The Stop TB Partnership’s Global Drug Facility (GDF) announced last week that there could be significant supply delays of the critical GeneXpert TB tests, due to production constraints by Cepheid, the US-based corporation that produces the test.
The delays are caused by Covid supply chain challenges and an increasing demand for GeneXpert TB tests.
Doctors Without Borders says that further delays in supplying this critical tuberculosis (TB) test will only cost more lives, at a time when national programs are seeking to scale up TB testing to at least pre-Covid levels.
Cepheid must stop backsliding and prioritising profits over people’s lives and take urgent measures to ensure this TB test is available and affordable in all countries with a high TB burden, says Doctors Without Borders.
Countries placing larger orders may face delays of up to 6 months.
The backlog of orders for TB tests is expected to last through March 2023.
Until additional suppliers enter the market, many TB testing services in low- and middle-income countries still rely exclusively on the GeneXpert TB tests supplied by Cepheid, says Doctors Without Borders.
During the Covid-19 pandemic, Cepheid saw 100% core revenue growth surpassing $2 billion in annual revenue in 2020.
Cepheid’s annual revenue increased in 2021 to $2.88 billion due to high demand for its combination; test to detect Sars-CoV-2, influenza A and B, and respiratory syncytial virus, which is almost exclusively used in high-income countries.
This four-in-one respiratory test made up half of the 16 million Covid tests that were shipped in the second quarter of 2022, with Covid-only tests comprising the remainder.
“It is unacceptable that the US corporation Cepheid seems to prioritise selling Covid tests to wealthy countries over supplying high TB burden countries with TB tests. Delays in supply of TB tests are devastating to national TB programs in countries where the Covid pandemic has alarmingly reversed years of progress made in the fight against TB. Now more than ever, we need to see a doubling down on urgent actions to help countries to scale up TB testing services,” says Stijn Deborggraeve, MSF Access Campaign Diagnostics Advisor.
In addition to supply challenges, the persistently high price of GeneXpert tests has been a barrier to scaling up TB testing services in many countries, says the organisation.
Despite Cepheid having seen an increase in its TB test sales volume year after year and a doubling of its annual revenue during the Covid pandemic, reaching over $2 billion, the corporation has kept the price of the TB tests locked in at $9.98 for more than a decade. It is estimated to cost Cepheid less than $5 to produce the test, but our repeated calls on Cepheid to reduce the price of the test to $5 have been consistently ignored,
Further delays in supplying this critical TB test will only cost more lives. At a time when national programs are seeking to scale up TB testing to at least pre-Covid levels, Cepheid must stop backsliding and prioritising profits over people’s lives and take urgent measures to ensure this TB test is available and affordable in all countries with a high TB burden, says MSF.
“As a humanitarian medical organisation providing TB care in over 35 low- and middle-income countries, we have seen how many people are left undiagnosed for TB because of the Covid pandemic. A shortage of TB tests at this critical juncture will be disastrous.”