The Stop TB Partnership's Global Drug Facility (GDF) communicated today that there could be significant supply delays of the critical GeneXpert TB test due to production constraints by Cepheid, the US based corporation that produces the test. The communication says that the delays are caused by COVID supply chain challenges and an increasing demand for GeneXpert TB tests. 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. GDF facilitates global access to quality-assured TB diagnostics and treatments through a one-stop procurement and supply mechanism for national TB programs.
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. With national programs in high TB burden countries working hard to ramp testing back up to the same or higher levels as before the COVID pandemic, any supply delays of TB tests by Cepheid are unacceptable, especially as the corporation seems to prioritise sales of COVID tests to wealthy countries over supplying TB tests to high TB burden countries.
During the COVID pandemic, Cepheid saw 100% core revenue growth and passed US$2 billion in annual revenue in 2020. Cepheid’s annual revenue further increased in 2021 to $2.88 billion due to high demand for its combination "four-in-one" 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.
In addition to supply challenges, the persistent high price of GeneXpert tests have been a barrier to scaling up TB testing services in many countries. Despite available analysis that it costs Cepheid less than $5 to manufacture one GeneXpert test, Cepheid has been charging high TB burden countries double that price per TB test for more than ten years.
A shortage of TB tests at this critical juncture will be disastrous.Stijn Deborggraeve, Diagnostics Advisor, MSF Access Campaign, responded to the announcement:
“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 the 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. A shortage of TB tests at this critical juncture will be disastrous.
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.
As a medical humanitarian 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. 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.”