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Sequenom, Inc. Announces Date Of Third Quarter 2014 Financial Results And Conference Call

October 21, 2014 – 4:00 am | Edit Post

SAN DIEGO, Oct. 21, 2014 /PRNewswire/ – Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced it will report financial results for the third quarter 2014 after closing of the NASDAQ Global Market on Tuesday, November 4, 2014.  

A conference call hosted by William Welch, CEO, and other members of senior management will take place on Tuesday, November 4, 2014, at 5:00 p.m. EDT (2:00 p.m. PDT) and will be webcast live on the Sequenom Website.

To access the live teleconference call, dial 877-883-0383 in the U.S. and Canada, and 412-902-6506 for other international callers. Please use code 0747050. For interested parties unable to listen to the live conference call, a replay will be available through Friday, December 5, 2014. The replay will be accessible by dialing 877-344-7529 or 412-317-0088 international toll or Canada toll free at 855-669-9658, and entering the conference number 10054723.

The conference call webcast is also accessible through the “Invest” section of the Sequenom Website at www.sequenom.com/invest. An online replay will be available following the initial broadcast until Friday, December 5, 2014. 

About Sequenom

Sequenom, Inc. (NASDAQ: SQNM) is a life sciences company committed to improving health care through revolutionary genomic and genetic analysis solutions. Sequenom develops innovative technology, products and diagnostic tests that target and serve molecular diagnostic markets. Web site: www.sequenom.com.  

Logo – http://photos.prnewswire.com/prnh/20040415/SQNMLOGO
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/sequenom-inc-announces-date-of-third-quarter-2014-financial-results-and-conference-call-848332976.html
SOURCE Sequenom, Inc.

Ivera Medical Successfully Completes FDA Inspection

October 21, 2014 – 2:00 am | Edit Post

SAN DIEGO, CA–(Marketwired – Oct 21, 2014) – Ivera Medical Corporation is pleased to report that it successfully completed several days of an exhaustive and intensive review by the Food and Drug Administration (FDA) of Ivera’s manufacturing practices, quality control and regulatory filings. At the conclusion of the inspection, which was prompted by a complaint filed by a competitor (Catheter Connections), the inspector found that no corrective actions were needed. Ivera recently received a copy of the inspection report from the local FDA District Office confirming that the inspection is now considered officially closed.

Study on Lassa fever virus gets $6.6M

October 20, 2014 – 7:28 pm | Edit Post

Scripps Research-led team to study Lassa fever virus under a $6.6 million grant.

Cypher Genomics Identifies and Verifies Genetic Cause of Rare Disease, Epileptic Encephalopathy

October 20, 2014 – 11:00 am | Edit Post

SAN DIEGO, Oct. 20, 2014 /PRNewswire/ – Cypher Genomics, Inc., the genome informatics company, announced today the identification of de novo KCNB1 missense mutations as a novel genetic cause of severe epileptic encephalopathy. Cypher’s co-founder and Chief Scientific Officer Ali Torkamani, Ph.D. reviewed the data today at a platform presentation at the ASHG 2014 meeting being held October 18 to 22 in San Diego.  This study highlights how Cypher’s MantisTM technology, which incorporates commercial access to the Scripps Wellderly Cohort as a genome reference population, can rapidly and accurately identify novel causes of rare diseases.  

“Rare diseases disproportionately affect children, and families are left with unanswered questions and monumental medical bills in seeking a diagnosis,” said Ashley Van Zeeland, Ph.D., co-founder and Chief Executive Officer of Cypher Genomics. “Accurate genome analysis and interpretation has historically been a time consuming and manual process. We developed Mantis to address this unmet need in order to rapidly and accurately find the underlying genetic causes of disease.”

The data presented today describes an 8-year-old female patient who presented with a sporadic severe partial seizure disorder and a complex and unusual medical history of neurologic disorder, which did not fit any diagnostic category. A family-based genome sequencing study was performed including whole genome sequencing and whole exome sequencing.

Researchers utilized Mantis to identify a de novo missense mutation in KCNB1 that encodes the KV2.1 voltage-gated potassium channel as the potential cause of the patient’s disorder. This was further verified and confirmed by functional studies showing a deleterious effect of the mutation on KV2.1 function leading to a loss of ion selectivity and gain of a depolarizing inward cation conductance. Subsequently, two additional patients with epileptic encephalopathy and de novo KCNB1 missense mutations that result in a similar pattern of KV2.1 dysfunction were identified.

“While each rare disease only affects a small group of patients, millions of patients around the world are affected by a rare disease, and many never receive a definitive diagnosis,” said Dr. Van Zeeland. “Cypher’s Mantis technology was developed to help clinicians give patients and families an answer to what is causing their disease and what treatments may help.”

ASHG 2014

For researchers and clinicians, Cypher is launching a limited-time, trial access program, called Mantis 5-for-5. To learn more and sign up, visit Cypher at ASHG 2014 at booth #1525 or click here.  In addition, Cypher has a second platform presentation tomorrow.  Abstract 317: Frequency of “ACMG-56″ Variants in Whole Genomes of Healthy Elderly will be presented by Lauren Ariniello on Tuesday, October 21 from 10:30 am to 12:30 pm in Room 29, upper level of the San Diego Convention Center.

About Cypher Genomics

Cypher Genomics is a leading genome informatics company offering a highly accurate, rapid and robust interpretation software solution for users of human genome sequencing. The proprietary, automated genomic interpretation platform allows clinical laboratories to tune Cypher Genomics’ market leading sensitivity and specificity profiles to develop molecular tests for diagnostic and prognostic use and pharmaceutical companies to discover biomarkers from whole genome sequence data in sample sizes typical of early stage drug development studies. Through MantisTM, the genome interpretation software as a service offering, and CoralTM, a biomarker discovery service, Cypher Genomics can improve health care and reduce costs by facilitating improved diagnostic accuracy and earlier interventions, optimizing therapeutic approaches and reducing adverse drug reactions. Cypher Genomics is located in San Diego, California.

For more information about Cypher Genomics, visit www.cyphergenomics.com and connect with us on Twitter @cyphergenomics.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cypher-genomics-identifies-and-verifies-genetic-cause-of-rare-disease-epileptic-encephalopathy-761698313.html
SOURCE Cypher Genomics, Inc.

Promise Put to the Test

October 20, 2014 – 10:43 am | Edit Post

UC San Diego Sanford Stem Cell Clinical Center is pushing therapeutic stem cell-based science out of the laboratory and closer to real-world medical applications. The unprecedented trials involve potential therapies for spinal cord injuries, Type 1 diabetes and chronic lymphocytic leukemia.

Global Alliance for Genomics and Health Members Meet to Advance Genomic Data Sharing

October 20, 2014 – 9:42 am | Edit Post

BOSTON and CAMBRIDGE, Mass., Oct. 20, 2014 /PRNewswire/ – The Global Alliance for Genomics and Health convened its second major meeting of 2014 on Saturday, bringing together more than 250 international leaders to collaborate on the development of innovative solutions to accelerate sharing of genomic and clinical data. At their plenary meeting, held in San Diego, California, Alliance members shared progress to date and discussed next steps for the effort.

The Global Alliance is an international coalition of over 140 member organizations dedicated to improving human health by maximizing the potential of genomic medicine. The group’s diverse membership includes world-leading institutions in healthcare, research, patient and disease advocacy, life science, and information technology who are working together on open interfaces and catalytic projects to enable effective and responsible data sharing and guide this quickly evolving field. The Alliance is supported by a small number of Host Institutions, including the Broad Institute of Harvard and MIT.

“The Global Alliance is focused on developing approaches that will enable sharing of genomic and clinical data. In just over one year, we have established a vibrant international effort to accelerate progress in harmonizing regulations and ethics, methods for sharing genomic and clinical data, and approaches to privacy and security,” said David Altshuler, Chair of the Global Alliance Steering Committee and Deputy Director of the Broad Institute of Harvard and MIT. “Our members are dedicated to producing work products and to undertaking data sharing projects that break down barriers and increase learning from data.”

Following its formation in 2013, the Global Alliance has sparked collaboration that involves hundreds of stakeholders globally and released several major products, including a regulatory Framework to guide the responsible sharing of genomic and health-related data and a GA4GH Genomics API to streamline specific technical aspects of data sharing and allow for more seamless exchange globally.

The Alliance’s plenary meeting coincided with the Annual Meeting of the American Society of Human Genetics (ASHG), and the Global Alliance will also hold an information session for ASHG attendees on Monday, October 20.

“Our field is rapidly evolving, and the Global Alliance continues to be at the forefront of efforts to create harmonized approaches and catalyze projects that drive research forward,” said Cynthia Morton, President of ASHG. “We believe that this international partnership will be highly effective in unlocking potential advancements in human health, and we’re excited to contribute substantially to the capabilities, capacity, and progress of the Global Alliance in the coming years.”

In addition to highlighting best practices and developing targeted methods to advance responsible data sharing, Alliance members are advancing data sharing projects to demonstrate value and promote real-world learning. These include a global BRCA Challenge, which aims to learn from genotype and phenotype data from many studies without compromising patient privacy, thereby increasing the ability to interpret BRCA1 and BRCA2-related cancer risks. Another example is the Matchmaker Exchange project, designed to help patients and doctors grappling with rare genotypes and phenotypes to overcome siloed data, find one another through a federated architecture, and work together.

“The Global Alliance’s work will allow researchers and clinicians to tap into the power of data networks on a global scale,” said Keith Yamamoto, Vice Chancellor for Research and Executive Vice Dean of the School of Medicine at the University of California, San Francisco (UCSF), who gave opening remarks at the meeting. “The Alliance is expanding the boundaries of data sharing to improve human health, while promoting meaningful standards. The field needs this effort as we move forward and work to harness the transformational potential of biomedicine.”

On September 18, 2014 the Global Alliance adopted a Constitution to formally guide and govern the structure and membership criteria of the organization. In less than a month, more than 135 organizations of the over 200 that had originally signed a Letter of Intent have already transitioned to full members of the Global Alliance for Genomics and Health. It is expected that many more organizations and individuals will do so in the coming months. 

“At a time of rapid change, the Global Alliance is coming together for our second plenary meeting in San Diego to look ahead to our next steps and achievable goals in the next few years,” said Martin Bobrow, Vice Chair of the Global Alliance Steering Committee and Emeritus Professor of Medical Genetics at the University of Cambridge. “As was evident at this critical meeting, the Global Alliance will continue to promote international collaboration to identify, develop, and promulgate innovative approaches to data sharing and to support efforts already underway.”

The Global Alliance for Genomics and Health is an international, non-profit alliance formed to help accelerate the potential of genomic medicine to advance human health. The Alliance is currently hosted by the Broad Institute of Harvard and MIT, the Ontario Institute of Cancer Research, and the Wellcome Trust Sanger Institute. Bringing together over 140 leading organizations working in healthcare, research, disease and patient advocacy, life science, and information technology, partners in the Global Alliance are working together to create a common framework of standards and harmonized approaches to enable the responsible, voluntary, and secure sharing of genomic and clinical data. Learn more at: http://genomicsandhealth.org.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-alliance-for-genomics-and-health-members-meet-to-advance-genomic-data-sharing-359076689.html
SOURCE Global Alliance for Genomics and Health; Broad Institute

San Diego’s Third-Quarter Venture Activity on Par, and Top 10 Deals

October 20, 2014 – 5:34 am | Edit Post

Venture capital funding for startups in the San Diego area ticked up slightly during the third quarter that ended Sept. 30, with $238.5 million invested in 27 deals, according to data from the…

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Nano-Bio Manufacturing Consortium Selects Project Proposed by Arizona Center for Integrative Medicine to Optimize Human Performance Monitoring Techniques

October 20, 2014 – 5:30 am | Edit Post

SAN JOSE, Calif., Oct. 20, 2014 /PRNewswire/ — The Nano-Bio Manufacturing Consortium (NBMC), an industry-academia partnership with the United States Air Force Research Laboratory (AFRL), has chosen a project proposed by the Arizona Center for Integrative Medicine (AzCIM) at the University of Arizona College of Medicine – Tucson, to receive research funding.  The AzCIM project’s goal is to assess different sweat collection methods and devices for their ability to collect different volumes of sweat under a variety of human-body conditions, the results of which will help determine the best method for integrating into a wearable sensor system.  Funding for the one year program will total $200,000. 

As part of the project, at least one analytical method, including offline immunoassay or mass spectrometry-based, will be developed to determine the levels of each of several AFRL-preferred biomarkers in sweat samples collected from multiple skin regions. Two molecules, one small and one large protein, will be selected for analysis from the following biomarkers: Orexin-A (impacts  arousal and alertness); Neuropeptide Y (associated functions include stress reduction and lowering pain perception); Interleukin 6 (stimulates immune response); cortisol (released in response to stress); and Oxytocin (associated with various reproductive and bonding functions).

Because the biomarker levels may be low and thus more difficult to detect by some analytical techniques, different methods for sweat concentration and purification will also be assessed. The various sweat collection methods will then be assessed for the desired volume, under a variety of conditions, including whole-body hyperthermia.

Esther Sternberg, M.D., project technical lead and AzCIM director of research, noted, “Participating in this program is a natural extension of AzCIM’s research focus on mind-body science. Brain-immune connections are critical in decision-making and alertness, which can be greatly compromised by stress and fatigue, particularly for military personnel and others in high-pressure situations.  Trauma related immune activation can also directly compromise performance and brain function. Devising a way to accurately detect these parameters in real time before problems set in, is essential to helping ensure physical and mental wellness for these individuals.”

In addition to Dr. Sternberg, the AzCIM project team includes Min Jia, Ph.D., AzCIM research assistant professor, as alternate technical representative. The AFRL program manager for the project is Laura Rea.

“Reproducibly collecting and analyzing sweat in a range of conditions and scenarios is a central challenge of enabling human performance monitoring,” said Dr. Benjamin Leever, AFRL Lead for Additive Manufacturing of Functional Materials.  “This capability could significantly impact a large variety of Air Force missions.”

“AzCIM and Dr. Sternberg possess a sterling reputation for successful collaboration on initiatives that investigate the relationship between wellness and one’s environment,” said NBMC CEO Malcolm Thompson. “Ensuring that we are looking at the right biomarkers and collecting samples in the most optimal manner provides a crucial foundation for helping achieve NBMC’s objective to develop a technology platform for a lightweight, low-cost, wearable biosensor patch.”

About NBMC The Nano-Bio Manufacturing Consortium (NBMC) was formed by the FlexTech Alliance, in collaboration with a nationwide group of partners, for the U.S. Air Force Research Laboratory (AFRL). The mission of the partnership is to bring together leading scientists, engineers, and business development professionals from industry and universities in order to work collaboratively in a consortium, and to mature an integrated suite of nano-bio manufacturing technologies to transition to industrial manufacturing. Initial activities focus on AFRL/ DoD priorities, e.g., physiological readiness and human performance monitoring. Specifically, NBMC matures nano-bio manufacturing technologies to create an integrated suite of reconfigurable and digitized fabrication methods that are compatible with biological and nanoparticle materials and to transition thin film, mechanically compliant device concepts through a foundry-like manufacturing flow. The long-term vision is that NBMC operates at the confluence of four core emerging disciplines: nanotechnology, biotechnology, advanced (additive) manufacturing, and flexible electronics. The convergence of these disparate fields enables advanced sensor architectures for real-time, remote physiological and health/medical monitoring.
SOURCE Nano-Bio Manufacturing Consortium

Halozyme Therapeutics, Inc. Receives FDA Approval For Additional Manufacturing Facilities For Hylenex?? Recombinant

October 20, 2014 – 5:00 am | Edit Post

SAN DIEGO, Oct. 20, 2014 /PRNewswire/ –Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that the U.S. Food and Drug Administration (FDA) has approved new contract manufacturing facilities used in the production of Hylenexrecombinant (hyaluronidase human injection). The FDA approved…

Lpath, Inc. Granted Key European Patent Related To iSONEP And ASONEP Programs

October 20, 2014 – 5:00 am | Edit Post

SAN DIEGO, Oct. 20, 2014 /PRNewswire/ — Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics,received official notification from the European Patent Office that the company has been granted another key patent supporting its iSONEP and ASONEP programs. This newly issued…