Increased COVID-19 testing triggers demand for kit reagents

The emerging new mutations of COVID-19 is fueling the global drive for mass testing hence increasing demand for reagents for both testing kits and vaccine production especially in low- and middle-income countries.

Many of the government-supported reagent supply schemes and COVID-19 confirmatory testing schedules have been hampered by inadequate supply of the reagents and even the testing kits as governments grapple with the delicate act of balancing between their existing capacities in public health facilities for carrying out the COVID-19 tests and an increasing demand for the services.

There have been efforts to increase partnerships between governments, especially in low and middle income countries, to partner with pharmaceutical industry in boosting the capacity to manufacture and supply reagents and associated test kits such as reverse transcription polymerase chain reaction (RT-PCR) and those used in specimen extraction for end-users especially hospitals, diagnostic labs and home care consumers.

Due to the disruption in the supply of the COVID-19 test kits, some of the countries such as South Africa, have reported a surge in prices of both the test kits including the reagents as pharmaceutical companies and laboratory service providers compete for a share of the country’s rapid test kits market.

Recently, South Africa, where the Omicron variant was first reported, moved to work closely with the pharmaceutical industry in controlling the pricing of the COVID-19 test kits as concerns emerged about the high cost of the kits due to the fast spread and frequency of the new Omicron variant.

South Africa’s State-agency, the Competition Commission, in December 2021 restrained three of the country’s leading private pathology laboratories from increasing prices, especially for kits used in diagnosis of active SARS-CoV-2 infection, and hence make the testing services affordable to as many people as possible. (1)

The Commission said it had investigated complaints from officials of the Department of Health relating to COVID-19 rapid antigen tests and confirmed the pathology firms were contravening the country’s Competition Act by engaging in excessive pricing.

“The three laboratories indicated their willingness to immediately reduce the price of rapid antigen tests to no more than ZAR150 (US$9.8),” the Commission said.

However, the Commission struck a deal with the three firms after they agreed to sign consent agreements, which were later confirmed as orders by the Competition Tribunal that adjudicates on matters referred to it by the Commission.

The three laboratories also agreed to reduce their prices for COVID-19 PCR tests to no more than ZAR500 (US$32.2).

“For as long as they provide COVID-19 rapid antigen tests, they also undertake to disclose the name of the test kit used to all consumers of these tests, so that they can identify the type of antigen test provided,” the Competition Commission said.

Meanwhile, Guangzhou-based Chinese firm Wondfo, is teaming up with Viatris, through its Gauteng-based South Africa subsidiary, Xixia Pharmaceuticals, to increase supply of its low-cost antigen-detecting rapid diagnostic tests in diagnosis of SARS-CoV-2 in low and middle income countries. The initiative is supported by Foundation for Innovative New Diagnostics (FIND) and global health agency, Unitaid. (2)

“This partnership between a high-volume medical supplies manufacturer and a distributor with global reach has the potential to produce 144 million tests per year, at a ceiling price of US$2.50,” said FIND in a statement.

High quality Ag RDTs remain the primary diagnostic test for detection of active SARS-CoV-2 infection in decentralized settings where timely molecular testing is not available according to WHO’s recently published guidance on national SARS-CoV-2 testing strategies.

“Increasing the capacity of local and regional hubs to produce COVID-19 tests will be vital if we are to ensure truly equitable access to this crucial tool,” Vincent Bretin, Director of Results at Unitaid, said.

“Currently the vast majority of rapid tests being used in low- and middle-income countries are manufactured in just two countries in one region, so these agreements are an important step in ensuring that countries are equipped to detect cases of COVID-19, helping contain outbreaks and bringing a swifter end to the pandemic,” he added.

Elsewhere, the production and supply of reagents for rapid testing kits and treatment for COVID-19 and other endemic diseases would receive a major boost with the construction of a new facility in Mauritius by Cape Biologix Technologies, the production subsidiary of Cape Bio Pharms that is focused on developing plant-based SARS-CoV-2 recombinant proteins for diagnostics and research. The Mauritius specialist manufacturing project is receiving more than US$36.9 million from the European Investment Bank. (3)

“This will enable the company to scale up innovative plant-based manufacturing and to commercialize the successful development of plant based recombinant proteins and in particular, antibodies as a spin-off from the University of Cape Town,” EIB said in a previous statement.

“The large-scale current Good  Manufacturing Practices (cGMP) manufacturing facility aims to ensure the supply of crucial reagents for the production of 100 million vaccines a month for distribution across Africa, the Caribbean and Pacific,” EIB added.

REFERENCES;

1. https://www.comptrib.co.za/cases-current

2. https://www.finddx.org/newsroom/pr-15jul21/

3. https://www.eib.org/en/press/all/2020-388-eib-and-find-back-innovative-plant-based-reagent-manufacturing-in-africa-to-fight-covid-19-and-other-endemic-diseases

About the Author:

With great honor and pleasure, PharmaSources.com has now invited Shem Oirere as one of the original writers. He graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.