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Agilent, Integrated Diagnostics partner to improve protein-based LC/MS assays

Agilent Technologies Inc. and Integrated Diagnostics today announced a strategic partnership to develop assays that detect major human diseases at very early stages to improve treatment outcomes.

11 Jan 2012

NanoInk launches new automated protein NanoArray assay platform

The Nano BioDiscovery™ Division of NanoInk®, Inc. announced today the release of a new automated platform for the analysis of its protein NanoArray assays. NanoInk’s NanoArray Assay System™ enables detection, identification, and quantitation of clinically relevant, low abundance proteins from a wide variety of sample types for applications such as biomarker analysis, translational medicine, and toxicology.

10 Jan 2012

Aria's non-invasive test more effective in detecting Trisomy 18 & 21

Aria Diagnostics, a molecular diagnostics company, today announced publication of data supporting a directed, non-invasive approach to cell-free DNA (cfDNA) analysis in maternal blood for evaluation of two common fetal trisomies linked to genetic disorders.

10 Jan 2012

CMS increases NLA for T-SPOT.TB test's CPT code 86481

Oxford Immunotec, Inc. announces that, following a reconsideration request made by the company, the Centers for Medicare and Medicaid Services has increased the national limitation amount (NLA) for the Current Procedural Terminology (CPT) code 86481 which is used for the T-SPOT.TB test.

10 Jan 2012

Urinary biomarkers can diagnose AKI in high-risk patients

Acute kidney injury (AKI) has severe consequences, with a 25 to 80 percent risk of in-hospital death. Researchers have found a way to diagnose AKI using a urine test, enabling emergency departments to identify these high-risk patients when they first arrive at the hospital.

10 Jan 2012

Researchers uncover exact function of LARGE enzyme linked with MD

Researchers at the University of Iowa have worked out the exact function of an enzyme that is critical for normal muscle structure and is involved in several muscular dystrophies. The findings, which were published Jan. 6 in the journal Science,, could be used to develop rapid, large-scale testing of potential muscular dystrophy therapies.

10 Jan 2012

Neomatrix, UND partner to develop technology for early detection of breast cancer

The University of North Dakota and Neomatrix, LLC, have signed an exclusive agreement to develop technology for the early detection of breast cancer using the company's HALO Breast Pap Test device.

9 Jan 2012

MPIIB, QIAGEN partner to develop latent TB diagnostic test

QIAGEN N.V. and the Max Planck Institute for Infection Biology (MPIIB), Department of Immunology have announced a new collaboration to develop a molecular diagnostic test to assess the risk of an individual with latent tuberculosis (TB) developing active TB disease during their lifetime.

From QIAGEN Manchester Limited 9 Jan 2012

Scientists develop simple, reliable test to identify biomarkers for MPS

A team of scientists, led by researchers at the University of California, San Diego School of Medicine and Zacharon Pharmaceuticals, have developed a simple, reliable test for identifying biomarkers for mucopolysaccharidoses (MPS), a group of inherited metabolic disorders that are currently diagnosed in patients only after symptoms have become serious and the damage possibly irreversible.

8 Jan 2012

Roka raises $47.5M in Series D round

Roka Bioscience announced today that it has secured $47.5 million in Series D financing. New investor Aisling Capital participated in the financing along with existing investors OrbiMed Advisors, New Enterprise Associates, Inc., and TPG Biotech. In conjunction with the financing, Josh Bilenker, M.D., Partner at Aisling Capital, will join Roka's Board of Directors.

6 Jan 2012

Boulder Diagnostics, RUNMC enter agreement to market Lyme disease diagnostic test

Boulder Diagnostics Inc. and the Department of Internal Medicine, Radboud University Nijmegen Medical Centre announced today the entry into a license and collaboration agreement to market the innovative Lyme disease diagnostic test developed at RUNMC.

5 Jan 2012

New standards to ensure quality of probiotic food ingredients proposed

With strong consumer interest in probiotics-and new manufacturer innovations for incorporating these ingredients into a broader array of food products-new standards to help ensure the quality of probiotic food ingredients are being proposed for public review and comment.

4 Jan 2012

TrovaGene acquires license to mutations of SF3B1 splicing factor in CLL

TrovaGene, Inc., a developer of trans-renal molecular diagnostics, today announced that it has obtained an exclusive worldwide license to mutations of the SF3B1 splicing factor, which have been shown to be associated with disease progression and chemotherapy response in patients suffering from chronic lymphocytic leukemia.

3 Jan 2012

Major European medical center includes Critical Diagnostics' Presage ST2 Assay for cardiac care

Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, announced today that a major European medical center, Hospital Germans Trias i Pujol in Barcelona Spain, is now using the company's Presage ST2 Assay for routine care and management of their heart failure patients.

2 Jan 2012

CHEST Foundation awards $100,000 for development of blood test for lung cancer

Lung cancer takes a heavy toll, contributing to more cancer deaths in the United States each year than breast, prostate and colon cancers combined. Contributing to this poor prognosis is the fact that lung cancer often goes undetected until the disease has reached an advanced and more difficult-to-treat stage.

31 Dec 2011

Troponin I level test may help rule-out diagnosis of heart attack

For patients admitted to an emergency department with chest pain, use of a contemporary or highly sensitive test for levels of troponin I (a protein in muscle tissue) may help rule-out a diagnosis of heart attack, while changes in the measured levels of this biomarker at 3 hours after admission may be useful to confirm a diagnosis of heart attack, according to a study in the December 28 issue of JAMA.

28 Dec 2011

FDA clears Meridian Bioscience's new Clostridium difficile assay

Meridian Bioscience, Inc., Cincinnati, Ohio today announced it has received FDA clearance for a new Clostridium difficile assay, ImmunoCard C. difficile GDH.

27 Dec 2011

Critical Diagnostics receives FDA clearance for Presage ST2 Assay

Critical Diagnostics, a U.S.-based biomarker company focused on cardiovascular diseases, announced today that the U.S. Food and Drug Administration has cleared the company's Presage ST2 Assay for use as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.

16 Dec 2011

FDA approves modernized labeling for ViroPharma's Vancocin Capsules

ViroPharma Incorporated today announced the modernization of labeling for Vancocin (vancomycin hydrochloride, USP) Capsules made effective through the U.S. Food and Drug Administration's (FDA) approval of a supplemental new drug application.

15 Dec 2011

Fast Forward, Lineagen to fund clinical development and validation of blood-based assay for MS

Lineagen, Inc., an innovative molecular diagnostics company focused on complex, genetically linked disorders, and Fast Forward, LLC, a nonprofit subsidiary of the National Multiple Sclerosis Society, today announced an alliance to fund the clinical development and validation of a blood-based assay for multiple sclerosis.

15 Dec 2011