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Like many other diagnostic regimes that were previously restricted to large specialty laboratories, genetic analysis has entered the clinical mainstream. Smaller, simpler analyzer systems are now suitable and affordable for hospitals or laboratories associated with physicians’ groups, and many companies are currently invested in developing point-of-care (POC) genetic tests. Spartan Bioscience Inc. (Ottawa, Ontario, Canada) announced in January 2013 that it had submitted the first POC genetic test (Spartan RX CYP2C19 Genetic Test) to the FDA for 510(k) regulatory clearance.*
Gene Analysis and Molecular Diagnostic Systems
Genetic analysis systems (GAS) now comprise not only sequencing and genotyping, but also narrower applications such as molecular diagnostics. The broader applications include de novo sequencing; mutation/heterozygote detection; single nucleotide polymorphism genotyping; analysis of microsatellites, amplified fragment length polymorphisms, methylation, and terminal restriction fragment length polymorphisms; multilocus sequence typing; bacterial artificial chromosome fingerprinting; and DNA sizing. Molecular diagnostics has evolved from simple diagnosis to more complex determinations, such as identifying clinically relevant resistance mutations as well as interpreting genotypes and subtypes.
- Life Technologies Corporation (Grand Island, NY) offers a range of genetic analyzers from Applied Biosystems®. They range from the ABI PRISM® 310 Genetic Analyzer, an automated single-capillary genetic analyzer for academic and forensic laboratories that use genetic analysis but perform a few reactions a day, to flexible, upgradeable analyzers, including multicapillary analyzers capable of a few million reactions per day. Kits, assays, standards, reagents, accessories, purification equipment, and software are available for these sequencers.
- Cepheid (Sunnyvale, CA) offers the GeneXpert® System, a closed, self-contained, fully integrated platform. By automating the entire testing process and using a closed cartridge, the GeneXpert System will expand genetic testing beyond the confines of hospital and laboratory settings. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences, thereby delivering answers directly from unprocessed samples. The company also now offers the GeneXpert Infinity Systems, which allow a comprehensive menu of tests that can be run on a single system, by a single operator, in a moderately complex laboratory. There are two sizes: The Infinity-48s can perform greater than 1300 tests per day, and the Infinity-80 can perform over 2000 tests per day. The tests include infectious disease detection for Mycobacterium tuberculosis complex DNA and rifampin-resistance-associated mutations of the rpoB gene, Clostridium difficile and the epidemic 027 strain, influenza A and B, and other organisms, along with an assay for BCR-ABL, the fusion gene in chronic myelogenous leukemia.
- Siemens Healthcare Laboratory Diagnostics (Malvern, PA) offers the OpenGene® DNA Sequencing System. The OpenGene system consists of hardware, software, and chemistry for assessing HIV resistance and identifying the genotype. The TRUGENE® HIV-I Genotyping Assay incorporates bi-directional sequence data for codons in the protease and reverse transcriptase regions of the viral genome, and the interpretative algorithmic software determines the clinical relevance of HIV mutations, identifying those that confer resistance to specific types of antiretroviral drugs. In addition, TRUGENE HIV has an algorithm validated by an independent panel of HIV experts, providing regular updates, which are cleared by the FDA prior to release.
Siemens also offers the Transcription-Mediated Amplification (TMA) Component System for detecting HCV RNA. The modular system has flexible throughput, generating up to 100 test results in less than 5 hr. The TMA component system is used with the VERSANT® HCV RNA Qualitative Assay, which has a limit of detection of 5.3 IU/mL. The company claims that its assay is the most sensitive assay currently approved by the FDA for the detection of HCV.
*For more information see: http://www.prweb.com/releases/2013/1/prweb10303744.htm.
Please see our Automated DNA Sequencer / DNA Sequencing System section to find manufacturers that sell these products