MSF: Cepheid’s production delays of critical tuberculosis test will cost lives

Ebola response in Mangina

Democratic Republic of Congo 2018 © Carl Theunis/MSF

NEW YORK/GENEVA, SEPTEMBER 15, 2022—There could be significant supply delays of the critical GeneXpert tuberculosis (TB) test due to production constraints by Cepheid, the US-based corporation that produces the test. The delays are caused by COVID-19 supply chain challenges and an increasing demand for GeneXpert TB tests. At the same time, Cepheid seems to be prioritizing their production of more profitable COVID-19 tests to wealthy countries over TB tests for lower-income, high-burden TB countries, said Doctors Without Borders/Médecins Sans Frontières (MSF).

During the COVID-19 pandemic, Cepheid saw 100 percent core revenue growth and passed $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-19 tests that were shipped in the second quarter of 2022, with COVID-19-only tests comprising the remainder.

The GeneXpert test is the only testing option of its kind in most low- and middle-income countries, including those with high TB burdens. The backlog of orders for TB tests is expected to last through March 2023. This test is critical for diagnosing people with TB and getting them on treatment quickly as it gives results within a few hours instead of days or weeks like traditional tests. It can also help curb further spread of TB, which is one of the leading infectious disease killers worldwide.

In addition to supply challenges, the persistent high price of GeneXpert tests has 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, the company has been charging high-burden countries double that price per TB test for more than ten years.

Stijn Deborggraeve, diagnostics advisor for MSF’s Access Campaign, said of the expected delay:

“It is unacceptable that the US corporation Cepheid seems to prioritize selling COVID-19 tests to wealthy countries over supplying high-burden countries with TB tests. Delays in supply of TB tests are devastating to national TB programs in countries where the COVID-19 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-19 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 organization 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-19 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-19 levels, Cepheid must stop backsliding and prioritizing profits over people’s lives and take urgent measures to ensure this TB test is available and affordable in all countries with a high burden.”