Molecular Diagnostic Testing
Process controls to assess and monitor workflow process
KRAS FFPE Process Controls enable laboratories to assess and monitor workflow from FFPE sample to result without using archived tumor material. They are designed to emulate FFPE samples through all steps of the workflow process including deparaffinization and extraction. The kit comprises controls for seven KRAS gene mutations: G12A, G12C, G12D, G12R, G12S, G12V, and G13D, as well as a wild type (WT) control. KRAS FFPE Process Controls are manufactured by formalin-fixing and paraffin-embedding a synthetic tissue that contains KRAS mutation-positive cells. They are manufactured in accordance with ISO 17511 for consistent performance across lots. The kit consists of eight vials, each containing a 10 µm FFPE tissue section created from cells harboring a single mutation; each 10 µm section contains >200 ng of DNA. This product is for research use only and not intended for human therapeutic or diagnostic use.
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New Simplexa Flu/RSV Test Launched in Europe
The Simplexa Flu A/B & RSV Molecular Test on the 3M Integrated Cycler uses a proprietary technique that eliminates the need for nucleic acid extraction, a time consuming, technically challenging process required of most molecular test products. The test detects influenza A, B, and respiratory syncytial viruses, and is now CE marked and available in Europe.
Visit Focus Diagnostics
Automate (F)ISH testing
The ThermoBrite Elite Automated Laboratory Assistant automates the pre- and post-hybridization steps in (F)ISH testing and provides on-board denaturation and hybridization while maintaining temperature control at ±1oC. Twelve slides can be processed per run. It offers time-saving, walk-away convenience. An easy-to-use interface offers standard protocols for blood, urine, or solid tumor (F)ISH procedures and can be customized for other tests. Up to 10 reagents can be dispensed. Three independent waste ports for proper disposal are available. The small bench-top unit provides consistency and reproducibility in (F)ISH Âtesting.
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DNA analyzer with upgraded features
The INFINITI® Plus Analyzer offers faster run time and larger capacity than its predecessor. Designed to integrate and automate all the discrete steps in DNA analysis, the new system can process up to 48 samples in 5.5 hours. The INFINITI® Plus Analyzer is compatible with all 50 INFINITI® applications currently available, including HPV-HR, Bacterial Vaginosis, and Candida Vaginitis tests for Women’s Health; CYP2C19, CYP2D6, and Warfarin assays for Pharmacogenomics; KRAS and BRAF tests for Oncology; and ApoE, Cystic Fibrosis, and Factors assays for Genetic Disorders.
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Mutation coverage
The xTAG Cystic Fibrosis Kit is for cystic-fibrosis genotyping. With validated performance criteria, this highly accurate and reproducible (>99.9%) assay gives wide mutation coverage for carrier screening in adults and aid in the diagnosis in newborns.
Luminex
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Carrier detection
The
eSensor CF Carrier Detection System offers highly accurate and
reproducible cystic-fibrosis-carrier results delivered in an
easy-to-interpret report. Each kit includes all reagents necessary
for PCR amplification and mutation detection in a single box.
Reports include a summary "carrier" or "non-carrier."
Osmetech
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Comprehensive test
CF
AMPLIFIED is a comprehensive CF test, detecting approximately
99% of mutations, including gross deletions and duplications, in
patients of all ethnicities. The test begins with full gene sequence
analysis detecting 97% to 98% of mutations. Testing is done in steps
to control costs and the average turnaround time is reduced from 15
to 35 days to 14 to 28 days.
Ambry Genetics
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Detect and identify
The
InPlex CF Molecular Test has an easy multiplex format with few
steps and few repeats, no necessary reflex testing, and very little
hands-on time. After extraction, results are achieved in four hours
or less. Low start-up costs, low hands-on time, fast time to
results. Runs with common lab equipment and common extraction
methods.
Third
Wave Technologies
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Direct sequence analysis
The
full CF Gene Sequencing Test is direct sequence analysis of
the CFTR gene, identifying every nucleotide of all 27 exons, their
associated splice site regions, and clinically relevant regions of
introns that contain disease-causing mutations. Also offered is
partial CF-gene sequencing for families with known mutations not
detectable in a general screening assay.
Genzyme
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Expanded panel
The
CF70 Genotype is a 70-mutation screening panel for
cystic-fibrosis carrier, pre-natal, and diagnostic testing. The
broad mutation coverage of the CF70 Genotype exceeds the minimum
recommendations of the American College of Medical Genetics and the
American College of Obstetricians and Gynecologists for general
population screening.
Specialty Labs
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Detect over 70 strands
A
new molecular test is available for enterovirus. This
quantitative test detects more than 70 strains of enterovirus, and
also assists in determining and tracking the severity of the
infection by measuring a patient's viral load. Results are
guaranteed within 24 hours.
ViraCor
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Enhanced capabilities
The
TRUGENE HIV-1 Genotyping Kit and OpenGene DNA Sequencing
System are now supported by the Apple iMac OSX operating
system. This system provides an integrated computational system that
delivers enhanced data management, simplified system configuration,
network support, and increased flexibility and throughput.
Siemens Medical Solutions Diagnostics
www.rsleads.com/807ml-161
Real-time flu test
The
ProFlu+ is a real-time molecular biology test for respiratory viruses that
gives results in as few as three hours. It employs a multiplex platform that
allows several tests to be processed using the same sample to detect influenza A
virus, influenza B virus, and respiratory syncytial virus A and B (RSV).
Prodesse
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