COLOMBIA – South Korea’s molecular diagnostics firm Seegene Inc. is expanding operations in the Brazilian market after Anvisa, the country's health care surveillance agency, cleared its multi-assay product through a COVID-19 emergency pathway.

Seegene manufactures Allplex, a SARS-CoV-2/FluA/FluB/RSV test able to screen and differentiate eight targets, including the S gene, RdRP gene and N gene from the SARS-CoV-2 virus. According to the company, its assay accurately detects the novel coronavirus “even with mutated strains, as it targets multiple coronavirus genes.”

“Seegene believes the official introduction of the COVID-19, influenza, common cold combo assay product in Latin America will definitely help drive up the sales revenue in that region,” the company said.

The expansion in Brazil, which has a population of about 210 million, is a key milestone for the company. There is a lot of demand for COVID-19 tests in Brazil, which has the third highest count of COVID-19 cases in the world behind India and the U.S. Brazil, which already started its vaccination campaign against SARS-CoV-2 in mid-January, has almost nine million confirmed cases of COVID-19 and more than 219,000 deaths. Brazil has also seen a rise of a more contagious variant of SARS-CoV-2, known as B.1.1.28.1 or P.1, that was detected in the Amazon region.

Seegene’s tests entered the Brazilian market last year through the Panamerican Health Organization (PAHO), but now the company is setting up its own operations in Brazil with local partners and distributors as it strengthens distribution in neighboring countries.

“We have our subsidiary offices in Brazil and in Mexico and we are closely working with local clients and vendors in countries like Peru, Ecuador, Venezuela and Argentina,” a Seegene spokeswoman told BioWorld. “Seegene is simultaneously working on getting approval from governments around the world. We continue to pursue working with respective countries to try and curb the spread of COVID-19.”

The company did not disclose how many tests it plans to export to Brazil this year but Anvisa, the regulator, said the country acquired 10 million kits in April 2020 and continued importing them at a rate of 500,000 kits per week through the second half of the year.

In December, Anvisa extended the period of time over which Seegene’s tests are valid in the country to 12 months from the date of manufacturing.

Anvisa said it considered the current epidemiological and sanitary conditions as well as the risks and benefits of extending the validity of the tests and was encouraged by a rapid increase in the number of cases of COVID-19.

“The authorization is subject to the performance of periodic (monthly) monitoring analyzes to assess the specificity and sensitivity of all product lots by the National Institute for Quality Control in Health (INCQS),” it added.

“Accurately distinguishing COVID-19 patients from those with seasonal flu virus has become extremely important, especially at a time when the coronavirus gained extra strength, coupled with a more contagious mutant COVID-19 strain,” said Seegene.

Peru and other Latin American neighbors

Even as it expands its operations in Brazil, Seegene is also eyeing neighboring markets to expand into this year. Close to the top of the list for 2021 is Peru, which has the fourth highest count of COVID-19 in Latin America.

“Seegene’s Allplex SARS-CoV-2/FluA/FluB/RSV Assay won the fiercely competitive bidding process in Peru this year, enabling some 24 regions to proceed with the coronavirus / flu coinfection research project,” said the company.

Seegene is partnering with Simed, from Ecuador, to distribute its tests in Peru.

“The COVID-19 pandemic has laid the groundwork for molecular diagnostic testing in the region, and the company will continue to work with countries in Latin America to curb the spread of coronavirus,” the company said.

Seegene received urgent-use clearance by South Korea's authorities in February 2020 for the distribution of its multi-assay product. The company's digitized development system (SG-DDS), which relies on artificial intelligence (AI), has cut down development times significantly, Seegene said.

Seegene´s expansion across the globe, including Latin America, is driving revenue. The company saw a 40-fold surge in revenue in Latin America in 2020 from ₩4 billion (US$3.6 million) in 2019 to ₩161 billion (US$145 million) in 2020, which the company attributes to the growth in demand of its COVID-19 diagnostic tests across the region.

Seegene has also been marketing its Allplex assay in Europe and Asia.