GeneXpert MTB/RIF: new developments on uptake and pricing

Theo Smart
Published: 19 June 2012

The advocacy pre-meeting at the South African TB Conference started with a presentation on GeneXpert and the need for affordable TB diagnostics by Colleen Daniels, formerly with WHO’s STOP TB Department, but now the Senior Policy Associate for TB with the Treatment Action Group (TAG), a rather remarkable coup for the organisation. She provided some interesting data on the early uptake of the Xpert MTB/Rif test for TB, which was covered in a recent series of HATIP editions.

During her presentation, she stated that by 27 March 2012, 611 GeneXpert instruments and 863,790 cartridges (Xpert tests) had been procured in 61 resource-constrained countries — but about half of these had been used by the 25 GeneXpert sites operating in South Africa.  Technically, South Africa procured 478,980 cartridges but had only processed 311,117 specimens by about the end of March. Kenya bought 34,310 cartridges.

Cepheid has almost certainly sold well over a million cartridges by now, and had already agreed drop the price to $14 once it had sold so many cartridges, at least by the time it reached the 1.7 million mark, expected to be reached later this year.

However, Colleen Daniels told the audience that this was likely to change this very week, as the board of UNITAID, the global health purchasing facility, was meeting and considering a proposal to ‘buy-down’ the price in association with the Bill and Melinda Gates Foundation, PEPFAR and USAID. (And indeed, late the very next day, UNITAID issued a press release reporting that the partnership of donors was giving Cepheid $30 million to advance its scheduled price reductions ahead by two years, down to $10 per test).

The price reduction will apply to more than 145 purchasers in low and middle income countries, including those with high-burden of multi-drug resistant tuberculosis and co-infection of HIV and tuberculosis.

This should save South Africa a princely sum, though of course the cost of the equipment is still pretty high. As of the end of March, Daniels said that the National Health Laboratory Services placed 30 instruments in 25 microscopy centres.

That figure must refer to machines that have been installed and brought online, because according to some discussions in the corridors, there are GeneXpert machines that have been sitting idle and gathering dust for several months, at more than one South African site — without reagents or anyone trained to use them. HATIP has been able to confirm at least one of these cases. This isn’t necessarily as bad as it sounds — donors have bought some of the GeneXpert machines for the facilities, and one accepts such gifts when they arrive. The roll-out of Xpert in South Africa is doubtless pretty tightly scripted — sites must undergo an assessment to make sure that everything is up to spec. Still, when HATIP heard about this, we though about all those missed or delayed diagnoses and considered volunteering to run the machine ourselves. After all, the Minister said it was easy...

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