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FDA grants EUA for Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay in CLIA high complexity laboratories

Longhorn Vaccines & Diagnostics today announced it has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ in CLIA high complexity laboratories. . The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ is a ready-use assay that requires no mixing prior to use and has been authorized for use on the ABI 7500.

24 Feb 2010

Cantimer, Advanced Instruments announce license and product development agreement

Cantimer, Inc., and Advanced Instruments, Inc. today jointly announced that the two companies had signed a license and product development agreement. Under the terms of the license agreement, Advanced Instruments received an exclusive license to Cantimer's unique sensor technology for select applications in the biotech market.

23 Feb 2010

Prevention of preterm birth and stillbirth: Global collaborative efforts needed

A new report identifies the enormous global impact of preterm birth and stillbirth—and what can be done to decrease it. Globally, an estimated 13 million babies are born preterm each year. Newborn deaths now account for more than 42 percent of mortality in children under the age of five, a rise from 37 percent in the year 2000. Additionally, an estimated 3.2 million are stillborn each year, and many of these losses are linked to maternal deaths.

23 Feb 2010

Lilly, Merck, Pfizer collaborate to accelerate research on commonly-diagnosed cancer

Eli Lilly and Company, Merck (also known as Merck Sharp & Dohme (MSD) outside the USA and Canada), and Pfizer Inc. today announced the formation of the Asian Cancer Research Group, Inc., an independent, not-for-profit company established to accelerate research and ultimately improve treatment for patients affected with the most commonly-diagnosed cancers in Asia.

23 Feb 2010

Global report identifies causes leading to preterm births and stillbirths

More research and attention are urgently needed to understand and reduce the incidence of preterm births and stillbirths worldwide, according to experts from the Global Alliance to Prevent Prematurity and Stillbirth (GAPPS).

23 Feb 2010

Hologic enters into settlement agreement with Ethicon Endo-Surgery

Hologic, Inc., a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced it has entered into a settlement agreement with Ethicon Endo-Surgery, Inc., a Johnson & Johnson company.

From Hologic, Inc. 20 Feb 2010

Genoptix signs multi-year licensing agreement with HistoRx for AQUA technology

Genoptix, Inc., a specialized laboratory service provider, and HistoRx, Inc. (privately held), a diagnostics company, today announced a multi-year licensing agreement for AQUA® technology and several diagnostic assays based on it.

19 Feb 2010

Micro Imaging Technology becomes Micro Identification Technologies

Micro Imaging Technology, Inc. today announced that it has changed is company name to Micro Identification Technologies to better reflect the extensive capabilities of its ID technology software.

19 Feb 2010

Roseville ROC commences cancer treatment with Elekta VMAT

The first treatments with Elekta Volumetric Modulated Arc Therapy (VMAT) began November 17, 2009 at Roseville Radiation Oncology Center (ROC) at Radiological Associates of Sacramento (RAS). RAS, a large private medical group, includes diagnostics as well as therapy in its centers. ROC treats 30-35 patients per day, mainly with prostate and breast lesions.

From Elekta 19 Feb 2010

New report shows dramatic rise in medical technology, pharmaceuticals and healthcare costs

Management of Emerging Healthcare Solutions, Inc. (Pinksheets: EHSI) stated that they were encouraged by a new report that parallels the company’s conclusions about the new potential for business in the current healthcare marketplace.

19 Feb 2010

AutoGenomics awarded ISO 13485 certification for quality management system

AutoGenomics, a leader in providing automated, molecular testing solutions announced today that the organization has been awarded the ISO 13485 certification in recognition of its outstanding quality management system throughout the organization. TUV SUD America Inc. was the Certification Body.

18 Feb 2010

Single microRNA exhibits potential to forecast outcomes of MPM

Rosetta Genomics, Ltd., a leading developer and provider of microRNA-based molecular diagnostics, announced today that the results of a joint study with the NYU Langone Medical Center were published online on February 16th, 2010, and are set to be published in the March 1st issue of the American Association for Cancer Research’s journal, Cancer Research.

18 Feb 2010

Norwegian government task force suggests formation of single company to commercialise biomaterial assets

Having studied the ethical, judicial and political arguments, the Norwegian government task force has suggested that a single nationwide company should be formed to commercialise biomaterials assets from the country’s various sources. The task force has also recommended HUNT Biosciences be a model for the national company.

18 Feb 2010

HPV DNA testing vital in identification of cervical cancer

Roche Molecular Systems, Inc. announced today that preliminary data from its ATHENA (Addressing THE Need for Advanced HPV Diagnostics) trial support the importance of screening for human papillomavirus (HPV) genotypes that put women at highest risk for developing cervical cancer. ATHENA is a prospective, double-blind, multi-centered, 47,000-patient, U.S.-registration trial designed to demonstrate the effectiveness of HPV detection as part of a cervical cancer screening program.

18 Feb 2010

Roche Molecular Systems, Merck Sharp & Dohme announce cancer therapeutics collaboration

Roche Molecular Systems, Inc. announced today a research collaboration with Merck Sharp & Dohme Corp. (a subsidiary of Merck & Co., Inc.) providing Merck access to Roche's developmental microarray-based AmpliChip p53 Test, which is designed to detect mutations in the tumor suppressor gene p53. By identifying cancers that harbor a dysfunctional p53 gene, the companies aim to achieve better treatment outcomes in cancer patients by determining which patients are most likely to respond to certain investigational therapeutic candidates.

18 Feb 2010

PositiveID acquires intellectual property rights and assets of Easy Check Medical Diagnostics

PositiveID Corporation announced today that it has acquired intellectual property rights and assets of Easy Check Medical Diagnostics, LLC, to expand its portfolio of non-invasive glucose-level testing products and diabetes management tools under development. Easy Check has two primary products under development: the Easy Check breath glucose detection system and the iGlucose™ wireless communication device.

17 Feb 2010

Study demonstrates usefulness of salivary diagnostics in finding pancreatic cancer

The good news is that there may soon be a new weapon in the battle against the so-called "worst" cancer - cancer of the pancreas. A multidisciplinary group of investigators from the UCLA School of Dentistry, the David Geffen School of Medicine at UCLA, the UCLA School of Public Health and UCLA's Jonsson Comprehensive Cancer Center has demonstrated the usefulness of salivary diagnostics in the effort to find and fight the disease.

17 Feb 2010

Exagen Diagnostics, EndoChoice announce agreement for promoting diagnostic services to U.S. gastroenterologists

Exagen Diagnostics, Inc., a molecular diagnostics laboratory that discovers, develops and markets proprietary genomic tests, today announced an exclusive sales and marketing agreement with EndoChoice, Inc. to promote its diagnostic services to gastroenterologists throughout the United States.

17 Feb 2010

ViewRay earns NorTech Innovation Award for advancements in cancer radiation therapy technology

ViewRay, Inc., a privately held medical device company, has earned a NorTech Innovation Award for its advancements in radiation therapy technology for the treatment of cancer. ViewRay was honored for its unique combination of medical imaging and radiotherapy, which is designed to improve the effectiveness of cancer treatments. Radiation therapy is used to treat nearly two-thirds of today's cancer patients.

17 Feb 2010

Sequenom CMM launches SensiGene Fetal Sex Determination test

Sequenom, Inc. today announced the launch of the SensiGene™ Fetal(XY) (Fetal Sex Determination) test by Sequenom's CAP accredited and CLIA-certified laboratory, Sequenom Center for Molecular Medicine (Sequenom CMM). This is the company's second laboratory developed test powered by its SEQureDx™ technology.

17 Feb 2010

Diagnostics News and Research

FDA grants EUA for Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay in CLIA high complexity laboratories

Cantimer, Advanced Instruments announce license and product development agreement

Prevention of preterm birth and stillbirth: Global collaborative efforts needed

Lilly, Merck, Pfizer collaborate to accelerate research on commonly-diagnosed cancer

Global report identifies causes leading to preterm births and stillbirths

Hologic enters into settlement agreement with Ethicon Endo-Surgery

Genoptix signs multi-year licensing agreement with HistoRx for AQUA technology

Micro Imaging Technology becomes Micro Identification Technologies

Roseville ROC commences cancer treatment with Elekta VMAT

New report shows dramatic rise in medical technology, pharmaceuticals and healthcare costs

AutoGenomics awarded ISO 13485 certification for quality management system

Single microRNA exhibits potential to forecast outcomes of MPM

Norwegian government task force suggests formation of single company to commercialise biomaterial assets

HPV DNA testing vital in identification of cervical cancer

Roche Molecular Systems, Merck Sharp & Dohme announce cancer therapeutics collaboration

PositiveID acquires intellectual property rights and assets of Easy Check Medical Diagnostics

Study demonstrates usefulness of salivary diagnostics in finding pancreatic cancer

Exagen Diagnostics, EndoChoice announce agreement for promoting diagnostic services to U.S. gastroenterologists

ViewRay earns NorTech Innovation Award for advancements in cancer radiation therapy technology

Sequenom CMM launches SensiGene Fetal Sex Determination test

Industry Focus eBook - Biotechnology (4th edition) eBook

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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