This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: COBAS® AmpliPrep/COBAS® TaqMan® CMV Test
PMA Applicant: Roche Molecular Systems, Inc. (RMS)
Address: 4300 Hacienda Drive, Pleasanton, CA 94588
Approval Date: July 5, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf11/p110037a.pdf
What is it? The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is a laboratory test used to measure the amount of Cytomegalovirus (CMV) DNA in a patient’s plasma. Viral DNA is the genetic material from CMV.
CMV is a human viral pathogen; it is globally distributed, and can be transmitted through blood and other body fluids. Primary infections with CMV in immunocompetent individuals are usually asymptomatic and often give rise to undetected, latent infections. Immunocompromised solid-organ transplant patients are at high risk for developing severe CMV infections that can lead to morbidity and mortality. In this patient population, the individual’s CMV viral DNA load is measured during antiviral treatment to assess their virological response to the treatment.
This test is designed for use on the COBAS® AmpliPrep/COBAS® TaqMan® System, which runs the assay and analyzes the results.
How does it work? A sample of the patient’s blood is obtained and sent to a clinical laboratory. The blood sample is processed to obtain plasma. Nucleic acid (DNA) in the plasma sample is automatically separated and purified from the plasma sample using the COBAS® AmpliPrep instrument. Separated and purified DNA is mixed with the assay reagents and the resulting mixture is placed into the COBAS® TaqMan® Analyzer. The COBAS® TaqMan® Analyzer calculates the amount of CMV DNA in the patient’s plasma based on the amount of produced light measured by the analyzer after completion of the reaction.
Measurement of the amount of CMV DNA in the plasma, together with clinical information and other laboratory findings, are used by physicians to help determine an individual’s virological response to treatment.
When is it used? This test is used together with clinical information and other laboratory results in solid-organ transplant patients to make serial CMV DNA measurements to assess the response to treatment for CMV.
What will it accomplish? Test results, in combination with clinical information and other laboratory tests, can be used to help assess an individual’s virological response to treatment and aid in the management of solid-organ transplant patients undergoing antiviral therapy.
When should it not be used? The COBAS® AmpliPrep/COBAS® TaqMan® CMV Test is not intended for use as a screening test for the presence of CMV DNA in blood or blood products.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.