Oxford Immunotec Limited Release: American Medical Association Establishes a New CPT(R) Code for Use with the T-SPOT(R).TB Test
Published: Dec 20, 2010
The new Category I code, 86481, is described as “Tuberculosis test, cell mediated immunity antigen response measurement; enumeration of gamma interferon-producing T-cells in cell suspension.” This new code will be effective as of January 1, 2011.
The T-SPOT.TB test is based on a patented enzyme-linked immunospot (ELISpot) technology which is a highly accurate and innovative way to measure T-cell response. The T-SPOT.TB test measures the patient’s immune response to T-cells that have been sensitized to Mycobacterium tuberculosis, the bacterium that causes tuberculosis infection.
The T-SPOT.TB test received premarket approval from the Food and Drug Administration (FDA) in July 2008. The test is backed by the clinical evidence of over 200 peer-reviewed publications, and is the only TB screening test with sensitivity and specificity exceeding 95% in FDA pivotal trials. The T-SPOT.TB test has become widely utilized in hundreds of hospitals, medical practices and public health facilities throughout the United States.
Commenting on the new code, Dr. Peter Wrighton-Smith, CEO of Oxford Immunotec, said, “By choosing the T-SPOT.TB test, our customers have shown their trust in our test and the technology platform upon which it is run. I am pleased that the American Medical Association agrees that the ELISpot platform is a unique and powerful technology. The establishment of this new code will improve access to the test and make it more available to physicians and hospitals.“
About Oxford Immunotec
Oxford Immunotec Ltd., the T cell measurement company, is headquartered near Oxford, UK; its US operations are based in Marlborough, MA. The company develops and sells clinical diagnostic products based on its patented T-SPOT(r) technology, the first FDA-approved method for directly quantifying antigen-specific T cells.
T-SPOT technology is a simple and extremely accurate method of studying a person’s cellular immune response to infection and could be applied to diagnose and monitor any major disease driven by a T cell response.
About T-SPOT®.TB test
The T-SPOT.TB test is an in vitro T cell measurement assay used for diagnosing TB disease and latent TB infection and is the first product from Oxford Immunotec using T-SPOT technology. The product offers unrivalled sensitivity with results unaffected by a patient’s immune status. The T-SPOT.TB test is approved for sale in Europe, USA, Canada and over 40 other countries worldwide and is designed to replace the 115 year old tuberculin skin test. It offers a substantially more accurate and effective tool for control l ing the spread of TB, addressing a market exceeding $1bn.
T-SPOT and the Oxford Immunotec logo are trademarks of Oxford Immunotec Ltd.
CPT is a registered trademark of the American Medical Association