By GREGORY ZELLER //
Add another critical Brazilian regulatory approval to Chembio Diagnostics’ portfolio.
The Medford-based point-of-care diagnostics specialist announced this its week the Agência Nacional de Vigilância Sanitária, Brazil’s federal health-regulatory agency, has approved Chembio’s DPP Dengue System.
The test allows “simultaneous and discrete” detection of antibodies against all four dengue serotypes, covering both active infection by dengue virus and prior exposure to the virus – critical measures for both treatment and surveillance of the infectious disease, according to Chembio.
The test – approved by ANVISA in collaboration with Bio-Manguinhos, a Brazilian government agency and supplier of diagnostic products to Brazil’s Ministry of Health – tests a drop of blood from the fingertip and provides results within 15 minutes through Chembio’s proprietary DPP Micro Reader, the Medford biotech said in a statement.
The regulatory approvals follow an evaluation by Brazil’s Instituto Nacional de Controle de Qualidade em Saúde (the country’s leading healthcare quality-control institute) that demonstrated “outstanding analytical performance” by the DPP Dengue System in detecting and identifying both active infections and prior virus exposure.
With the number of dengue cases in Brazil skyrocketing, the approvals come at a critical moment, according to Chembio CEO John Sperzel III.
“We are pleased to receive ANVISA approval for our dengue test, which shows high sensitivity and specificity, especially considering that the number of dengue cases in Brazil tripled compared to last year,” the chief executive said Tuesday.
The DPP Dengue System’s green light follows Brazilian approvals for Chembio’s zika virus field kits, approved by ANVISA in 2016, and 2017 regulatory nods for the company’s combination HIV/syphilis assay throughout Europe and the Caribbean.
“We now have multiple point-of-care tests available in Brazil and look forward to fulfilling the recently-announced initial order from Bio-Manguinhos for our dengue, chikungunya and Zika tests,” Sperzel added.
While the other approved assays have helped the biotech’s bottom line – company revenues increased 8 percent, year-over-year, for the three months ended March 31 – the new dengue approval may prove to be Chembio’s strongest vertical yet, based on the rapid spread of the dengue virus.
According to the World Health Organization, there are nearly 400 million annual dengue infections globally – and another 3.9 billion people, in 128 countries, are at risk of infection.
In Brazil, meanwhile, the Pan American Health Organization has already tallied nearly 600,000 cases of dengue during 2019, including nearly 400 cases of “severe dengue” and 169 dengue-related deaths.