TAG, TB CAB open letter to Alere

Re: Responsible marketing and access plans for Alere’s Determine TB-­LAM antigen test for active TB

You can download from here an open letter urging Alere to develop responsible marketing and access plans for its Determine TB-­LAM antigen test.

The letter requests that Alere:

1) register the test, make it affordable and accessible, and responsibly market the test in areas in Eastern Europe and Central Asia with high rates of HIV and TB co-infection, and

2) ensure that the Determine TB-­LAM antigen test is not used inappropriately in India and elsewhere.

Alere's marketing and access plans must be mindful of different settings’ unique disease burdens, and shared with advocacy organizations, request the letter's signatories, who include Treatment Action Group (TAG), the Global TB Community Advisory Board (TB CAB), Eastern Europe and Central Asia Community Advisory Board (EECA CAB), India Community Advisory Board (India CAB), International Treatment Preparedness Coalition, Russia (ITPCru), Kaliningrad Regional Non-Profit Organization “Status-Plus”, National Coalition of PLHIV in India (NCPI+) and the Non-Profit Partnership to Increase the Quality of Life for Women Living with and Affected by HIV-Infection and Other Socially Significant Diseases (EVT).

Determine TB-­LAM antigen test is a simple, non-­invasive and rapid tool, indicated for detection of active TB in people living with HIV with very low CD4 counts, a very important population to diagnose and treat in many parts of the world. The test detects TB best in HIV-positive people with CD4 counts less than 100 cells/mm3, and who have TB symptoms. Without this test, it is extremely difficult to diagnose TB in people with HIV with low CD4 counts. "We appreciate the important role that this test can play in allowing people with TB and HIV to be diagnosed and linked to care."

However, the authors express concern that the test may be used in populations for which it is not intended, and urge Alere to prevent misuse of the test through responsible marketing. "In all settings, we urge you to market your test only as indicated according to data from clinical trials, and take action to stop any unethical, off-­label use of the test."

The letter is the third of a series of letters urging companies to take action to stop the unethical, off-label use of the TB tests (read an open letter to Qiagen about QuantiFERON-TB Gold here and an open letter to Immunoshop about TB Platinum here).

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By Treatment Action Group, TB CAB

Published: Aug. 7, 2013, 8:03 p.m.

Last updated: Aug. 8, 2013, 12:09 a.m.

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