BOTHELL, WA–(Marketwire -02/22/12)- AVI BioPharma, Inc. (NASDAQ: AVII – News), a developer of RNA-based therapeutics, announced today that it received a letter from the listing qualifications department staff of The NASDAQ Stock Market LLC, stating that the Company has regained compliance with NASDAQ's minimum $1.00 per share bid price requirement.

The letter received noted that for 10 consecutive business days, from February 6, 2012 to February 17, 2012, the closing bid price of the Company's common stock was $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5450(a)(1) and the matter is closed.

About AVI BioPharma

AVI BioPharma is focused on the discovery and development of novel RNA-based therapeutics for rare and infectious diseases, as well as other select disease targets. Applying pioneering technologies developed and optimized by AVI, the Company is able to target a broad range of diseases and disorders through distinct RNA-based mechanisms of action. Unlike other RNA-based approaches, AVI's technologies can be used to directly target both messenger RNA (mRNA) and precursor messenger RNA (pre-mRNA) to either down-regulate (inhibit) or up-regulate (promote) the expression of targeted genes or proteins. By leveraging its highly differentiated RNA-based technology platform, AVI has built a pipeline of potentially transformative therapeutic agents, including eteplirsen, which is in clinical development for the treatment of Duchenne muscular dystrophy, and multiple drug candidates that are in clinical development for the treatment of infectious disease. For more information, please visit www.avibio.com.

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AVI BioPharma Regains NASDAQ Compliance

The event, on March 21, will bring together private and public sector organisations and individuals associated with the treatment, care, rehabilitation, education and training of affected people.

Organised by the Language Centre Social Committee in collaboration with the College of Medicine and Health Sciences at Sultan Qaboos University (SQU) and to be inaugurated by Sayyid Saud bin Hilal Al Busaidi, Minister of State and Governor of Muscat, the conference will involve a number of training workshops conducted by leading experts from within and outside the country.

“Hopefully it will include a recommendation for the establishment of a centre for autism that will monitor the status of patients and activate the programme for their care, treatment and rehabilitation,” Anfal bint Nasser Al Wahibiyah, Executive Chairperson of the conference, said.

She said the event, titled ‘Accepting Difference’, would cover four main themes — modern trends in the diagnosis and treatment of autism; education of affected children; the role of the society in caring for autistic children; and training of specialists in the field.

She said the conference would provide professionals and parents a clearer understanding of the diagnostic criteria and essential strategies for education, behaviour management and communication associated with autism.

She added some 500 people, including parents, teachers, health care professionals, psychologists, social workers and volunteers were expected to attend the event.

ravindranath@khaleejtimes.com

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Oman set to host first global autism conference

University Hospitals Case Medical Center will be one of 25 institutions in the U.S. to take part in a phase 2 clinical trial of a stem cell treatment for stroke developed by Cleveland-based Athersys (NASDAQ:ATHX).

The Plain Dealer reports that MultiStem will be administered via a one-time IV infusion to 140 patients at UH and the other sites over the next 18 months to test for effectiveness and safety.

Ischemic stroke appears to be the most promising application of MultiStem, an off-the-shelf stem cell treatment derived from the bone marrow of adults or other nonembryonic sources that’s also being tested for use in treating blood diseases, traumatic brain injury, heart attack, multiple sclerosis and inflammatory bowel disease.

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Caused by a blood clot in the brain, ischemic stroke accounts for 87 percent of all stroke cases and represents a market that Athersys executives have pegged at $15 billion. Current treatment referred to as clot-buster therapy has to be administered within four and a half hours after stroke to be effective; MultiStem can be delivered 24 to 36 hours after stroke.

Athersys first outlined plans for this phase 2 clinical study back in September.

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Athersys, University Hospitals partner for clinical trials of MultiStem for stroke

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A £1.13m centre offering therapy to Multiple Sclerosis sufferers has opened near Bristol.

The charity behind the centre in Bradley Stoke has moved there from Nailsea where it has provided therapy for 25 years.

The centre will support up to 600 people and will provide treatments such as physiotherapy and reflexology.

Mike Gelder, of the Moonstone Appeal, which raised funds to build the centre, said it was a “very exciting moment”.

He said: “We are very pleased to be at this point after many years of hard work raising the funds needed for the centre, planning, and building the facility which will provide so much vital support for people living with MS in this region.”

The centre in Wheatfield Drive has been under construction since May last year.

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MS treatment centre opens doors

By Julia Karow

Next-gen sequencing for clinical applications and medical research were big themes at this year's Advances in Genome Biology and Technology meeting in Marco Island, Fla., reflecting the technology's continued move into medicine over the last year.

Three conference sessions had a medical theme this year, focusing on the clinical translation of genomics, medical sequencing and genetic variation, and cancer and transcriptomes.

And, probably for the first time at this meeting, conference attendees discussed the term “CPT code” — the number assigned to medical and diagnostic services by the American Medical Association to define reimbursement by insurance — in connection with next-gen sequencing-based tests.

“Last year, there were just some very preliminary studies that were really at the interface between the basic sciences and the clinic,” said Elaine Mardis, co-director of the Genome Institute at Washington University. “What we saw this year … is a focus on groups that are coming up with very defined content, looking very carefully at inherited diseases, and beginning to really transition many of the single-gene or small panel gene tests into now multiple-gene tests that really harness the capabilities of next-generation sequencing data.”

NGS Gene Panels

Heidi Rehm, director of the Laboratory for Molecular Medicine at the Partners Healthcare Center for Personalized Genetic Medicine in Boston, presented one of the more applied examples of sequencing in a clinical context.

Rehm's lab, which focuses on genetic testing for inherited cardiovascular disease, cancer, and hearing loss, recently merged several existing gene panel tests — some of them resequencing array-based — into a pan-cardiomyopathy panel that contains 46 cardiomyopathy genes and uses a combination of next-gen sequencing and Sanger sequencing.

The lab also recently converted its resequencing array-based OtoChip hearing loss test into a next-gen sequencing-based OtoGenome test, and plans to expand it from 19 to 73 genes this spring.

One of the challenges with these tests, Rehm said, has been the need to confirm results from next-gen sequencing by Sanger sequencing, and to fill in missing areas that are not covered, also using Sanger.

The need to interpret every variant identified in the target region has led to a jump in novel variants, which take considerable time to interpret through searches of databases, literature, and the use of functional prediction tools. For example, even after testing thousands of patients for hypertrophic cardiomyopathy, she said, about 17 percent of the identified mutations are novel, she said.

Rehm also called for a new, publicly available and curated clinical variant database, populated with data submitted by clinical laboratories. If a grant under submission at the National Institutes of Health is funded, she will lead the development of such a database, initially focused on eight disease areas.

Developing software to deliver clinical reports to physicians has been another focus of her team's work. Eight years ago, they began building a system to track knowledge about genetic variants and support laboratory reporting. The system, called GeneInsight Suite, is already used by a number of clinical labs. A clinical interface for this tool was added two years ago that allows doctors to receive patient alerts on variants via e-mail and obtain updated reports within the GeneInsight Clinic interface. Rehm said that a manuscript detailing her lab's experience with this system has been accepted for publication in a journal and will appear shortly. The software has also been registered with the US Food and Drug Administration as a class 1 medical device.

Besides moving gene panel tests to next-gen sequencing, the LMM is collaborating with genetics clinics at Brigham and Women's Hospital and Massachusetts General Hospital to develop a whole-genome sequencing interpretation service, and is currently outsourcing the sequencing to Illumina's CLIA laboratory (CSN 6/15/2011).

Diagnosing Severe Childhood Disorders

Darrell Dinwiddie, from the Center for Pediatric Genomic Medicine at Children's Mercy Hospital in Kansas City, presented another promising example of the clinical use of next-gen sequencing. He and his colleagues, led by Stephen Kingsmore, the center's director, have developed a test to diagnose more than 600 severe childhood diseases — all Mendelian disorders — using targeted resequencing (CSN 8/9/2011).

The test, originally developed by Kingsmore's team at the National Center for Genome Resources, covers about 8,400 genomic regions from 526 genes, as well as the mitochondrial genome. It is currently available under a research protocol to physicians at Children's Mercy Hospital, where it is validated in a CLIA and CAP-approved lab. Its turnaround time is about four weeks, and it will cost on the order of $750.

It does not include carrier testing and testing for adult-onset diseases as there would be no immediate benefit for the children tested, Dinwiddie explained.

Generating about 4 gigabases of data for each sample on the Illumina HiSeq platform results in at least 16x coverage for 98 percent of the targets, which are selected by Illumina's TruSeq capture method. The test's sensitivity for substitutions, insertions and deletions, splicing, gross deletions, and SNPs is more than 97 percent, and its specificity is 100 percent.

Insertions, deletions, and copy number variants account for between 5 percent and 20 percent of all disease-causing variants, Dinwiddie pointed out, but are difficult to find, and the test uses a two-step method to detect them.

To interpret the results, the researchers map clinical symptoms to genes and diseases that match these symptoms.

They also classify the identified variants into categories defined by the American College of Medical Genetics, ranging from previously reported variants that are a recognized cause of a disorder to variants that are unlikely to cause a particular disease.

The researchers are in the midst of a clinical validation of the test, which is nearly completed. For the first phase of the validation, they analyzed 96 samples that included cell lines from Coriell and HapMap samples. Phase two, a blinded study, involves 384 samples with known disease-causing mutations from Children's Mercy Hospital, and phase three comprises 110 samples with a known and 110 samples with an unknown molecular diagnosis from collaborators in Germany.

As an example of a successful use of the test in patients who received it under a research protocol, Dinwiddie presented the case of two siblings, age 5 and 9, who had undergone five years of testing that cost more than $23,000 but did not provide a molecular diagnosis.

Using their targeted sequencing test, he and his colleagues were able to identify known mutations in the aprataxin gene, which causes ataxia, and confirmed these results by Sanger sequencing. Both parents turned out to be carriers of the disease.

The molecular diagnosis even resulted in a new treatment for the children: since mutations in the aprataxin gene result in a deficiency of coenzyme Q10, the children now receive this as a medication. While their doctors are still working on the correct dosage, Dinwiddie said that the children are making “progressive improvement.”

On a research basis, Kingsmore's team has also been exploring the use of “emergency” whole-genome sequencing in newborns.

During an Illumina user meeting held at the conference, Kingsmore reported analyzing the genomes of two newborns with life-threatening genetic diseases in a neonatal intensive care unit.

Molecular diagnoses are almost never made for these patients, he explained, and doctors need to make quick decisions on their management, mostly based on their symptoms.

The genomes of the two patients, including their mitochondrial genomes, were sequenced by Illumina at high coverage on its new HiSeq 2500 sequencing system, which generated results within 50 hours, starting from sample preparation to interpreted results.

For the analysis, the researchers focused on a number of candidate genes that were suggested by the patients' phenotype and symptoms, with the aim to rule out a subset of treatable conditions where knowing the presence of a mutation could save the children's lives.

They assembled a variety of software tools, enabling them to come up with a “rapid diagnostic answer.” As in the targeted resequencing test, they did not look at carrier status or adult-onset diseases.

The researchers were unable to identify mutations that were either known to cause disease or novel and likely to cause disease, and both children eventually died. But the genome analysis was at least able to rule out certain disease causes, thus reducing unnecessary testing and the use of empirical therapies.

Positive results could have suggested other diagnostic tests for confirmatory testing, and would have been useful for prognostic assessments, genetic counseling of the parents, and targeted therapies in a subset of patients.

Thus, the study provided proof of concept for real-time genome sequencing to provide relevant medical results in life-threatening situations where a monogenic disease is suspected. A side benefit, he added, is a complete pharmacogenetic profile that may alter treatment choice.

Have topics you'd like to see covered in Clinical Sequencing News? Contact the editor at jkarow [at] genomeweb [.] com.

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Clinical Applications of Next-Gen Sequencing Debut at AGBT

Doctors Haeck, Eaves, and Rohrich write joint ASAPS/ASPS statement calling for more research into stem cell facelift and stem cell breast augmentation.

Dallas, TX (PRWEB) February 22, 2012

There is little evidence to support the safety and effectiveness of procedures, equipment and treatments that have been advertised using adult stem cells for aesthetic reconstruction, including plastic surgery and facial rejuvenation, according to physicians writing in Plastic and Reconstructive Surgery.

Dr. Rod J. Rohrich, chairman of the Department of Plastic Surgery at UT Southwestern Medical Center and editor-in-chief of the journal, published a position statement on “stem cell facelifts” and “stem cell breast augmentation,” also known as “natural breast augmentation.” Dr. Felmont F. Eaves III of Chapel Hill, N.C., and Dr. Phillip C. Haeck of Seattle, Wash.,collaborated on the statement on behalf of the American Society for Aesthetic Plastic Surgery (ASAPS) and the American Society of Plastic Surgeons (ASPS).

“There are encouraging data from studies in laboratories to suggest that the use of adult stem cells is a very promising field and may produce beneficial medical therapies to treat a variety of diseases,” the doctors said in the statement. They emphasized that there is a lack of consistency in the way stem cell facelift procedures are performed, and pointed out that many procedures are being advertised by physicians who are not board-certified for this type of treatment, and devices being sold for aesthetic stem cell treatments have not been approved for human use in the U.S.

In the report, the doctors encourage their peers to continue reporting clinic results and experimental research to peer-reviewed plastic surgery journals to both promote good science and to foster safety and best practices for stem cell use in aesthetic procedures. “Much more research needs to be conducted before any definitive statements can be made,” the report said. “[Until then,] stem cell based procedures should be performed in compliance with FDA regulatory guidelines.”

Dr. Rohrich said many of the advertisements claiming stem cells can aid in restoring facial and body youthfulness come from outside the U.S. “Further direct, approved clinical research is needed to validate those claims,” he said, “but the future is potentially bright for the use of adult stem cells in both plastic surgery and facial rejuvenation, as well as in medical procedures, such as restoring nerve and brain damage resulting from trauma or cancer, as well as reversing the severe effects of auto immune disease.”

To read the complete joint ASAPS/ASPS position statement on stem cell use in aesthetic surgery, including stem cell facelifts and natural breast augmentation, visit the ASPS, at their website.

About Rod J. Rohrich, M.D., F.A.C.S.

Dr. Rod J. Rohrich holds the Betty and Warren Woodward Chair in Plastic and Reconstructive Surgery at UT Southwestern Medical Center in Dallas, Texas. He also holds the UT Southwestern Medical Center Crystal Charity Ball Distinguished Chair in Plastic Surgery. He is a graduate of the Baylor College of Medicine with high honors, with residencies at the University of Michigan Medical Center and fellowships at the Massachusetts General Hospital/Harvard (hand/microsurgery) and Oxford University (pediatric plastic surgery). He has served as president of the American Society of Plastic Surgeons. He repeatedly has been selected by his peers as one of America's best doctors, and twice has received one of his profession's highest honors, the Plastic Surgery Educational Foundation Distinguished Service Award, which recognizes his contributions to education in his field. Dr. Rohrich participates in and has led numerous associations and councils for the advancement of plastic and reconstructive surgery. He is a native of North Dakota. He is married to Dr. Diane Gibby, also a plastic surgeon. They live in Texas with their two children.

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Rod J. Rohrich, M.D.
Rod J. Rohrich M.D.
(214) 821-9114
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Surgeons Urge Caution: Stem Cell Treatments Untested in Aesthetic Surgery

SAN DIEGO, Feb. 22, 2012 /PRNewswire/ – Sequenom, Inc. (NASDAQ: SQNM – News), a life sciences company providing innovative genetic analysis solutions, today announced that it has filed a motion for preliminary injunction against Aria Diagnostics (“Aria”) to stop Aria from making, using, selling or offering for sale, importing or exporting, infringing tests for detecting fetal chromosomal aneuploidy, such as Aria's Harmony Prenatal Test™, pending the ultimate resolution of the litigation.

Sequenom's request for preliminary injunction follows the lawsuit filed on January 24, 2012, in the United States District Court for the Southern District of California, which alleges that Aria infringes U.S. Patent No. 6,258,540 (“'540 patent”).  Sequenom is requesting that the district court quickly intervene to stop Aria Diagnostics' continued infringement of the '540 patent.

Sequenom Center for Molecular Medicine (Sequenom CMM) was the first to market a non-invasive prenatal diagnostics laboratory developed test (LDT) for chromosomal aneuploidy.  Sequenom CMM's MaterniT21™ PLUS LDT detects a genetic chromosomal anomaly known as Trisomy 21, the most common cause of Down syndrome, and also detects trisomies 18 and 13.  The test is available to physicians upon request in major metropolitan regions across the United States.

About Sequenom

Sequenom, Inc. (NASDAQ: SQNM – News) is a life sciences company committed to improving healthcare through revolutionary genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve discovery and clinical research, and molecular diagnostics markets. The company was founded in 1994 and is headquartered in San Diego, California. Sequenom maintains a Web site at http://www.sequenom.com to which Sequenom regularly posts copies of its press releases as well as additional information about Sequenom. Interested persons can subscribe on the Sequenom Web site to email alerts or RSS feeds that are sent automatically when Sequenom issues press releases, files its reports with the Securities and Exchange Commission or posts certain other information to the Web site.

About Sequenom Center for Molecular Medicine

Sequenom Center for Molecular Medicine (Sequenom CMM®) has two CAP accredited and CLIA-certified molecular diagnostics reference laboratories dedicated to the development and commercialization of laboratory developed test for prenatal and eye conditions and diseases.  Utilizing innovative proprietary technologies, Sequenom CMM provides test results that can be used as tools by clinicians in managing patient care.  Testing services are available only upon request to physicians.  Sequenom CMM works closely with key opinion leaders and experts in obstetrics, retinal care and genetics.  Sequenom CMM scientists use a variety of sophisticated and cutting-edge methodologies in the development and validation of tests.  Sequenom CMM is changing the landscape in genetic diagnostics. Visit http://www.scmmlab.com for more information on laboratory testing services.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the outcome or resolution of, or expectations regarding the motion for preliminary injunction, the ultimate resolution of the litigation, the Company's commitment to improving healthcare through revolutionary genetic analysis solutions, and Sequenom CMM's dedication to the development and commercialization of laboratory developed tests, and changing the landscape in genetic diagnostics, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including the risks and uncertainties associated with market demand for and acceptance and use by customers of products such as the MaterniT21 PLUS LDT, reliance upon the collaborative efforts of other parties, the Company's financial position, its ability to position itself for product launches and growth and develop and commercialize new technologies and products, particularly newer technologies such as noninvasive prenatal diagnostics, laboratory developed tests, and genetic analysis platforms, the Company's ability to manage its existing cash resources or raise additional cash resources, competition, intellectual property protection and intellectual property rights of others, government regulation particularly with respect to diagnostic products and laboratory developed tests, obtaining or maintaining regulatory approvals, litigation involving the Company, and other risks detailed from time to time in the Company's most recently filed Quarterly Report on Form 10-Q and Annual Report on Form 10-K for the year ended December 31, 2010, and other documents subsequently filed with or furnished to the Securities and Exchange Commission. These forward-looking statements are based on current information that may change and you are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.

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Sequenom, Inc. Files Motion for Preliminary Injunction Against Aria Diagnostics