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Roche Receives FDA Approval for cobas KRAS Mutation Test

The FDA has recently approved Roche's cobas KRAS Mutation Test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer (mCRC) patients and aid clinicians in determining a therapeutic path for them.According to the CDC, colorectal cancer is the second leading cause of cancer-related deaths in the United States and the third most common cancer in men and women.  The cobas KRAS Mutation Test is intended to be used as an ...

Posted on: May 27, 2015
CAP and ADASP Offer New Guideline to Improve Laboratory Testing

The College of American Pathologists (CAP) and the Association of Directors of Anatomic and Surgical Pathology (ADASP) yesterday announced the joint release of a new evidence-based guideline to provide recommendations for secondary and timely reviews of surgical pathology and cytology cases to improve patient care. The guideline, "Interpretive Diagnostic Error Reduction in Surgical Pathology and Cytology http://www.archivesofpathology.org/doiabs/10.5858/arpa.2014-0511-SA,"," has been posted as an ...

Posted on: May 26, 2015
Study in the Clinical Biochemistry Journal Identifies the Precise Magnitude of Change in Cardiac Troponin Required for Early Diagnosis of a Heart Attack

Beckman Coulter Diagnostics announces the publication of research results in the Clinical Biochemistry journal that identifies the precise magnitude of change in cardiac troponin required for early diagnosis of a heart attack (myocardial infarction, or MI), utilizing its Access AccuTnI+3 troponin I blood test. Beckman Coulter's troponin-I assay has been clinically proven through a large, multi-center study and is the only troponin assay currently cleared by the FDA that is directly aligned with ...

Posted on: May 26, 2015
Nova StatStrip Glucose Hospital Meter System Now Offers Wireless Meter Connectivity

Nova Biomedical's StatStrip Glucose Hospital Meter System now offers bidirectional wireless connectivity to the hospital's HIS or LIS with complete security to protect patient data.StatStrip Glucose's wireless connectivity can transmit patient results directly from the patient bedside, alleviating the need to bring the meter to a fixed location for meter docking and data transmission. Wireless connectivity saves time for the caregiver and allows for faster charting of results and clinical decision making ...

Posted on: May 25, 2015
New Test Could Identify Resistant Tuberculosis Faster

The time needed to genetically sequence the bacteria causing tuberculosis (Mtb) from patient samples has been reduced from weeks to days using a new technique developed by a UCL-led team. This could help health service providers to better treat disease, control transmission of this infection, and monitor outbreaks.Tuberculosis (TB) disease rates in some parts of London are as high as in Sub-Saharan Africa, and drug-resistant strains are becoming increasingly common. These require specific treatments, and ...

Posted on: May 24, 2015
Quest Diagnostics to Enhance Quality of Noninvasive Prenatal Screening with QNatal Advanced

Quest Diagnostics, the leading provider of diagnostic information services and a leader in women's health and genomic testing, has launched QNatal Advanced, a noninvasive prenatal screening service for detecting chromosomal abnormalities in high-risk pregnancies.QNatal Advanced analyzes cell-free fetal DNA in circulating maternal blood to screen for common and rare chromosomal abnormalities, including those associated with trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), trisomy 13 (Patau ...

Posted on: May 22, 2015
FDA Clears COPAN's FecalSwab to Simplify Enteric Culture and Molecular Diagnostics

COPAN,  focused on bringing breakthrough products to microbiology preanalytics around the world, announced that it has obtained FDA clearance for its new FecalSwab. FecalSwab is comprised of a regular size COPAN flocked swab (FLOQSwab) and a screw cap tube containing 2mL of Cary-Blair medium. Because of its high pH, Cary-Blair is the medium of choice for transport and preservation of enteric bacteria. FecalSwab is intended for the collection of rectal swabs and fecal specimens and to preserve ...

Posted on: May 21, 2015
cobas Liat PCR System and the cobas Strep A test now CLIA waived

Roche Diagnostics announced this week that the FDA has granted CLIA waiver for the cobas Liat PCR System and the cobas Strep A test. The cobas Liat System is the first and only FDA-cleared device to offer Nobel Prize-winning polymerase chain reaction (PCR) technology at the point of care, including doctor's offices and pharmacies. The cobas Liat System allows laboratory staff to extend and enhance their services to physicians and their patients by providing on-demand STAT diagnostic ...

Posted on: May 20, 2015
Beckman Coulter Features Prostate Health Index (phi) at 2015 AUA Annual Meeting

The Beckman Coulter exhibition booth this week at the 2015 American Urological Association (AUA) Annual Meeting in New Orleans, LA, showcased the company's Prostate  Health Index (phi) - the solution for better prostate cancer detection. The Prostate Health Index is: A simple blood test that is three times more specific for the detection of prostate cancer than PSA alone The only multi-analyte PCa blood test with FDA approval The only multi-analyte blood test recommended in the ...

Posted on: May 19, 2015
New Malaria Test Could Lead to Global Eradication of the Disease

One of the biggest difficulties faced by worldwide programs aimed at eliminating malaria is that the tests they use are not sensitive enough to detect all people who have the disease and need treatment. A study appearing online in Clinical Chemistry, the journal of AACC, shows that a new test known as capture and ligation probe-PCR (CLIP-PCR) could diagnose the malaria cases that would typically escape detection and lead to new infections.Malaria control programs have achieved remarkable success in the ...

Posted on: May 18, 2015
iSpecimen Technology Consolidates the Procurement Process for Human Biospecimens

iSpecimen, a source of customized human biospecimen collections, has released its latest technology that connects biomedical researchers to high quality, annotated human biospecimens that would otherwise be discarded by hospitals and labs after clinical testing is complete. Through this model, researchers gain access to the specimens they need from the patients they want and healthcare providers gain a new opportunity to contribute to biomedical research while improving their bottom line. Each year, ...

Posted on: May 17, 2015
XIFIN Acquires Imaging Informatics Company VisualShare

XIFIN Inc., the healthcare cloud computing company specializing in the business of healthcare diagnostics from patient to payment, has announced the acquisition of VisualShare, a Salt Lake City-based medical informatics company specializing in diagnostic image management. VisualShare will expand XIFIN's capabilities to deliver enhanced continuity of care documentation, and facilitate robust multidisciplinary team collaboration through its Health Economics Optimization platform. The ...

Posted on: May 15, 2015
IDT Opens Molecular Biology R&D Facility in Redwood City

The world's leader in custom nucleic acid synthesis, Integrated DNA Technologies (IDT) is capitalizing on its expertise to deliver a broader range of validated molecular biology products. Research and development for these products will now be performed in a newly built facility in Redwood City, Calif. The 8,000 square foot building houses state-of-the-art labs that will allow IDT scientists to maximize the company's world-class custom oligonucleotide manufacturing capability. This new Center of ...

Posted on: May 13, 2015
Abbott's First-of-its-Kind Blood Test to Aid in Detecting Early Pregnancy

Women account for nearly 60 percent of visits to emergency departments (ED) in the United States. In emergency situations, it is critical for doctors to know the pregnancy status of women who are of childbearing age as soon as possible, since this influences decision-making when it comes to medications, imaging, surgery and other clinical care.Traditionally, clinicians rely on urine-based pregnancy testing, but collecting a sample from a woman in an emergency setting can be difficult, especially if ...

Posted on: May 12, 2015
FDA Clears the Focus Diagnostics Simplexa Group A Strep Direct Test

Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics has announced the FDA 510(k) clearance and CLIA moderate-complexity categorization for its Simplexa Group A Strep Direct Kit.  Simplexa Group A Strep Direct is a real-time polymerase chain reaction assay for the detection of Group A Streptococcus bacteria directly from throat swabs. The most prevalent form of Group A Streptococcus (GAS) is strep throat (pharyngitis), a condition most ...

Posted on: May 11, 2015
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