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There’s reason to be both optimistic and pessimistic about the United States IVD market, depending on what sectors one wishes to focus on.  Despite persistent challenges to the U.S. in vitro diagnostics (IVD) market, advanced testing segments can lead a bounce-back delivering growth to test innovators—suppliers and labs alike. Chief among recent disappointments in U.S. IVD market performance has...
The point-of-care testing market can expect significant growth
Point-of-care testing (POCT) is among the fastest-growing areas of laboratory medicine, driven by clinicians’ increased need for technologies that are faster, cheaper, and provide more robust, clinically useful results than ever—a need fueled more recently by the ongoing restructuring of U.S. healthcare through the Affordable Care Act (ACA). The POCT market is projected to grow to $27.5 billion by 2018...
The growth of genomic medicine has cast a spotlight on the need for higher-resolution technologies for chromosomal analysis. [© fotohunter/iStock]
Detection and analysis of structural variability within chromosomes have become an integral part of genomic medicine. Because genomic instability and chromosomal abnormalities characterize cancer as well as many developmental diseases, understanding these structural aberrations can provide insight into disease etiology, treatment options, and prognosis. According to physicians, current cytogenetic tests for developmental diseases tests, including G-banded chromosome analysis and fluorescence...
Each year millions of babies are routinely screened for certain genetic
Thirteen years after the completion of the Human Genome Project, an increasing number of genomic applications, including next-generation sequencing (NGS), are poised for clinical use. Fulfilling the promise of genomics to improve health in the real world requires a public health perspective. As genomics reaches the bedside, a public health “post bedside” research agenda will be able to assess the...
Exome sequencing has promise in oncology testing
Next-generation sequencing (NGS) not only continues to make steady advances in the molecular diagnosis of cancers, it also seems to fit perfectly with our current knowledge of the oncogenome. In particular, by making it possible to screen the entire coding sequence of cancer-related genes, NGS overcomes a key problem—cancer predisposition cannot be monitored by just a few hotspot mutations. The...
Cologuard is designed to analyze DNA alterations and blood in the stool to detect the presence of colon cancer and precancers. [Exact Sciences]
Exact Sciences has won FDA approval for the first noninvasive DNA screening test for colorectal cancer—the first stool-based diagnostic designed to indicate the presence of abnormal growths in red blood cells and DNA mutations, and the first test to be approved under a joint parallel review pilot program by the agency and the Centers for Medicare and Medicaid Services...

The eighth issue of Clinical OMICs is available now! Check it out by clicking on the link below.

A genomic analysis of tumors from 12 tissues of origin reveals a new classification system. It consists of 11 subtypes that appear to reflect the cell type of origin. [Zhong Chen
Advancing the work of The Cancer Genome Atlas (TCGA), a large team of researchers from multiple institutions performed a comprehensive analysis of molecular data from thousands of patients representing 12 different types of cancer. The analysis pointed to an alternative system for classifying cancer. Instead of defining cancers according to their tissues of origin, the new system considers molecular...
The CVD space is an attractive segment wherein POC diagnostics finds significant utility. [© Alexander Raths - Fotolia.com]
The focus of this GEN Market & Tech Analysis report is to present some of our recent industry tracking of the point-of-care diagnostics (POCD) space. Highlights: We present the POC diagnostics space with emphasis upon cardiovascular disease (CVD) in this report. The growth of the POC space is exponential and its impact on CVD cannot be ignored. CVD is an optimal therapeutic area...
Scientists from McGill University and the Génome Québec Innovation Centre say they have achieved a technical advance that could result in speedier diagnosis of cancer and various prenatal conditions. Their discovery, which is described online (“Convex lens-induced nanoscale templating”) in the Proceedings of the National Academy of Sciences (PNAS), lies in a new tool developed by Sabrina Leslie, Ph.D.,...

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