Delivering results in less than 2 hours, the Xpert ebola test has been authorized for use by CLIA moderate- and high-complexity laboratories or similarly qualified non-US laboratories.
In written comments to FDA, the Association for Molecular Pathology argues that the agency should refrain from regulating the design, validation, and interpretation of next-generation sequencing procedures.
CLP spoke with Roger D. Klein, MD, JD, FCAP, medical director for molecular oncology at the Cleveland Clinic, and chair of the Association for Molecular Pathology ’s professional relations committee, to find out more about AMP’s revised policy on direct-to-consumer genetic testing,
PositiveID Corp has completed a first round of testing for its handheld, real-time polymerase chain reaction-based pathogen detection system, which reportedly delivers positive results within 20 minutes.
Under a new agreement, Biodesix and Inivata will investigate the clinical utility of blood-based next-generation sequencing tests for patients with non-small cell lung cancer.
The new partnership will focus on creating a universal test system for clinical trials of targeted cancer therapies, with the goal of developing a more comprehensive tool for precision medicine.
Data from the ongoing NBRST trial suggest that Agendia’s BluePrint 80-gene molecular subtyping assay more accurately identifies molecular subgroups and may be a better guide for neoadjuvant chemotherapy than IHC/FISH assays.
A new collaboration focused on digital pathology enhances cutting-edge capabilities to improve workflow and reliable, consistent processes.
In a study of breast biopsy interpretations, concordance between individual pathologists and an expert consensus panel was just 75%, suggesting a need for a formal second opinion in many cases.
Two studies confirm that the great versatility of viruses can result in deaths, and requires continued receptor-binding and structural studies.
The collaboration leverages grants from the Bill & Melinda Gates Foundation and Paul G. Allen Family Foundation to automate rapid ebola testing and increase access to reliable data from the field.
Enumeral performs measurements on single immune cells from patient-derived biopsy samples, for information that may guide the development of effective therapeutics and diagnostics.
Exact Science scores a big hit, notching Cologuard coverage from two major U.S. payors.
In a multicenter study, the combined platform test by Interpace Diagnostics achieved negative predictive value of 94% and positive predictive value of 74%.
Featured products include the EXCM mini H-gantry from Festo, the Firefly Dx ebola detection system, and the i.Series ultra-low freezer line from Helmer Scientific.
Experts from the clinical lab community gathered on January 8–9, 2015, to comment on FDA's proposed regulatory structure for laboratory-developed tests. This selection of comments from the first day of the workshop offers a glimpse into the depth of participants’ observations.
JAMA study data suggest that the American Thyroid Association's recommendation for indication of repeat cytology should be revised.
Selah Genomics, Greenville Health System, DecisionQ Corp, and BD have agreed to work together to “democratize genetic medicine.”
A Miami Breast Cancer Conference study and workshop have reinforced the clinical utility of bioTheranostics’ Breast Cancer Index for informing decisions about long-term endocrine therapy and assessing risk of late recurrence.
With the new contract, more than four million members across over 200 payor clients gain access to Combimatrix’s diagnostic solutions and clinical support.