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New Assay Helps Determine Lymphoma Subtypes Quickly and Inexpensively
With the advent of targeted lymphoma therapies on the horizon, it becomes increasingly important to differentiate the two major subtypes of diffuse large B-cell lymphoma (DLBCL), which is the most common non-Hodgkin lymphoma. These are germinal center B-cell-like (GCB) and activated B-cell-like (ABC), which differ in management and outcomes. A report in The Journal of Molecular Diagnostics describes use of the reverse transcriptase-multiplex ligation-dependent probe amplification (RT-MLPA) assay ...
Posted on: April 27, 2015
The Eeva Test is First and Only Non-invasive, Predictive Test to Aid in Embryo Selection
The Eeva Test is now commercially available in the United States following its recent FDA clearance. This breakthrough technology is designed to help fertility clinics select the best embryos during in vitro fertilization (IVF) to aid in their effort to provide the best chance of a successful pregnancy.The Eeva Test is a first-in-class, non-invasive predictive test that enhances the embryo selection process by taking images of the embryos during the incubation period. The Test uses proprietary ...
Posted on: April 26, 2015
Association for Molecular Pathology Compiles Current Research on Liquid Biopsy
The Association for Molecular Pathology (AMP), a global, non-profit organization serving molecular diagnostic professionals, published a special article in The Journal of Molecular Diagnostics titled, "Do Circulating Tumor Cells, Exosomes, and Circulating Tumor Nucleic Acids Have Clinical Utility?" The report provides a thorough overview of research to-date on the minimally invasive "liquid biopsy" approaches to cancer diagnostics."As a group of molecular diagnostic experts, we were intrigued ...
Posted on: April 24, 2015
BioFire Submits De Novo Application to FDA for FilmArray Meningitis/Encephalitis Panel
BioMérieux, a world leader in the field of in vitro diagnostics, has announced that BioFire, its molecular biology affiliate, has submitted a de novo classification request to the FDA for the FilmArray Meningitis/Encephalitis (ME) Panel. The pioneering FilmArray ME Panel addresses a critical, unmet need for quickly identifying central nervous system infections by utilizing a comprehensive panel to test cerebrospinal fluid (CSF) for the most common bacteria, viruses and fungi responsible for ...
Posted on: April 23, 2015
FDA Clears the Simplexa Group A Strep Direct Test from Quest's Focus Diagnostics
Focus Diagnostics, the clinical-laboratory products business of Quest Diagnostics, 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 common in children aged 5-15. More than ...
Posted on: April 22, 2015
New Live Education Meeting Expands Cytotechnologists' Skills to Stay in Demand
Without the proper training and updating of skills, cytotechnologists will be left behind because their current training and scope of practice may not allow them to keep up with the growing demands in the cytopathology field. ASCP and the American Society of Cytopathology (ASC)-the two premier providers of cytopathology education-are proactively addressing the current and future needs of the cytopathology community.On June 13-14, 2015, ASCP and ASC will present Advanced Cytopathology Education (ACE), ...
Posted on: April 21, 2015
Beckman Coulter Broadens Menu with Immunosuppressant Drug Reagents
Beckman Coulter Diagnostics will now distribute four new Immunosuppressant Drug (ISD) user defined reagents as part of the company's Therapeutic Drugs Monitoring menu on its AU family of clinical chemistry systems. The assays, manufactured by Thermo Fisher Scientific, will enable laboratories to deliver vital results for the management of immunosuppressant drug therapy for organ transplant patients-specifically aiding in the management of kidney, liver and/or heart transplant patients. The assays included ...
Posted on: April 20, 2015
Inmark Announces Acquisition of Saf-T-Pak
Inmark, a leading provider of global packaging and services, has announced that their acquisition of Saf-T-Pak, a specialized provider of regulatory training and packaging for the safe transport of infectious substances, was effective April 7, 2015. For over 20 years, Inmark has been a leader in Life Sciences packaging supply and compliance training. The acquisition of Saf-T-Pak will increase Inmark's portfolio to include an expanded line of infectious substance packaging solutions, training software and ...
Posted on: April 20, 2015
COLA Convenes Online Community to Advocate for Lab Quality
COLA, a leading laboratory accreditor, launched a new website, www.labtestingmatters.org, a community for laboratorians, allied health professionals and patients alike, to exchange ideas and experiences demonstrating the importance of quality laboratory medicine. COLA is launching the new online community to coincide with the 40th anniversary of Medical Laboratory Professionals Week (MLPW), an annual observance designed to educate healthcare professionals, the public, and others ...
Posted on: April 17, 2015
Seegene Forms U.S. Subsidiary to Drive Growth in Molecular Diagnostics Market
Seegene Inc., a leading developer of multiplex PCR technologies, today announced the establishment of a new U.S. subsidiary, Seegene Technologies Inc., in Concord, Calif., from which it will focus on growing its presence in the rapidly evolving global molecular diagnostics market.Seegene plans to enhance its sales channel in the U.S. by directly managing its existing clients and further expanding its client base through Seegene Technologies. As part of initiatives to expand its global presence in the ...
Posted on: April 16, 2015
Adaptive Biotechnologies' clonoSEQ Minimal Residual Disease Test Predicts Relapse in Diffuse Large B-Cell Lymphoma Patients
Adaptive Biotechnologies has announced publication of a study in The Lancet Oncology showing that analysis of circulating tumor DNA (ctDNA) using the company's next-generation sequencing-based minimal residual disease (MRD) detection and quantification technology (available clinically as the clonoSEQ MRD test) accurately identifies patients with diffuse large B-cell lymphoma (DLBCL) who are at risk of relapse after initial treatment, usually several months before disease can be detected via computed ...
Posted on: April 15, 2015
Ariosa's Harmony Prenatal Test Shown Superior to Conventional Pregnancy Screening for Down Syndrome in Largest Clinical Trial
Results from the largest clinical trial to date, comparing non-invasive prenatal testing (NIPT) using the Harmony Prenatal Test with conventional first trimester combined screening (FTS) in a general pregnancy population have been published online in The New England Journal of Medicine (NEJM). The NEXT (Non-Invasive Examination of Trisomy) Study demonstrates statistically significant superiority of the Harmony Prenatal Test over FTS for accurately assessing the risk of Trisomy 21 which causes Down ...
Posted on: April 14, 2015
Alere Receives FDA Clearance for Alere(TM) i Strep A Rapid Molecular Test
Alere Inc., a global leader in rapid diagnostic tests, has announced that its Alere i Strep A test has received marketing clearance from the FDA. Alere i Strep A is the first molecular test that detects Group A Streptococcus (GAS) bacteria in throat swab specimens in 8 minutes or less.Upon receipt of this clearance from the FDA, Alere submitted an application for CLIA waiver of the Alere i Strep A test. Other assays currently in development on the Alere i platform include respiratory syncytial virus ...
Posted on: April 13, 2015
OCEASOFT Unveils Single-Use Tool to Track Temperature during Cold-chain Shipping via Portable Devices
OCEASOFT, a global provider of sensor-based solutions for monitoring environmental parameters, today announced a unique, single-use temperature-tracking tool whose measurements can be read through isotherm wrapping or container walls via smartphones and tablets using Bluetooth technology. The OCEASOFT Atlas module is designed to meet a growing demand for an inexpensive, disposable temperature tracker that allows users to improve quality control, while managing costs better. It both ...
Posted on: April 12, 2015
Quintiles and Quest Diagnostics to Form Joint Venture to Provide Global Clinical Trials Laboratory Services
Quintiles and Quest Diagnostics have announced a definitive agreement to form a global clinical trials laboratory services business. By combining the clinical trials laboratory operations of two industry leaders, the new entity will provide customers with the depth of capabilities and end-to-end clinical trial laboratory services required to succeed in the increasingly complex biopharmaceutical industry. The new entity will offer a compelling value proposition to solidify its position as the ...
Posted on: April 10, 2015