“As countries are struggling to deal with suspected COVID-19 cases, having an accurate rapid diagnostic test is essential for real-time management of people affected with the virus, in order to tackle this pandemic,” said Dr Greg Elder, Medical Coordinator for MSF's Access Campaign. “So many lives could be saved if corporations like Cepheid made their test available urgently and affordably in all countries.”
In March 2020, Cepheid received emergency authorisation from the US Food and Drug Administration for its COVID-19 test to detect coronavirus at the near point-of-care, delivering results in less than an hour. The test is designed for use on Cepheid’s GeneXpert testing platforms, which are already being used across the world for diagnosis of TB and other infectious diseases. There are an estimated 11,000 GeneXpert instruments in low- and middle-income countries.
Cepheid has set the price for each test at $19.80 in 145 developing countries, including the world’s poorest countries where people live on less than two dollars per day. However, Cepheid developed the Xpert Xpress SARS-CoV-2 cartridge with $3.7 million in public funding from the US government’s Biomedical Advanced Research and Development Authority (BARDA).
Additionally, MSF and others’ analysis of the cost of manufacturing Cepheid’s tuberculosis (TB) test – which is similar to the COVID-19 cartridge – shows that the cost of goods, including materials, manufacturing, overhead, and other indirect expenses for each cartridge is as low as $3 at high volumes and with relevant royalties expired, and therefore each test could be sold at a profit for $5. The analysis also demonstrates that there was no significant difference between viral and bacterial cartridges that would justify substantial price variances across cartridges for different diseases. MSF called on Cepheid for a significant price reduction of their cartridges to no more than $5, including the COVID-19 test.
“It is indefensible for Cepheid to profit in this pandemic,” said Sharonann Lynch, Senior HIV & TB Advisor for MSF’s Access Campaign. “This is not the time to set the price based on profit margins. This critical test must be made accessible to all people who urgently need it at $5 per test to tackle this global health emergency.”
Commitments to equitable access
The World Health Organization (WHO) along with several of its partners set up the ‘Diagnostics Consortium’ in March 2020 to support rapid and equitable access to COVID-19 health products and diagnostics for low- and middle-income countries. The Consortium secured volume commitments from major diagnostic test manufacturers (Abbott, Cepheid, Roche, and Thermo Fisher) for a period of four months. According to the Consortium, the amounts committed from Cepheid represented only one-third of its COVID-19 cartridge manufacturing capacity. As a result, less than half of countries’ orders into the Consortium have been fulfilled. The Consortium and corporations, including Cepheid, are set to meet again to negotiate supply volumes and prices for the next four-month period (September-December).
“In this raging pandemic, wealthier countries have a tremendous advantage over others in buying COVID-19 medical tools for their use first,” said Lynch. “We are deeply concerned that people in many resource-limited countries will be deprived of this critical diagnostic test. We need to see Cepheid take the right steps and guarantee a fair allocation and affordable supply of its COVID-19 test to the Diagnostic Consortium to help countries that would otherwise be left behind or left out of bilateral deals. No one should be denied access based on where they come from or what they earn.”