the goal is to create one-time treatments that can provide lifetime cures; hence the definitive and curative part of the centers name. Stanford is a leader in this branch of medical research, Minor said, addingThis is a vital component of our vision for precision health.

Stanford has a long history of leading basic-science discoveries in stem cell biology, andis now engaged in studyingmany different ways those discoveries couldbenefit patients, saidMaria Grazia Roncarolo, MD, who leads the new center.Our job is to produce clinical data so compelling that industry will pick up the product and take it to the next stage, Roncaraolo told the audience.

Among otherevent highlights:

More coverage of the days events is available in a story from the San Jose Mercury News that describeshowAnthonyOro, MD, PhD, and his colleagues are fighting epidermolysis bullosa, a devastating genetic disease of the skin. Oro closed his talk with a slightly goofy photo of a man getting a spray tan. It got a laugh, but his point was serious: Our goal for the cell therapy of the future is spray-on skin to correct a horrible genetic disease.

Ambitious? Yes. Science fiction? In the future, maybe not.

Previously: One of the most promising minds of his generation: Joseph Wu takes stem cells to heart,Life with epidermolysis bullosa: Pain is my reality, pain is my normaland Rat-grown mouse pancreases reverse diabetes in mice, say researchers Photo of Matthew Porteus courtesy of Stanford Childrens

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Stanford scientists describe stem-cell and gene-therapy advances in scientific symposium - Scope (blog)

February 10, 2017

An article published in Experimental Biology and Medicine (Volume 242, Issue 3, February, 2017) identifies microRNAs (miRNAs) as key factors in some hemoglobinopathies, genetic disorders characterized by alterations in the level or structure of the globin proteins that are responsible for oxygen transport in the blood. The study, led by Dr. Thais Fornari, from the Department of Internal Medicine at the University of Campinas in Brazil demonstrated that differential expression of miRNAs may be responsible for the variations in globin gene expression observed in patients with two hemoglobinopathies: hereditary persistence of fetal hemoglobin deletion type 2 (HPFH-2) and Sicilian-thalassemia.

HPFH-2 and Sicilian-thalassemia are conditions described as large deletions of the human -like globin cluster, with no -globin expression and compensatory increases in -globin expression. MicroRNAs (miRNAs) are small non-coding RNAs that participate in a wide range of biological processes including erythropoiesis. miRNAs silence the expression of other genes by binding to their mRNAs, and blocking protein synthesis and/or initiating mRNA degradation. Transcription factors such as BCL11A and SOX6, which regulate -globin gene expression, are potential targets for several microRNAs based on in silico analysis. Thus, novel miRNA-mediated pathways may explain the differences in the expressions of -globin in Sicilian thalassemia and HPFH-2.

In the current study, Dr. Fornari and colleagues compared the miRNA profiles of erythroid cells derived from individuals heterozygous for HPFH-2 and Sicilian-thalassemia. Forty-nine differentially expressed miRNAs that may participate in -globin gene regulation and red blood cell function were identified. Twelve of these miRNAs potentially targeted the BCL11A gene, and down-regulation of BCL11A gene expression in HPFH-2 was verified by qPCR. This research suggests an important action of miRNAs in the regulation of globin expression in patients. Fornari said that these findings "may partially explain the phenotypic differences between HPFH-2 and Sicilian -thalassemia and the variable increases in -globin gene expression in these conditions. Moreover, these data support erythroid BCL11A as a therapeutic target for sickle cell disease and -thalassemia major patients."

Dr. Steven R. Goodman, editor-in-chief of Experimental Biology and Medicine, said, "Fornari and colleagues provide further evidence for the role of miRNA networks in the regulation of fetal hemoglobin expression, via altered expression of BCL11A and SOX6. These studies are important when considering these transcription factors as potential therapeutic targets".

Explore further: Mechanisms, therapeutic targets of microRNA-associated chemoresistance in epithelial ovarian cancer

Journal reference: Experimental Biology and Medicine

Provided by: Experimental Biology and Medicine

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Researchers find potential treatments for hemoglobinopathies - Medical Xpress