Luminex Wins FDA Clearance for GPP; Lily's Amyvid Approved in EU Print E-mail
By Staff and Wire Reports   
Tuesday, 15 January 2013 20:27
Below is a look at some of the headlines for companies that made news in the healthcare sector on January 15, 2013.

Luminex Corporation (NASDAQ: LMNX)
announced it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay. The xTAG GPP assay can be an important clinical tool in the management of gastrointestinal infections, and is now available in the United States.

Diarrheal disease strikes more than two billion times globally each year and is a leading cause of child morbidity and mortality worldwide(1). In the United States alone, 99 million cases of GI infection occur annually, leading to over 250,000 hospitalizations(2) and 17,000 deaths(3), inflicting a significant toll on the healthcare system. Diagnosis of some causes of infectious gastroenteritis has traditionally required multiple tests across the microbiology, virology, and molecular laboratories for which results may not be available for several days.


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Eli Lilly and Company (NYSE: LLY)
and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, announced Amyvid (Florbetapir F 18 Injection) has received marketing authorization from the European Commission as a diagnostic radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease and other causes of cognitive impairment. Amyvid should be used in conjunction with a clinical evaluation.

Alzheimer's Disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging. Alzheimer's Disease and other causes of cognitive impairment share many overlapping symptoms, including deficiencies in memory, visuospatial ability, executive function, behavior, and language.  It is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not exhibit Alzheimer's Disease pathology upon autopsy.

"We believe that Amyvid fills an unmet need in the medical community, providing physicians with important information about the presence or absence of beta-amyloid plaques that can help identify the cause of their patients' cognitive symptoms," said Diane Bakaysa, Amyvid global brand development leader. "This is important because, if, based on negative Amyvid findings and clinical assessment, it is determined that Alzheimer's Disease is not the cause of cognitive impairment, a physician can avoid unnecessary or potentially harmful treatments associated with a misdiagnosis of Alzheimer's Disease."

Beginning in Q2 2013, Amyvid will be available in select areas within the European Union.



Also Tuesday:



Advanced BioMedical Technologies Inc. (OTCQB:ABMT)
, developer and manufacturer of orthopaedic internal fixation devices, is delighted to announce that the Company's Quality Management System (QMS) has been credited with ISO 13485:2003 certification.

AxoGen, Inc. (OTCBB: AXGN)
a leader in the science and commercialization of surgical solutions for peripheral nerve repair, today announced that it will be presenting at Noble Financial Capital Markets' Ninth Annual Equity Conference to be held at the Hard Rock Hotel in Hollywood, Florida.

CorMedix Inc. (NYSE MKT: CRMD)
, a pharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of cardiorenal disease, announced today that it has signed a commercial agreement with MKM Co-Pharma GmbH (http://mkm-europe.com/en/), a European sales, marketing and advertising company with extensive experience in the launch of cardiorenal products.

Covidien (NYSE:COV)
, a leading global provider of healthcare products, today announced the completion of enrollment in its DEFINITIVE AR (Anti-Restenosis) study.

Forest Laboratories, Inc. (NYSE: FRX)
, an international pharmaceutical manufacturer and marketer, today reported a GAAP loss per share of $0.58 in the third quarter of fiscal 2013 compared with income of $1.04 in the third quarter of fiscal 2012.

Galectin Therapeutics Inc. (NASDAQ: GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today announced the appointment of Rex Horton as Executive Director of Regulatory Affairs and Quality Assurance.

GE Healthcare (NYSE:GE)
today announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility.

Given Imaging (NASDAQ: GIVN)
today announced that it is ending its previously announced exploration of a possible sale or merger transaction as part of its evaluation of strategic options in order to maximize growth and enhance shareholder value.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today announced it will exhibit its Magellan™ Robotic System at the 25th Annual International Symposium on Endovascular Therapy (ISET), from January 19-23 at the Fontainebleau Miami Beach Hotel in Miami, FL.

Illumina, Inc. (NASDAQ:ILMN)
today announced that it will issue results for fourth quarter and fiscal year 2012 following the close of market on Monday, January 28, 2013.

Illumina, Inc. (NASDAQ: ILMN)
today announced two new grant recipients of its Agricultural Greater Good Initiative at the 21st International Plant and Animal Genome Conference. The recipients, International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) and Biosciences Eastern and Central Africa – International Livestock Research Institute Hub (BecA-ILRI Hub), are pioneering applications of Illumina technologies to increase crop yields and reduce poverty and hunger.

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD)
today provided an update on its fourth quarter 2012 and recent business activities.

Luminex Corporation (NASDAQ: LMNX)
announced today that it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first comprehensive molecular diagnostic assay that tests for greater than 90% of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay.

NanoViricides, Inc. (OTC BB: NNVC)
(the "Company") provides an update on its influenza program. The Company states that in a highly lethal animal model against an H3N2 Influenza virus strain, very similar to the current dominant influenza strain, the Company’s oral anti-influenza drug candidate has shown significantly superior efficacy to Tamiflu® (oseltamivir).

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB)
, a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced the completion of a study of its novel radiopharmaceutical NAV4694 as a biomarker for visual detection and quantification of cerebral β-amyloid in diagnosing Alzheimer’s disease (AD).

Neptune Technologies & Bioresources (NASDAQ: NEPT)
announced they will hold a conference call on Thursday, January 17th at 4:30 EST.

Nu Skin Enterprises, Inc. (NYSE: NUS)
today announced that Chief Financial Officer, Ritch Wood, will present at the ICR XChange Conference in Miami on Thursday, Jan. 17, 2013.

Omnicell, Inc. (NASDAQ: OMCL)
, a leading provider of medication and supply management solutions and analytics software for healthcare facilities, today announced that Springhill Medical Center selected Omnicell as its exclusive provider for medication management solutions throughout its 252-bed hospital in Mobile, AL.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced an underwritten public offering of 4,400,000 shares of its common stock.

Opexa Therapeutics, Inc. (NASDAQ: OPXA)
, a company developing Tcelna™, a novel T-cell therapy for multiple sclerosis (MS), today announced that it has received a letter from The NASDAQ Stock Market LLC notifying the Company that it has regained full compliance with the NASDAQ Capital Market's minimum bid price continued listing requirement.

PuraMed BioScience®, Inc, (OTCBB: PMBS)
announces that its over-the-counter, homeopathic migraine pain reliever formulation, LipiGesic®M, has received a Notice of Allowance for its patent application from the United States Patent and Trademark Office.

Quture International, Inc. (OTCQB: QUTR)
announced today that they will conduct a shareholder conference call on Wednesday, January 23, 2013, at 4:15 p.m. Eastern Standard Time to provide a management update and strategic marketing and sales plan for 2013.

ReliaBrand Inc. (OTCBB:RLIA)
announced today the introduction of the "NxGen® Medi-Nurser™", the newest innovation from their Adiri® brand of infant feeding products.

Simulations Plus, Inc. (NASDAQ: SLP)
, a leading provider of simulation and modeling software for pharmaceutical discovery and development, today reported financial results for its first quarter of fiscal year 2013 ended November 30, 2012 (1QFY13).

Stellar Biotechnologies, Inc. (OTCQB: SBOTF) (TSX VENTURE: KLH)
, the world leader in sustainable manufacture of GMP-grade Keyhole Limpet Hemocyanin (KLH), is very pleased to announce that it was listed for trading in U.S. yesterday on the OTCQB Market under the symbol SBOTF.

WPCS International Incorporated (NASDAQ: WPCS)
, a leader in design-build engineering services for communications infrastructure, has announced that it has received approximately $4 million in new projects.



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