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Seegene Receives FDA Clearance for its Herpes Simplex Virus Molecular Test
Seegene Inc., a leading developer of multiplex PCR technologies, has been granted FDA 510(k) market clearance for its TOCE-based herpes simplex virus (HSV) types 1 and 2 assay. This is the first product that Seegene has taken through the FDA, and it opens the way for Seegene's other planned FDA submissions of multiplex real-time PCR reagents."This is an important milestone in support of our planned entry into the United States, the largest molecular diagnostic market in the world," ...
Posted on: March 02, 2015
Thermo Fisher Scientific Signs Distribution Agreement with Cynvenio for LiquidBiopsy Platform
Thermo Fisher Scientific has signed an agreement with Cynvenio Biosystems Inc., a molecular testing company focused on the genomic analysis of tumor biomarkers in the bloodstream, for rights to distribute its LiquidBiopsy platform.The addition of Cynvenio's rare cell enrichment technology complements Thermo Fisher's Ion Torrent Personal Genome Machine (PGM) workflow and positions the company as the only one in the industry to offer a comprehensive sample-to-genomic data solution for research using a ...
Posted on: March 01, 2015
AMP Position Statement: Direct to Consumer Genetic Testing
In 2007, the Association for Molecular Pathology (AMP) published a position statement on direct access genetic testing (direct to consumer genetic testing) which concluded that genetic testing should be available only through appropriately qualified health professionals that order tests from laboratories that are certified by CLIA for high complexity testing. In 2014, HHS finalized a new rule that gives patients direct access to test results, including genetic test results, directly from the laboratory ...
Posted on: February 27, 2015
Study Demonstrates High Sensitivity of Trovagene's Urine-Based HPV Assay for the Detection of High Risk HPV and Pre-Cancerous Cervical Lesions
Trovagene Inc., a developer of cell-free molecular diagnostics, announced the clinical results from the PREDICTORS 4 trial, which demonstrate high sensitivity for the company's non-invasive, urine-based HPV assay when determining high-risk human papillomavirus (HPV) types and cervical lesions or cervical intraepithelial neoplasia (CIN) Grade 2/3. Jack Cuzick, PhD, director, Wolfson Institute of Preventive Medicine and Head, Centre for Cancer Prevention at Queen Mary University of London, presented ...
Posted on: February 26, 2015
Thermo Fisher Scientific Releases New CE-IVD Tumor Panel for Next Generation Sequencing
The newly released CE-IVD Oncomine Solid Tumor DNA kit from Thermo Fisher Scientific enables highly accurate and reliable multiplexed sequencing of formalin-fixed, paraffin embedded (FFPE) tumor samples with the quality and performance needed for the clinical laboratory.Compared to other molecular diagnostic testing methods, such as qPCR or Sanger sequencing, next-generation sequencing (NGS) can assess a broader range of genes in a single test. Based on the Ion Torrent AmpliSeq Technology, the kit allows ...
Posted on: February 25, 2015
New Genomic Test Can Direct Appropriate Use of Radiation Therapy Following Prostate Surgery
GenomeDx Biosciences announced the publication of a positive validation study for the Decipher Prostate Cancer Classifier, a genomic test for prostate cancer, this month. The study, published in the Journal of Clinical Oncology, showed that patients with low genomic risk (as determined by Decipher) may be optimally managed with observation after radical prostatectomy (prostate surgery), while those with high genomic risk (as determined by Decipher) may be better managed earlier with adjuvant radiotherapy. ...
Posted on: February 24, 2015
Visiun Releases Test Utilization Management Reporting for Laboratories Nationwide
Visiun Inc., a leader in performance analytics for the laboratory, announced the release of a utilization management reporting system for laboratories nationwide. This new solution will help laboratories identify opportunities to eliminate unnecessary testing. In an environment of decreasing reimbursements, test utilization represents one of the greatest opportunities for laboratories to improve financial performance."The move away from fee-for-service toward other models of reimbursement has managers ...
Posted on: February 23, 2015
ASCP's '40 Under 40' Program Recognizes Future Lab Leaders
The American Society for Clinical Pathology (ASCP) is accepting applications for its "40 Under 40" program which recognizes 40 pathologists, pathology residents, and laboratory professionals under age 40 who have made contributions to the profession and stand out as the future of laboratory leadership. The deadline to apply is March 16. "ASCP's 40 Under 40 program is an opportunity to recognize the next generation of medical laboratory leaders," says ASCP President William G. Finn, ...
Posted on: February 22, 2015
QIAGEN Introduces QuantiFERON Monitor for Tracking Immune Function in Solid Organ Transplant Patients
QIAGEN N.V. has announced the commercial launch of QuantiFERON Monitor (QFM), a novel diagnostic for monitoring immune function. QIAGEN is launching QuantiFERON Monitor in Europe as a CE-marked in-vitro diagnostic. Primary applications include monitoring of immune function in solid organ transplant recipients. In North America and other markets, QFM is available for research use as an accurate marker of immune function in studies of immunosuppressive conditions, immune modulating therapies and recovery ...
Posted on: February 20, 2015
T2 Biosystems and Canon U.S. Life Sciences Announce Joint Collaboration to Develop Novel Test Panel to Rapidly Detect Lyme Disease
T2 Biosystems, a company developing innovative diagnostic products to improve patient health has announced that the company has entered into a multi-year, strategic agreement with Canon U.S. Life Sciences to jointly develop a novel diagnostic test panel to rapidly detect Lyme disease, a tick-borne bacterial infection that, if left untreated, can cause chronic joint inflammation, neurological disorders and cognitive defects.Under the terms of the agreement, T2 Biosystems will receive an upfront payment of ...
Posted on: February 19, 2015
European Hantavirus Diagnostics Market Tops US Market as a Result of Higher Disease Prevalence
The European Hantavirus diagnostics market is growing at a compound annual growth rate (CAGR) of 5.8%, outperforming the U.S. market, which registered 3.7 percent. The European market is more robust primarily due to Hantavirus' high prevalence rates in Russia, Scandinavia, Finland and Belgium. However, the U.S. market has higher mortality rates (50%) associated with the disease, even though it has no more than 40 reported cases every year.New analysis from Frost & Sullivan finds the Hantavirus testing ...
Posted on: February 18, 2015
Claritas Genomics Caps Landmark Year with New Investment
Claritas Genomics has secured $15 million in capital for its Series B round to expand its commercial operations, launch new next generation sequencing-based tests for diagnosis of pediatric genetic disorders and continue to build its network of clinical pediatric disease experts.The announcement is the latest in a series of milestones for Claritas, which spun out of Boston Children's Hospital in February 2013. Early last year the company obtained a contract with the Million Veteran Program to ...
Posted on: February 17, 2015
Roche Receives FDA Clearance for Next Generation Cobas MRSA/SA Test
Roche has received FDA 510(k) clearance for the cobas MRSA/SA Test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) directly from nasal specimens. The cobas MRSA/SA Test detects both organisms from a single specimen, providing accurate and reliable results for effective prevention and control of MRSA/SA infections."Numerous successful surveillance programs have led to a significant decrease in the rate of MRSA ...
Posted on: February 16, 2015
Caris Molecular Intelligence Identifies Therapeutic Options, Novel Immunotherapeutics, for Patients with Rare Carcinoma
Caris Life Sciences presented data from a study in which Caris Molecular Intelligence(TM), the company's panomic, comprehensive tumor profiling service, identified potentially actionable alterations in patients with recurring or metastasized anal squamous cell carcinoma (ASCC), a rare human papilloma virus (HPV)-associated malignancy accounting for 2.4% of digestive system cancers. The data, presented at the 2015 Gastrointestinal Cancers Symposium in San Francisco, Calif., point toward potential ...
Posted on: February 15, 2015
Philips and Indica Labs Team to Accelerate Cancer Research through Advanced Image Analysis
Royal Philips has announced that it will further support oncology researchers' efforts to analyze pathology samples by offering advanced image analysis algorithms from Indica Labs, as part of its Digital Pathology Solutions offerings. The collaboration will allow pathology researchers to apply intelligent algorithms to digitized pathology slides, which may enhance their ability to detect, process and extract information from tissue samples than currently possible using a conventional microscope.Image ...
Posted on: February 15, 2015