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FDA Grants Diazyme Clearance to Market Its Vitamin D Assay for Clinical Chemistry Analyzers

Diazyme Laboratories announced that the FDA has granted 510(K) clearance to market its Vitamin D assay for clinical chemistry analyzers. In line with the rapid increasing clinical demands for testing of this important biomarker, Diazyme's new vitamin D assay, utilizing its FemtoQuant technology (a sensitive homogenous enzyme-immunoassay platform), provides the first fully automated Vitamin D test for use on general clinical chemistry analyzers. Diazyme's Vitamin D assay measures total 25-hydroxy ...

Posted on: April 24, 2014
Rosetta Genomics to Receive U.S. Patent for Cancer Origin Assay

Rosetta Genomics, a developer and provider of microRNA-based molecular diagnostics and therapeutics, has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent covering the method of use of a core element of Rosetta Genomics' microRNA technology in the identification of the tumor of origin in cancer of unknown or uncertain primary and metastatic cancer. The issued claims for U.S. Patent Application No. 13/167,489 is entitled "Gene Expression ...

Posted on: April 23, 2014
Saladax Blood Test for Chemotherapy Dosing Solution

Saladax Biomedical Laboratories is offering a simple blood test for the personalization and optimization of 5-fluorouracil (5-FU) dosing to help oncologists improve treatment outcomes and minimize the drug's toxic side effects. The test is called My5-FU™. 5-FU is a chemotherapy drug commonly used in the treatment of many different cancer types, including colorectal, head and neck and breast cancers. Presently, chemotherapy dosing is based on the body surface area (BSA) ...

Posted on: April 22, 2014
Definiens Sponsors the World Wide Clinical Validation of the Immunoscore

Definiens, the global leader in image analysis for digital pathology and diagnostics, announced today that it has signed an agreement with INSERM Transfert to sponsor the worldwide consortium for the validation of the Immunoscore, a new approach to cancer therapy that has been called "transformational."A team led by Professor Jérôme Galon, a prominent Immunologist, has demonstrated that the number, type, and location of tumor-infiltrating lymphocytes in primary tumors have prognostic value. Clinical data ...

Posted on: April 21, 2014
HTG Molecular Diagnostics and OvaGene Oncology Partner on Gynecologic Cancer Tests

HTG Molecular Diagnostics and OvaGene Oncology have entered a manufacturing supply agreement where OvaGene will design and develop their proprietary gene expression assays on HTG's fully automated, extraction-free Edge Platform. The HTG Edge System is the only extraction-free, automated gene expression platform that delivers affordable, multiplexed results on lysed samples in less than a day. The Edge System's multiplexing capability, utilizing only one five-micron thick FFPE section, provides a ...

Posted on: April 20, 2014
Quest Launches Website Enabling Patients to Access Lab Data under New Federal Rule that takes effect today

For the first time, Americans nationwide can directly access their personal laboratory data through Quest Diagnostics, the world's leading provider of diagnostic information services. Quest Diagnostics provides diagnostic information services to about 30% of American adults each year.Under a federal rule that went into effect last week, patients in all 50 states and the District of Columbia can now view test results from diagnostic information service providers without first being authorized by ...

Posted on: April 18, 2014
hc1.com and Beckman Coulter Diagnostics Enter Strategic Partnership to Bring Cloud Technology to Labs

hc1.com, the Healthcare Relationship Cloud company, and Beckman Coulter Diagnostics, a global leader in developing clinical diagnostic products that help advance and optimize the laboratory, announced a strategic partnership to deliver innovative technology to laboratories that turn large amounts of clinical data into actionable insights that transform how labs manage their business and their contributions to improving healthcare.The partnership between hc1.com and Beckman Coulter Diagnostics creates ...

Posted on: April 17, 2014
Focus Diagnostics Receives FDA Clearance for Moderate Complexity Simplexa HSV 1 & 2 Direct Molecular Test for Aiding the Diagnosis of Encephalitis

Quest Diagnostics has announced that its Focus Diagnostics products business has received expedited FDA 510(k) clearance and CLIA moderate complexity categorization for its new Simplexa HSV 1 & 2 Direct molecular test on the 3M Integrated Cycler. The test, which is now available for purchase in the United States, is the first molecular test to be cleared by the FDA for the qualitative detection and differentiation of herpes simplex virus 1 (HSV-1) and herpes simplex virus 2 (HSV-2) in cerebrospinal ...

Posted on: April 16, 2014
Ventana Signs CDx Agreement with Genmab Antibody Drug Conjugate Program

Ventana Medical Systems, a member of the Roche Group, has entered into an agreement with Genmab A/S, Copenhagen, Denmark, for the development of companion diagnostic tools for Genmab's HuMax-TF-ADC antibody drug conjugate (ADC) program. As part of the agreement, Ventana will provide its expertise and services toward the development of an immunohistochemistry (IHC) companion diagnostic test for the detection of tissue factor (TF) in patient tumor samples. The TF assay will be developed for possible ...

Posted on: April 15, 2014
COLA Announces 2014 Leadership Summit in San Francisco

COLA, the largest private accreditor of medical laboratories including more than 8,000 nationwide, has announced its 2014 Leadership Summit, which will bring together leaders across healthcare disciplines to collaborate on the future of laboratory medicine nationwide. Held at the historic Fairmont Hotel in San Francisco, the summit will take place April 28-29, and is expected to generate papers and other materials that reflect the group's insights on the topic of creating a culture of quality in ...

Posted on: April 14, 2014
ACLA Supports SGR Extension Legislation's CLFS Reform Provision

The American Clinical Laboratory Association (ACLA) -- a not-for-profit association representing the nation's leading national and regional clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies - issued the following statement regarding the Clinical Laboratory Fee Schedule (CLFS) provisions in the SGR extension legislation that was recently posted in the U.S. House of Representatives.ACLA offers its support to the SGR ...

Posted on: April 13, 2014
CAP Awarded More Than $1.25 Million in CDC Grants

College of American Pathologists (CAP), the world's largest organization of board-certified pathologists, has been awarded two grants from the Centers for Disease Control and Prevention (CDC). The funding, totaling more than $1.25 million, will be used to improve the adoption of evidence-based laboratory testing guidelines and to standardize reporting of biomarker test results to cancer registries. The grant dollars will be used over a five-year period."Patients and physicians rely on accurate and ...

Posted on: April 11, 2014
Triple Negative Breast Cancer's Progression and Relapse Pinned to a Gene

Scientists from Houston Methodist and Weill Cornell Medical College have found that a gene previously unassociated with breast cancer plays a pivotal role in the growth and progression of the triple negative form of the disease, which can be particularly deadly, with few treatment options. Their research, published in the April 3 Nature, suggests that targeting the gene may be a new approach to treat the disease."We are really beginning to understand what initiates the cancer and why cancer cells ...

Posted on: April 11, 2014
Quidel Receives FDA Clearance for Its AmpliVue(R) Hand-Held Molecular Diagnostic Test for Herpes Simplex Virus Types 1 and 2

Quidel Corporation, a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, has received 510(k) clearance from the FDA for the sale of its AmpliVue HSV 1+2 Assay for the differentiation and detection of herpes simplex viruses 1 and 2.The AmpliVue HSV 1+2 Assay is easy-to-use, handheld and disposable. The assay requires no upfront extraction of DNA and generates an accurate result in approximately one hour. Like other previously FDA-cleared ...

Posted on: April 10, 2014
Venaxis Files for FDA Clearance of APPY1 Test

Venaxis, an in vitro diagnostic company focused on obtaining FDA clearance for and commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based index assay for identifying patients that are at low risk for appendicitis, today announced that it has filed a 510(k) premarket submission for the APPY1 Test.  Venaxis has requested concurrent de novo determination and 510(k) clearance from the FDA.In its pivotal U.S. clinical study, the APPY1 Test performed with negative predictive value ...

Posted on: April 09, 2014
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