CAJICA, Colombia – Chembio Diagnostic Systems Inc., a point-of-care diagnostic company focused on infectious diseases, received the approval from Anvisa, the Brazilian health care surveillance agency, to distribute its tests in the Latin American market.

The approval adds yet another test to the hundreds already approved in Brazil, where the market for such tests is quickly getting crowded sending prices down. Brazil is one of the countries most affected by COVID-19 with almost 6 million cases and 166,000 deaths, the third highest number of cases in the world.

“Combined with Anvisa’s prior approval for emergency use of the DPP COVID-19 IgM/IgG assay, we are now able to offer the Brazilian health care system tests that detect active infections and provide antibody status that both run on the same Micro Reader analyzers,” said Charles Caso, vice president of sales and marketing at Chembio

“We view Brazil as one of the most attractive infectious disease testing markets in the world, and we plan to expand the commercial team at Chembio Diagnostics Brazil to leverage our growing portfolio of approved tests in the country,” Caso said. One of the main markets in Brazil for Chembio, based out of Hauppauge, N.Y., is HIV testing, but the surge in COVID-19 cases has opened up this new market opportunity.

“We believe helping people understand their infection status has shown to be one of the most effective methods for controlling the spread of COVID-19,” said Javan Esfandiari, vice president and chief science and technology officer at Chembio. “Enabling patients and providers to know this information at the point-of-care in 20 minutes can help further reduce the risk of virus transmission and improve patient outcomes.”

Anvisa, the Brazilain regulatory agency, has approved 448 tests, out of the 710 that have requested marketing approval. Chembio’s test is on the approved-tests list.

“Anvisa was very fast and proactive changing the legislation and applying a fast track, so they changed the markets, because at the beginning of the pandemic, people were selling IVD tests for COVID-19 at a very high cost, between R$200 ($37.50) and R$300 ($56.30),” Marcelo Brisolla, managing director at Brisa Consultores, a med-tech regulatory consultancy in Sao Paulo, told BioWorld.

“Anvisa acted fast and they approved the first submissions in one week at the beginning of the pandemic, and then a lot of companies sent applications and they are taking more time, but they did a fast track for (Good Manufacturing Practice) certifications, through three pathways: (Medical Device Single Audit Program) MDSAP, reports from third party auditors, and the (International Medical Device Regulators Forum) IMDRF, and they accept these reports to grant the GMP certificates,” said Brisolla.

Anvisa said it is still working to ensure the safety and efficacy of the tests it approves. Efficacy is key, while concerns about false negative results have been a topic of discussion since the outbreak began.

“They are approving the registration of the tests very fast, with a rationale showing that the products are safe and efficient,” said Brisolla. “These actions by Anvisa were fundamental so that the market can receive the tests in time and [tackle] the emergency situation.”

And taking that opportunity for a fast registration for its SARS-CoV-2 test, the U.S. company is using its recently acquired subsidiary in Brazil to tap into the market.

In November 2019, Chembio acquired Orangelife Comercio e Industria Ltda., and transformed it into Chembio Diagnostics Brazil.

“Over the last 15 years, Chembio has supplied millions of infectious disease tests to Brazil’s Ministry of Health through our partner Bio-Manguinhos, an arm of Brazil’s government,” said John Sperzel, the CEO of Chembio at the time of the acquisition. “The acquisition of Orangelife will allow Chembio to expand its commercial presence by offering its high-quality products to the state, private, and pharmacy markets in Brazil.”

The company acquired Orangelfe for $150,000 in cash and 153,707 shares of common stock, with the possibility of paying another 497,288 shares of common stock, subject to certain consulting agreements to be done between 2020 and 2022.

The current CEO of Chembio is Richard Eberly, who was appointed on March 16, 2020.

Anvisa’s decision to fast-track approvals for COVID-19 tests has heated the Brazilian market for those diagnostic tests. According to Brisolla, tests are being acquired through public tender now at a fraction of the price they fetched during the first half of the year. Tests are selling for as little as $2 to $4 through tenders, which Brisolla described as “amazing.”

According to Chembio, its tests are designed to detect SARS-CoV-2 antigens in only 20 minutes.

“The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader 1 or DPP Micro Reader 2 analyzer, and a minimally invasive nasal swab,” the company said. “Clinical trial data demonstrates sensitivity of 96.0% at zero to six days from the onset of symptoms and specificity of 98.7% on symptomatic population as compared to PCR tests.”