Cellestis Launches TB Operation Support Solution to Support U.S. Public Health Officials with TB Contact Investigations

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Cellestis has launched the TB Operation Support Solution (TBoss), a comprehensive service to help support U.S. public health officials in the management of TB contact investigations through the use of QuantiFERON®-TB Gold (QFT®), an interferon gamma release assay (IGRA) approved by the FDA as an in vitro diagnostic aid for the detection of TB infection.

Tuberculosis (TB) is a highly contagious and potentially fatal disease affecting more than 2 billion people worldwide. (1) In the United States (U.S.), more than 11,000 cases of TB were reported in 2010. (2) Diminishing the incidence of TB requires the quick and accurate identification of those who may have been in contact with someone with active TB. (3) However, TB Contact Investigations require a substantial amount of work and resources: 79 percent of TB cases in the U.S. are pulmonary,(4) requiring contact investigations which involve, on average, 10 contacts per case. (5) Recent cuts to the overall budget for the TB Division of the Centers for Disease Control and Prevention, as well as to the budget for the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention6 are going to make tackling TB in the U.S. even more challenging for U.S. Public Health officials. Industry-provided support solutions, such as Cellestis Inc.’s TB Operation Support Solution (TBoss) service, will provide U.S. Public Health with an additional resource to help facilitate successful outcomes of resource-intensive activities like Contact Investigations.

Cellestis has launched the TB Operation Support Solution (TBoss), a comprehensive service to help support U.S. public health officials in the management of TB contact investigations through the use of QuantiFERON®-TB Gold (QFT®), an interferon gamma release assay (IGRA) approved by the FDA as an in vitro diagnostic aid for the detection of TB infection. Contact Investigations entail several complex and highly time-sensitive actions, including the mobilization of public health staff, the identification of potential contacts, the organization and implementation of TB testing, and the analysis of test results (6) TBoss was designed to help alleviate some of the challenges Public Health officials face during contact investigations, including the identification and mobilization of the resources required to evaluate and diagnose potential TB contacts quickly and effectively. Cellestis is familiar with the difficulties around Contact Investigations; throughout the last year, several U.S. public health departments have requested Cellestis’ assistance with investigations ranging from contact investigations in Kansas and in Alameda County (California). (5) By successfully helping to manage various investigations, Cellestis has demonstrated its ability and commitment to being an effective partner for public health departments.

“QFT is really a game-changer in contact investigations, both in terms of cost-effectiveness and patient compliance,” said Lee Reichman, MD, MPH, FACP, FCCP, Professor of Medicine, Preventive Medicine & Community Health New Jersey Medical School, Executive Director, New Jersey Medical School Global Tuberculosis Institute at UMDNJ. “QFT is more efficient and more specific than the Tuberculin Skin Test (TST), resulting in fewer false positives and more credible test results.”

QFT offers a modern, cost-effective alternative to the TST, previously the only available method for diagnostic testing of TB contacts. QFT is 99.2% specific for Mycobacterium tuberculosis, (7) the bacterium which causes TB infection, and is not affected by the Bacille Calmet-Guérin vaccine. (8) QFT also requires only one clinic visit for blood collection, with no follow-up visit required. (6) In addition, QFT has demonstrated a lower rate of false positives than TST and a negative predictive value of 100% to date (9,10,11) thus increasing cost-effectiveness by reducing unnecessary work-up, prophylactic treatment and medical follow-up. (5)

Through TBoss, Cellestis provides public health departments with a dedicated TBoss Program Coordinator who assists the public health official leading the Contact Investigation in identifying necessary resources. (6) TBoss further supports public health departments by deploying phlebotomy resources to assist with the collection of blood and by identifying QFT-enabled laboratories to collect the samples, carry out testing and deliver results directly to the public health department. (6)

Public health departments interested in the TBoss service can contact Cellestis at 1-855-QFT-TBOS(S) or tboss(at)cellestis(dot)com. For additional information about TBoss, QFT and TB, please visit http://www.TBossNews.com.

About QuantiFERON-TB Gold (QFT)
QuantiFERON-TB Gold (QFT) is a simple blood test that accurately identifies people infected with Mycobacterium tuberculosis, the causative agent of Tuberculosis (TB). As a modern alternative to the 110 year old Tuberculin Skin Test (TST), also known as the Mantoux, QFT offers unmatched specificity, high sensitivity and simplicity. QFT enables focused TB therapy by providing clinicians with an accurate, reliable and convenient TB diagnostic tool. QFT is unaffected by previous BCG vaccination and most other environmental mycobacteria. Unlike the TST, it requires only one patient visit, is a controlled laboratory test and provides an objective, reproducible result that is unaffected by subjective interpretation. Results can be available within 24 hours.

QFT is available for use in all clinical settings in which TST is commonly used. Examples include contact tracing, regular employee testing, for example for health care workers, as well as screening programs for prisoners and immigrants. QFT’s application offers distinct advantages over the TST in the screening of immunosuppressed patients prior to anti-TNF-alpha therapy initiation and in patients with HIV, cancer or organ transplants.

QFT is sold directly in the U.S. by Cellestis Inc; in Europe by Cellestis GmbH (Germany); and in Australia and Asia by Cellestis International Pty. Ltd. (Australia). QFT is also available through Cellestis Commercial Partners in Japan, Europe, the Middle East and other countries around the world.

(1) Stop TB Partnership. Tuberculosis Vaccines – Hope for the Future. World Health Organization, 2008. Available at: http://www.stoptb.org/wg/new_vaccines/assets/documents/TB%20Vaccine%20brochure%20latest.pdf.

(2) Centers for Disease Control and Prevention. Tuberculosis Data and Statistics. Centers for Disease Control and Prevention, 2011. Available at: http://www.cdc.gov/tb/statistics/default.htm.

(3) Centers for Disease Control and Prevention. Guidelines for the Investigation of Contacts of Persons with Infectious Tuberculosis: Recommendations from the National Tuberculosis Controllers Association and CDC. Morbidity and Mortality Weekly Report 54:RR-15 (2005). Available at: http://www.cdc.gov/mmwr/pdf/rr/rr5415.pdf.

(4) National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. Reported Tuberculosis in the United States, 2009. Centers for Disease Control and Prevention, 2010. Available at: http://www.cdc.gov/tb/statistics/reports/2009/pdf/report2009.pdf.

(5) Data on file. Cellestis (“QFT News, Issue 1, 2011”), 2011.

(6) Data on file. Cellestis (“Sales Brochure: TBoss – Your support in the fight against TB”), 2011.

(7) Diel et al. “Evidence-based comparison of commercial interferon-gamma release assays for detective active TB: a metaanalysis.” Chest (2010) 137: 952 – 968.

(8) Mori T, Sakatani M, Yamagishi F, et al. „Specific detection of tuberculosis infection: an interferon-gamma-based assay using new antigens.” Am J Respir Crit Care Med (2004) 170: 59 – 64.

(9) Diel R, Loddenkemper R, Niemann S, Meywald-Walter K, Nienhaus A. “Negative and positive predictive value of a whole-blood IGRA for developing active TB – an update.” Am J Respir Crit Care Med (2008).

(10) Diel R, Loddenkemper R, Meywald-Walter K, Niemann S, Nienhaus A. “Predictive value of a whole-blood IFN-γ assay for the development of active tuberculosis disease after recent infection with Mycobacterium tuberculosis.” Am J Respir Crit Care Med (2008) 177: 1164 – 70.

(11) Higuchi K, Harada N, Mori T, Sekiya Y. “Use of QuantiFERON®-TB Gold to investigate tuberculosis contacts in a high school.“ Respirology (2007) 12: 88 – 92.


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