Activists call for withdrawal of substandard TB test from India

TB activists urge the Drug Controller General of India to withdraw GeneDrive test for TB from the Indian market.

In an open letter to the Drug Controller General of India, the Global TB Community Advisory Board (TB CAB) urged the Indian regulator to withdraw Epistem’s GeneDrive TB test from the market.

GeneDrive is a rapid sputum-based TB test with demonstrated performance worse than smear. It does not meet the World Health Organization standards for a smear microscopy replacement test.

In the letter, activists request immediate action to rescind the marketing approval granted to Epistem for GeneDrive by the Drug Controller General of India in April 2015 and for the implementation of more stringent requirements and higher standards for future diagnostic tests.

“GeneDrive’s clear inferiority to existing and forthcoming TB tests, its high price, and potential for rampant misuse, especially in the private sector, support our call for immediate revocation of Epistem’s marketing authorization in India. If Epistem is allowed to go forward with its planned commercial launch in India, we have no doubts that GeneDrive will squander resources and do more harm than good for TB patients.”

TB CAB requests a response to the letter before July 20th.

To read the letter, click here.

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Published: July 6, 2016, 9:37 p.m.

Last updated: July 6, 2016, 9:37 p.m.

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