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Protalix receives FDA CRL for taliglucerase alfa NDA for Gaucher disease

Protalix BioTherapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease. Taliglucerase alfa is a plant-cell expressed form of glucocerebrosidase (GCD).

25 Feb 2011

Quanterix expands its Single Molecule Array technology to measure proteins precisely

Quanterix Corporation, a single molecule diagnostics company providing technology with unprecedented sensitivity for the life science and in vitro diagnostics markets, today announced the online publication of a study that builds upon the company's Single Molecule Array technology by combining digital and analog detection in one straightforward measurement.

24 Feb 2011

FDA allows marketing of Ridascreen Norovirus 3rd Generation EIA assay in the US

The U.S. Food and Drug Administration allowed marketing of the first test for the preliminary identification of norovirus.

24 Feb 2011

FDA clears Agendia's breast cancer recurrence assay

Agendia, a world leader in molecular cancer diagnostics, today announced that the company has received its fifth U.S. Food and Drug Administration clearance for MammaPrint, its widely used breast cancer recurrence assay.

23 Feb 2011

Pretreatment with FDA-approved drug allows successful pregnancies in radiation-exposed rhesus monkeys

A strategy developed by Massachusetts General Hospital (MGH) researchers to shield the ovaries of female mammals from the damaging effects of radiation and chemotherapy has passed an important milestone. A collaborative study with investigators from Oregon Health and Sciences University (OHSU), published online in the journal Fertility and Sterility, reports that brief preexposure of the ovaries to an FDA-approved agent called FTY720 preserved the fertility of female rhesus monkeys exposed to potentially lethal doses of radiation.

23 Feb 2011

Biomoda completes sample collection in pilot study of CyPath diagnostic assay for lung cancer

Cancer diagnostics company Biomoda, Inc. today announced that it has completed patient enrollment and sample collection for the pilot study to determine the clinical sensitivity and specificity of its CyPath® diagnostic assay for the early detection of lung cancer.

23 Feb 2011

NanoString launches fixed-panel assay product for human molecular karyotyping

NanoString Technologies, Inc., a privately held life sciences company marketing a complete solution for detecting and counting large sets of target molecules in biological samples, today announced the first fixed-panel assay product to be developed on its Copy Number Variation detection platform - the nCounter Human Karyotype Panel.

From NanoString Technologies 22 Feb 2011

MedTrust, Avantra collaborate to develop molecular diagnostic assay for cancer care

MedTrust Online and Avantra Biosciences announced today a novel collaboration to involve clinicians in the earliest stages of molecular diagnostic assay development for Avantra Biosciences' revolutionary QPDx multiplex immunoassay system.

22 Feb 2011

New diagnostic tool to detect patients with active TB disease

Tuberculosis remains one of the most pressing public health priorities for the 21st century, with over one third of the world population infected. Active TB disease is a major issue both for the patients who require specific treatment and at a population level, since these patients are contagious.

21 Feb 2011

Life Technologies announces winners of European Ion Torrent PGM Sequencer Grants Program

Life Technologies Corporation, today announced Dr. Angel Carracedo and Dr. Mark Pallen as the winners of the European Ion Torrent Personal Genome Machine (PGM™) Sequencer Grants Program.

19 Feb 2011

Predictive to present results on development of real-time multiplexed PCR FGFR3 assay at ASCO 2011

Predictive Biosciences today announced that the Company will be presenting results on the development of a real-time multiplexed PCR assay for detection of FGFR3 mutations in urine and tissue at the American Society of Clinical Oncology (ASCO) 2011 Genitourinary Cancers Symposium being held February 17 - 19 in Orlando, Florida. Results will also focus on the application of the assay which is currently being used in Predictive's first commercial molecular grading product, the CertNDxTM Molecular Grading Assay.

19 Feb 2011

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

Novavax, a clinical-stage biopharmaceutical company, today presented the final safety and immunogenicity results from its 2009 H1N1 virus-like particle pandemic influenza vaccine clinical trial in Mexico at the invitation-only 7th World Health Organization Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials.

19 Feb 2011

New study: Asthma may have relationship with airway microbiota composition

Asthma may have a surprising relationship with the composition of the species of bacteria that inhabit bronchial airways, a finding that could suggest new treatment or even potential cures for the common inflammatory disease, according to a new UCSF-led study.

18 Feb 2011

U.S. Patent Office issues Notice of Allowance to Biomoda's CyPath assay for cancer detection

Cancer diagnostics company Biomoda, Inc. received Notice of Allowance for a U.S. Patent application on a quantitative method for scoring cells labeled with the CyPath assay to determine whether cells are dysplastic or carcinomic by measuring the photon emission rate.

17 Feb 2011

Researchers develop new DNA test for accurate detection of Turner syndrome in children

As a child grows, a short stature is not usually cause for concern, but it is often the only sign of a condition called Turner syndrome. Prevalent in girls, Turner syndrome is a genetic defect that short-circuits normal growth and leads to cardiac and renal problems. It is not commonly detected until age 10 or older when a youngster's unusually short height raises suspicions.

16 Feb 2011

IMGM Labs purchases Fluidigm Access Array system to use in re-sequencing applications

IMGM Laboratories GmbH has purchased a Fluidigm Access Array System to use in its development and validation of targeted re-sequencing applications services.

16 Feb 2011

Study explores role of proline containing peptides in inhibiting anti-apoptotic function of XIAP

Basic and translational research on cancer, and development of new cancer therapeutics, has focused on different aspects of cancer cellular function. One area of focus is the life and death of a cancer cell. Apoptosis, also known as programmed cell death, is a fundamental process of cells including cancer cells. The signal transduction pathways of apoptosis involve many different proteins and their interactions with each other.

16 Feb 2011

NGDI-UBC, CDRD partner for drug development platform to treat neglected global diseases

The Centre for Drug Research and Development and the Neglected Global Diseases Initiative at the University of British Columbia today announced that they will collaborate on developing interventions for neglected global diseases and ensuring their delivery to those in need.

16 Feb 2011

Study sheds new light on riboswitch that turns genes on or off in response to cell's energy needs

Scientists from The Scripps Research Institute have shed new light on a molecular switch that turns genes on or off in response to a cell's energy needs.

13 Feb 2011

Patients with sensorineural hearing loss can benefit from mucosa-derived stem cell transplant

Stem Cell scientists in Australia have found that patients suffering from hearing problems which began during infancy and childhood could benefit from a transplant of stem cells from their nose. The research, published today in STEM CELLS, reveals that mucosa-derived stem cells can help preserve hearing function during the early-onset of sensorineural hearing loss.

10 Feb 2011

Assay News and Research

Protalix receives FDA CRL for taliglucerase alfa NDA for Gaucher disease

Quanterix expands its Single Molecule Array technology to measure proteins precisely

FDA allows marketing of Ridascreen Norovirus 3rd Generation EIA assay in the US

FDA clears Agendia's breast cancer recurrence assay

Pretreatment with FDA-approved drug allows successful pregnancies in radiation-exposed rhesus monkeys

Biomoda completes sample collection in pilot study of CyPath diagnostic assay for lung cancer

NanoString launches fixed-panel assay product for human molecular karyotyping

MedTrust, Avantra collaborate to develop molecular diagnostic assay for cancer care

New diagnostic tool to detect patients with active TB disease

Life Technologies announces winners of European Ion Torrent PGM Sequencer Grants Program

Predictive to present results on development of real-time multiplexed PCR FGFR3 assay at ASCO 2011

Novavax announces final safety, immunogenicity results from H1N1 VLP vaccine at WHO meeting

New study: Asthma may have relationship with airway microbiota composition

U.S. Patent Office issues Notice of Allowance to Biomoda's CyPath assay for cancer detection

Researchers develop new DNA test for accurate detection of Turner syndrome in children

IMGM Labs purchases Fluidigm Access Array system to use in re-sequencing applications

Study explores role of proline containing peptides in inhibiting anti-apoptotic function of XIAP

NGDI-UBC, CDRD partner for drug development platform to treat neglected global diseases

Study sheds new light on riboswitch that turns genes on or off in response to cell's energy needs

Patients with sensorineural hearing loss can benefit from mucosa-derived stem cell transplant

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

Examining how pain could play a direct protective role in the gut

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