Genomics and proteomics
DNA-extraction instrument
The AutoGenFlex STAR Automated DNA Extraction Instrument features a protocol optimized for this company’s FlexiGene chemistry to isolate highly pure DNA from 40 samples of up to 10 mL each human whole blood and produce 25 µgs to 40 µgs per mL. Featuring a hand-held bar-code scanner for the automated population of sample data, this fully automated, walkaway system has a built-in centrifuge, gripper-type robotic handling, and removable sample- and DNA-storage racks. Providing sample tracking with bar-code identification and reporting software, the instrument can isolate DNA from whole blood, buffy coats, tissues, cells, buccal swabs, Oragene saliva, and more.
Autogen
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Detect up to 99% mutations for diabetes diagnosis
The RCAD AMPLIFIED Test is the only clinical test available in North America with gene sequence and gross deletion analysis to detect up to 99% of mutations. A significant fraction of prenatally detected, neonatal, and pediatric renal structural abnormalities are caused by complete or partial deletions of the TCF2 gene (also called HNF1B), which can also cause maturity-onset (or MODY5) diabetes. This test includes concurrent full gene sequence analysis and gross deletion/
duplication analysis. Prenatal testing is also available. Turn around time is 10 to 21 days. Kidney defects include cysts, dysplasia, and single kidney. These gross deletions of the TCF2 gene are not detectable by traditional sequencing methods. Rearrangements detected incidentally in genes other than TCF2 can be reported by request.
Ambry Genetics
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Detect, measure HIV-1, genetic variations of virus
The RealTime HIV-1 assay, for use on the m2000 system by this company, is among the most sensitive viral load tests available, with a broad dynamic range, capable of quantitating HIV-1 in plasma down to as few as 40 RNA molecules per milliliter (mL) and up to as many as 10 million molecules per mL. This assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of disease prognosis. It is also used as an aid in assessing viral response to antiretroviral treatment as measured by changes in plasma HIV-1 RNA levels and to detect and precisely measure levels of HIV circulating in a patient’s blood, including the three major groups of HIV-1 as well as non-B subtypes.
Abbott Molecular
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DNA/RND autoextraction for one to 16 samples
New to molecular diagnostics? The Maxwell 16 is a productivity-enhancing, automated nucleic-acid purification instrument, with broad acceptance in the clinical market segment. This system offers walk-away nucleic-acid extraction and recombinant-protein purification. It delivers consistent results from a variety of clinical samples, including FFPE, blood, buffy coat, swabs, and more. The Maxwell 16 system brings personal-automation technology to low- to moderate-throughput DNA and RNA extraction. Using this tool, clinical laboratories can improve efficiency while ensuring consistent results. Extracts samples in 30 to 45 minutes, provides optimized automated DNA and RNA extraction for one to 16 samples, and removes technician-to-technician variability by eliminating manual methods. The system also processes up to 16 samples in 30 to 45 minutes.
Promega Corp.
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Simple closed-tube real-time PCR test
The eQ-PCRT LC Warfarin Genotyping Kit is an
in vitro
diagnostic test for genotyping single nucleotide polymorphisms (SNPs) in the cytochrome P450 enzyme gene CYP2C9 known as CYP2C9*2 (C430T), CYP2C9*3 (A1075C), and an SNP in the vitamin K epoxide reductase complex 1 gene (VKORC1) known as VKORC1 (-1639G>A). The tests use genomic DNA extracted from whole blood, and the genotype detections are performed on real-time PCR systems made by Roche. The kit is designed for use in clinical laboratories upon prescription by the attending physician. The test uses the melting-curve method to identify three SNPs. The procedure is similar to the Factor V Leiden test; 1.5 hours for 14 samples (one run).
TrimGen Corp.
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Whole genome tumor profiling for prostate cancer
CombiMatrix’s Prostate Cancer Microarray Test is the first prostate-cancer array-based test and an initial step toward introducing the concept of genomic pathology through this company’s platform of array CGH (comparative genomic hybridization). By enabling a more precise stratification of the risk profile of prostate cancer patients, the test provides a valuable new tool to physicians and patients. This offers the potential for making informed decisions about the benefits and risks of whether or not to treat their prostate cancer and, if so, in what manner. The test probes for specific genomic loci for which copy number gains and losses have been shown to correlate with risk of recurrence and metastasis in patients post-prostatectomy.
CombiMatrix
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Powerful software tool for genetic analysis
Mutation Surveyor, a tool for DNA variant analysis from sequence traces is available in two batch processing capacities (400 and 48 traces per batch), uses patented anti-correlation technology to provide highly accurate discovery of DNA Variants from Sanger Sequencing traces. Compatible with outputs from many widely used systems, Mutation Surveyor rapidly locates all variants and SNPs and Indels between reference traces and sample/patient traces with excellent accuracy and sensitivity. The program runs on Windows operating systems, and has a myriad of reporting capabilities for diagnostics applications. Some capabilities include detection sensitivity and accuracy, methylation analysis, whole gene assembly, and unattended operation.
SoftGenetics
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Detect all 13 high-risk HPV types
The digene High-Risk HPV hc2 Test is an in vitro nucleic acid hybridization assay that utilizes antibody capture and qualitative chemiluminescent signal detection of HPV types based on signal amplification. The test is suitable for high- or low-volume testing applications. The test uses an RNA probe cocktail to detect all 13 high-risk HPV types which are highly carcinogenic. It analyzes HPV DNA high-risk groups in cervical specimens, and has been approved for use with hc2 DNA Collection Device, HC Cervical Sampler, Specimen Transport medium, and Cytyc ThinPrep Pap Test PreservCyt Solution. This test has the highest clinical sensitivity proven by extensive clinical validation.
QIAGEN
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Lab offers diagnosis of tumors of unknown origin
The Pathwork Tissue of Origin Test is available through a CLIA-certified diagnostics laboratory. When there is uncertainty about a tumor’s origin, the Tissue of Origin Test can help fill the information gap with accurate, objective, actionable information. Physicians can order the test when the cancer is found in an unexpected location; the tumor cells are poorly differentiated or undifferentiated, making them difficult to interpret; the cancer is found in multiple locations, or is indicating metastatic disease without a clear primary. This lab provides a comprehensive service for the preparation and analysis of samples. Proprietary analytics are used to interpret the data, and a report is generated that provides clear, objective information on the Similarity Score for each tumor type.
Pathwork Diagnostics
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