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Company allowed to patent parthenogenetic stem cells in Europe.
CARLSBAD, CA–(Marketwired – December 18, 2014) – International Stem Cell Corporation ( OTCQB : ISCO ), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that the Court of Justice of the European Union (CJEU), the European Union’s highest court, has ruled in favor of the Company and that the Company’s core technology patent applications are not covered by the prohibition on patenting embryonic stem cells. This ruling confirms the opinion of the Advocate General published in July 2014.
Stem cell-derived tissue reverses diabetes in humanized mice; ViaCyte helps study.
Published Study Shows Panorama™ NIPT Is Validated To Screen For Microdeletion Syndromes At 9 Weeks Of Pregnancy
SAN CARLOS, Calif., Dec. 18, 2014 /PRNewswire/ – Natera, Inc., a leader in non-invasive genetic testing, today announced the publication of its validation study showing that the Panorama™ non-invasive prenatal test (NIPT) is highly accurate in screening for the most common and severe microdeletion syndromes. These tiny missing pieces of DNA at the sub-chromosomal level can have serious health implications depending on the location of the deletion. The study is now available online and will be published in the March 2015 issue of American Journal of Obstetrics and Gynecology.
According to the study of 469 cases including 111 positive controls, Panorama demonstrated analytical sensitivity greater than 97% and false positive rate less than 1% for each of five microdeletion conditions tested. Based on these results, the study’s authors concluded that “offering NIPT-based microdeletion screening to the general [pregnant] population may be appropriate.”
Microdeletions are tiny missing pieces of DNA at the sub-chromosomal level that can have serious health implications. The study noted that “clinically relevant microdeletions and duplications occur in >1% of pregnancies regardless of maternal age… these genomic alterations occur more frequently than those presently screened for, such as Down syndrome.” Unlike Down syndrome, where risk increases with maternal age, microdeletion syndromes carry equal risk across all maternal ages. The five microdeletions tested by Panorama have a combined incidence of approximately 1 out of every 1,000 births, making them together more common than Down syndrome in women under 28 years of age.
Panorama screens for the following microdeletions: 22q11.2 deletion syndrome (also known as DiGeorge syndrome), 1p36 deletion, Angelman, Cri-du-chat and Prader-Willi syndromes. Individually, 22q11.2 deletion syndrome has the highest incidence on Panorama’s microdeletion panel at approximately 1 in every 2,000 births, which makes it at least as common as cystic fibrosis. Natera has partnered with the 22q11.2 International Foundation to raise awareness about this condition and the importance of early diagnosis.
Finally, the study noted that “widespread implementation will require education of care givers and appropriate counseling of patients.” Natera has committed significant resources to medical education and patient counseling tools, emphasizing that Panorama is an advanced screening tool which identifies patients at increased risk, but it is not a diagnostic.
The study, entitled Expanding the scope of non-invasive prenatal testing: Detection of fetal microdeletion syndromes can be found online at www.ajog.org.
About the Panorama™ Prenatal Screening Test
Panorama is a safe and highly accurate non-invasive prenatal test (NIPT) that screens for common genetic diseases. Panorama is the only NIPT that uses Single-Nucleotide Polymorphisms (SNPs) to differentiate between and analyze both the maternal and fetal DNA. Through a simple blood draw that can be performed in a doctor’s office, Panorama can screen for chromosomal abnormalities as early as 9 weeks gestation. Additionally, the test can determine the baby’s gender, and results are provided to the clinician usually within 7-10 calendar days. Panorama also includes expanded screening for common and severe microdeletion syndromes (where a small piece of a chromosome is missing).
Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to help families diagnose and manage genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif., currently offering a host of preconception and prenatal genetic testing services primarily to OBGYN physicians and in-vitro fertilization centers. In 2013, the company launched Panorama™, a safe, simple test for pregnant women that screens for the most common chromosomal anomalies in a fetus as early as nine weeks of gestation. Tests developed by Natera have not been cleared or approved by the U.S. Food and Drug Administration (FDA). For more information, visit www.natera.com.
ContactsGOLD PR for NateraJill Edgeworth, email@example.com
Natera, Inc.Michael Hromadik, 858-442-2215 firstname.lastname@example.org
Photo – http://photos.prnewswire.com/prnh/20141218/165184LOGO
SOURCE Natera, Inc.
SAN DIEGO, Dec. 18, 2014 /PRNewswire/ — HUYA Bioscience International, a leader in accelerating the global development of China’s pharmaceutical innovations, today announced a strategic collaboration agreement with China Wuqing Development Area, a state-level economic and technological development area located between Beijing and Tianjin. The collaboration will focus on promoting biomedical innovations from companies located in the Area.
HUYA is one of the first companies to have recognized China’s potential for helping to meet the global need for new preclinical and clinical stage compounds. The company is focused on speeding the development and value creation for China-sourced novel biopharmaceutical compounds in worldwide markets. HUYA has established a series of collaborations with leading universities and research institutes throughout China and has pioneered in-licensing of both preclinical and clinical stage compounds from the country.
China Wuqing Development Area is a national level economic-technological development zone and a high technology industrial park approved by China’s State Council. Situated between the downtown areas of Beijing and Tianjin, two of China’s four municipalities directly under the central government, the Area has attracted over 1400 enterprises from more than 50 countries and amassed investments totaling 120 billion RMB (19.5 billion USD). Biomedicine is a leading industry in the Area and a focus of its two new sections–the EU-Industry Park and the Jingjin Gaocun Science and Technology Innovation Park.
The alliance combines the expertise of both HUYA and China Wuqing Development Area to promote biomedical innovations originating in Wuqing with global market potential. Chinese pharmaceutical companies in the Area will be able to leverage HUYA’s international pharmaceutical knowledge and networks, and consult with HUYA’s team of experts in drug development and commercialization. HUYA will have the right of priority review to evaluate certain research and development projects of these companies and provide advice and consultation as needed. HUYA will also assist the Park in introducing business and investment opportunities.
“This is an exciting start of HUYA’s collaboration with prestigious China Wuqing Development Area to accelerate the development and globalization of innovative biomedical products from Wuqing,” said Clement Gingras, HUYA’s Chief Technology Officer and Chief Operating Officer Asia. “With both sides’ complementing strengths, this partnership will bring value to both parties as well as other organizations in the Area.”
Jibin Wang, Deputy General Manager of the Wuqing Development Area General Corporation, the management entity of the Area, was also very upbeat about the alliance. “Our unique advantages of location and abundant resources for the biomedical industry will create synergies with HUYA’s international insight and expertise in innovative drug development,” he said. “We look forward to productive collaboration over the coming years.”
About HUYA Bioscience International HUYA Bioscience International is a leader in enabling and accelerating the global development of novel biopharmaceutical product opportunities originating in China. HUYA has established extensive collaborations with Chinese biopharmaceutical academic and commercial organizations to speed development and value creation in worldwide markets for China-sourced product candidates. With the largest Chinese compound portfolio covering all therapeutic areas, HUYA has emerged as the partner-of-choice for building and maximizing the value for biopharmaceutical innovation in China. HUYA has offices in the US, the UK, and Japan, and in eight strategic locations across China, with joint headquarters in San Diego and Shanghai. HUYA’s team is practiced in leading pharmaceuticals and medical devices through FDA and PMDA submission and approval to commercialization. www.huyabio.com
About China Wuqing Development Area China Wuqing Development Area, approved by the State Council in 1991, is both a state-level economic and technological development area and a state-level hi-tech industrial park with a total 93 km2 planned area. It is located in the Wuqing District of Tianjin near Beijing, thus known as the “corridor of Beijing and Tianjin.” With 1.1 million residents and 1574 km2 area, Wuqing is one of the fastest growing regions in terms of economic development in Tianjin. Besides its favorable location with convenient transportation links, the Area’s advantages also include abundant human resources, highly efficient supporting facilities and administrative services, and preferential policies for investment projects. In addition to biomedicine, the other five leading industries are electronic information, new material, machinery manufacturing, automobile and spare parts, and new energy. http://en.tjuda.com/
Contact: Clement Gingras CTO and COO Asia HUYA Bioscience International +1.858.798.8800 email@example.com
Yung-Chih Wang, Ph.D., MBA VP, Corporate Development China HUYA Bioscience International +1.858.798.8818 firstname.lastname@example.org
SOURCE HUYA Bioscience International
ViaCyte, Inc. (Formerly Known as Novocell, Inc.) Release: Study Further Validates Cell Therapy Approach To Reverse Type 1 Diabetes
SAN DIEGO, Dec. 18, 2014 /PRNewswire/ — ViaCyte, Inc. announced today a preclinical study published online in Cell Stem Cell that describes a novel approach to replace the insulin-producing cells that are lost in type 1 diabetes. The approach utilizes pancreatic precursor cells derived from human embryonic…
Quidel Receives Simultaneous FDA Clearance And CLIA Waiver For Its Sofia(R) Strep A Fluorescent Immunoassay (FIA) Via The FDA’s New Dual Submission ProgramSAN DIEGO, CA–(Marketwired – Dec 17, 2014) – Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today…
SAN DIEGO, Dec. 18, 2014 /PRNewswire/ — HUYA Bioscience International, a leader in accelerating the global development of China’s pharmaceutical innovations, today announced a strategic collaboration agreement with China Wuqing Development Area, a state-level economic and technological…
SAN DIEGO, Dec. 17, 2014 /PRNewswire-iReach/ –eLux Medical, Inc., developer of NanoLipo, a novel nanomedicine approach to liposuction, is pleased to announce that Peter C. Farrell, PhD, DSc, AM, has joined its Business Advisory Board. Dr. Farrellis founder and chairman of the…
Quidel Receives Simultaneous FDA Clearance and CLIA Waiver for Its Sofia(R) Strep A+ Fluorescent Immunoassay (FIA) via the FDA’s New Dual Submission Program
SAN DIEGO, CA–(Marketwired – Dec 17, 2014) – Quidel Corporation ( NASDAQ : QDEL ), a provider of rapid diagnostic testing solutions, cell-based virology assays and molecular diagnostic systems, announced today that it has received marketing clearance and CLIA waiver by the United States Food and Drug Administration (FDA) for its Sofia Strep A+ Fluorescent Immunoassay (FIA) for the rapid detection of infections by Group A Streptococcus bacteria. These bacteria are the most common cause of bacterial pharyngitis and can also cause rheumatic fever and other potentially serious illnesses.