|Quidel Wins FDA Clearance for RSV, HMPV; Stryker Receives FDA Warning Letter|
|By Staff and Wire Reports|
|Tuesday, 12 March 2013 19:08|
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Quidel Molecular RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV). The assay distinguishes between RSV and hMPV, two different viruses that cause respiratory infections with very similar symptoms.
The FDA's 510(k) clearance grants Quidel authorization to market its Quidel Molecular RSV + hMPV assay in the United States. The product launched in Europe shortly after receiving the CE Mark in March of 2012. "RSV and hMPV infections are relatively common diseases among children, and the symptoms can be indistinguishable from each other. Often, these infections can mimic flu-like illness, and can cause ambiguity in assigning a course of treatment," said Dr. Timothy Stenzel, M.D., Ph.D., chief scientific officer of Quidel. "For these reasons, a duplex test such as the RSV + hMPV assay can prove to be very valuable." This is one of several forthcoming assays from Quidel's expanding molecular diagnostics programs. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing molecular testing infrastructure, such as Life Technologies' Applied Biosystems(R) 7500 Fast DX thermocycler.
These reagents provide attractive features that include simple transport and refrigerated storage (no freezer required), convenient workflow, a short time to result, and other benefits that favorably affect diagnostic test outcome. Because they share a common extraction protocol, the RSV + hMPV assay can be batched alongside other Quidel Molecular assays, such as Influenza A+B PCR assay, in the same multi-well panel for customized multiplexing capability. "We are pleased to have received FDA clearance for another molecular diagnostic product," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "We intend to broaden our menu of molecular assays over the next several quarters, and in doing so, will provide our customers with a number of easy to use infectious disease tests that can be run on their existing thermocyclers."
The RSV + hMPV assay is Quidel's third molecular PCR assay to receive 510(k) clearance. Quidel previously received FDA clearance for Quidel Molecular assays for Influenza A+B and hMPV. Quidel also received FDA clearance for its C. difficile assay in the AmpliVue(R) format in December of 2012.
Stryker Corporation (NYSE: SYK) announced its Instruments division has received a warning letter from the U.S. Food and Drug Administration (FDA) related to observations made during a November 2012 inspection at its Portage, Michigan location.
The letter concerns quality system observations made during the inspection and cites Stryker for failing to notify the FDA of a product recall, and for marketing devices, including the Neptune Waste Management System, without a required 510(k) clearance. The letter acknowledged that Stryker Instruments has already submitted corrective action plans for the quality system and recall observations. The Company is fully cooperating with the FDA to resolve these matters in a comprehensive and timely manner.
Abattis Bioceuticals Corp (OTC PINK: ATTBF) (CNSX: FLU) today announced that it has provided $10,000 sponsorship for the cannabis (cannabis sp.) monograph and therapeutic compendium currently under development by the American Herbal Pharmacopoeia (AHP).
Advanced Cell Technology, Inc. (OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chief scientific officer Robert Lanza, M.D., is featured on the “TOP 50 Global Stem Cell Influencers” list from Terrapinn’s life sciences division, TotalBiopharma (“World Stem Cells & Regenerative Medicine Congress 2013”).
AmbiCom Holdings, Inc. (OTCQB: ABHI), a leading designer and developer of wireless products for the medical and automotive industries, and a distributor of innovative healthcare products, today announced that they have received a $380,000 order for their WL54-CF CompactFlash product to be used in a major company's glucose meter products.
Anavex Life Sciences Corp. ("Anavex") (OTCQB: AVXL) today announced more promising new data for ANAVEX 2-73, the company's lead drug candidate for Alzheimer's disease.
Bioheart Inc. (OTCQB: BHRT) announced that Bioheart's Chief Science Officer, Kristin Comella was named to the 50 most influential people on stem cells. The World Stem Cell Regenerative Medicine Congress asked the international stem cell community to compile a comprehensive list of the top 50.
BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S., today announced its financial results for the fourth quarter and full year ended December 31, 2012 and provided a corporate update.
BioTime, Inc. (NYSE MKT: BTX) today announced that Stephen C. Farrell has been appointed to its Board of Directors.
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, announced that President and CEO Steven A. Kriegsman and Vice President of Business Development David J. Haen will present at the 25th Annual ROTH Conference on Tuesday, March 19, 2013, at 4:00 p.m. Pacific time (7:00 p.m. Eastern time).
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Greg S. Lea., EnteroMedics' Senior Vice President, Chief Financial Officer and Chief Operating Officer, is scheduled to present at the 25th Annual Roth Capital Partners Conference on March 19, 2013 at 1:00 pm Pacific Time at the Ritz-Carlton in Laguna Niguel, CA.
iSatori, Inc. (OTCQB: IFIT), an emerging leader in the development and marketing of scientifically engineered nutritional supplements for healthier lifestyles, announced today it will be presenting at the 25th Annual ROTH Conference on March 19, 2013.
Immunotech Laboratories, Inc. (PINKSHEETS: IMMB) Immunotech Company Founder & Chief Scientific Officer Harry Zhabilov comments on the recent AIDS-HIV Baby Cure Treatments.
Iveda Solutions, Inc. (OTCBB: IVDA), the pioneer in cloud-based video services, and Farmacias de Similares®, the retail pharmacy industry leader based in Mexico City, have completed their pilot project and today declared it an unqualified success.
MMRGlobal, Inc. (OTCQB: MMRF) ("MMR") today announced that through its wholly owned subsidiary, MyMedicalRecords, Inc., the Company has received a Notice of Allowance from the Canadian Intellectual Property Office for Application Number 2,615,128 directed toward its "Method and System for Providing Online Medical Records."
NanoLogix Inc. (OTC: NNLX), an innovator in the accelerated detection, identification and antibiotic sensitivity determination of live bacteria, announces that final results of a 14 month study done by researchers at UTHSC-Houston have been published in a recent online edition of “ ” The results were also presented at the 33rd annual Society of Maternal Fetal Medicine meeting last month in San Francisco.
Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions and cell-based virology assays, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Quidel Molecular RSV + hMPV assay for the detection of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV).
Senomyx, Inc. (NASDAQ: SNMX), a leading company focused on using proprietary taste receptor technologies to discover, develop, and commercialize novel flavor ingredients for the food, beverage, and ingredient supply industries, announced today that Kent Snyder, the Company's Chief Executive Officer, and John Poyhonen, President & Chief Operating Officer, will present a corporate overview on Tuesday, March 19 at 5:30 p.m. Eastern Time (2:30 p.m. Pacific Time) during the 25th Annual ROTH Conference.
Synergetics USA, Inc. (NASDAQ: SURG), a medical device company that designs, manufactures, and markets innovative surgical devices for ophthalmic and neurosurgical applications, today reported results for the second quarter ended January 31, 2013.
VistaGen Therapeutics, Inc. (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue, predictive toxicology and drug metabolism assays, today announces that it will present key enhancements to LiverSafe3D™, its human liver cell-based bioassay system designed to predict liver toxicity and drug metabolism issues, in a poster presentation at the Society of Toxicology's 52nd Annual Meeting, the world's premier toxicology conference, in San Antonio, Texas, on March 12, 2013, at 11:00 am PDT.
Z Trim Holdings, Inc. (OTC Markets: ZTHO), a bio-technology company providing value-added ingredients to a variety of industries, today announced that its recently-concluded warrant exercise program resulted in the exercise of 1,756,088 warrants into 1,756,088 shares of ZTHO common stock.