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FDA Approval for Roche’s Cytomegalovirus Viral Load Test

5 Jul 2012
Sonia Nicholas
Managing Editor and Clinical Lead

Product news

Roche Molecular Diagnostics has announced that it has received premarket approval from the U.S. Food and Drug Administration (FDA) for a new test to assess a patient’s viral load of cytomegalovirus (CMV).

CMV is the most common and important viral infection in solid organ transplant recipients. The virus can be transmitted through the donor organ, resulting in CMV infection and leading to the development of CMV disease, or can occur by reactivation of the virus in transplant recipients with previous CMV infection.

The fully automated COBAS® AmpliPrep / COBAS® TaqMan® CMV Test is the first FDA-approved laboratory test for use in quantifying CMV DNA in human plasma specimens. Physicians use CMV DNA viral load information from the test to help manage patients who have been diagnosed with CMV disease, specifically patients whose immune system has been suppressed for solid organ transplantation.

“We are pleased to offer this innovative test to address a key medical need for immunosuppressed solid organ transplant patients,” said Paul Brown, Ph.D., head of Roche Molecular Diagnostics. “With this test, laboratories now have an FDA-approved option for standardized and automated CMV viral load testing that improves the laboratory’s workflow. It provides physicians with clinically useful information to aid in the management of solid organ transplant patients with CMV disease.”

Roche’s new real-time polymerase chain reaction (PCR)-based CMV test is designed for use on the fully automated COBAS® AmpliPrep/COBAS® TaqMan® System, an established platform for viral load monitoring of multiple infectious diseases. The system can be combined with the cobas p 630 Instrument, which provides an integrated pre-analytical primary tube handling solution.

Roche expects to begin shipping the new CMV test kit in the U.S. in August 2012.

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Genome AnalysisGenomics, the study of genomes, includes functional genomics, evolutionary genomics and comparative genomics. There are many genomic technologies such as DNA sequencing of whole genomes, computational biology and bioinformatics. DNA and nucleic acids must be isolated and concentrated from cells for analysis with kits, automated analyzers and software. Other useful technologies for studying genomics include PCR, microarrays and electrophoresis.PCR and Thermal CyclingPolymerase chain reaction (PCR) kits and thermal cyclers are used for the in vitro amplification of DNA permitting subsequent analysis and experimental procedures. Explore a range of high-quality polymerase, primers and nucleotides or simplify your workflow with a PCR mastermix. Find reverse transcription PCR (RT-PCR) and cDNA synthesis kits for RNA products and libraries. Quantitatively measure the amplification of DNA with real-time PCR (qPCR) and droplet digital PCR (ddPCR) kits and systems, and discover automated PCR setup solutions to increase throughput. Alternative DNA amplification methods also include recombinase polymerase amplification (RPA) kits. Find the best PCR kits and thermal cyclers and purification equipment in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Blood TransfusionBlood Transfusion involves giving donor blood to a recipient patient. Screening is essential to avoid transfusion reactions. Blood banks use immunohematological techniques to determine rh and ABO blood group, and screen for antibodies using specific antisera. Blood Banks use Direct Coombs Tests (DCT) and Indirect Coombs Tests (IAT) to detect hemolysis and Haemolytic Disease of the Newborn (HDN).ImmunologyImmunological techniques measure and characterize immune responses. Immunology kits and analysis systems often use techniques such as ELISA, radioimmunoassay (RIA) and immunodiffusion assays, Immunohistochemistry, and flow cytometry. Immunologists use equipment such as flow Cytometers, plate readers, plate washers and fluorescent microscopes.Clinical MicrobiologyMicrobiology is the study of microorganisms including protists, prokaryotes, fungi, and, often, viruses. Microorganisms are a useful research tool as genetic vectors and, in immunology, for antibiotic susceptibility testing, cellular biology and genetics. Microorganisms commonly grow readily in incubators with microbial culture media; this can contain chromogenic supplements to differentiate between cell lines. Estimate your culture’s density of microorganisms with colony counters, or screen and select colonies for desirable clones with automated colony pickers. Additionally, equipment is available to monitor environments for the presence of microbes and identify with microbial identification instruments. Find the best microbiology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Transplant MonitoringCMVVirusesViruses are microscopic pathogens that require a host cell to replicate. Understanding their structure, replication cycle, and impact on the immune system is crucial in developing effective treatments, vaccines, and diagnostic methods. Research continues to focus on emerging viral diseases and antiviral drug discovery. Explore solutions for virus research, detection, and treatment in our peer-reviewed product directory; compare products, check customer reviews, and get pricing directly from manufacturers.

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FDA Approval for Roche’s Cytomegalovirus Viral Load Test