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Oxford Immunotec Limited RT-SPOT.TB Receives Regulatory Approval and Reimbursement Coding in Japan


11/13/2012 11:58:01 AM

Oxford, UK and Kawasaki, Japan; November 13, 2012 – Oxford Immunotec, a medical diagnostic company developing tests in the fields of infectious and immunological disease, today announced that the T-SPOT® .TB test has received regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW). The T-SPOT.TB test is a laboratory based cellular blood test that is intended for use as an aid in the diagnosis of Mycobacterium tuberculosis infection and disease. The T-SPOT.TB test improves accuracy and eliminates the logistical challenges often seen with the existing tests for TB infection.

Clinical studies were performed in Japan to obtain this approval. In these studies the test sensitivity (positivity in infected subjects) was 97% and the test specificity (negativity in non-infected subjects) was 99%.

Oxford Immunotec also announces the inclusion of T-SPOT.TB in the clinical lab fee schedule of reimbursed tests and into the public health government subsidy for contact tracing.

Commenting on the approval, Dr Peter Wrighton-Smith, Chief Executive Officer of Oxford Immunotec, said, “Japan has one of the highest TB rates in the developed world and the accurate and reliable identification of tuberculosis infection, possible with the T-SPOT.TB test, will be an important component of helping to reduce TB rates there.” He continued “Japan has been one of the last major developed-world countries in which we have received regulatory approval. T-SPOT.TB is now sold in over 40 countries worldwide ”.

About Oxford Immunotec

www.oxfordimmunotec.com

Oxford Immunotec Ltd., a global immunology-focused diagnostic company, is headquartered near Oxford, UK; with US operations in Marlborough, MA and Memphis, TN and Japanese operations in Kawasaki, near Tokyo. The company is developing novel tests in the fields of infectious and immunological disease based primarily on its patented T-SPOT® 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 and, as such, provides a unique methodology to diagnose and monitor diseases driven by a T cell response.

Oxford Immunotec’s primary product, the T-SPOT.TB test, is one of two Interferon-gamma release assays (IGRAs) which detect latent TB infection and are replacing the 90-year old tuberculin skin test currently used for this purpose. The World Health Organisation [1] estimated in 2006 that 50 million latent TB screening tests were performed each year, representing a greater than $1bn per annum market opportunity for TB testing globally. IGRAs are now endorsed in clinical guidelines in over 20 countries and the T-SPOT.TB test has now received regulatory approval in over 40 countries worldwide, including the US, Europe, Canada, Russia, Korea and China. In Japan, the T-SPOT.TB test is covered by reimbursement code D015 25 TB (Specific Interferon-? release ability) at a rate of ¥6,300 (approximately $80/test). The T-SPOT.TB test is also covered in various other clinical lab fee schedules around the world, including the US where it has its own unique CPT code (86481).

As well as developing and selling tests in kit form, Oxford Immunotec also runs a testing laboratory business in both the US and the UK (Oxford Diagnostic Laboratories) designed to provide unparalleled levels of expertise, service, turnaround time and simplicity for physicians wanting to access immunological tests such as the T-SPOT.TB test.

T-SPOT and the Oxford Immunotec logo are registered trademarks of Oxford Immunotec Ltd. CPT is a registered trademark of the American Medical Association

References

1. WHO. Diagnostics for tuberculosis : global demand and market potential. 2006


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