John Sperzel III

Chembio’s dengue field test earns Brazilian nod

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…


Down, but hardly out, at comeback-primed Chembio

By GREGORY ZELLER // Operating and net losses that more than tripled year-over-year tell only part of the story of Chembio Diagnostic Systems Inc.’s first quarter. That was the message Tuesday from John Sperzel III, chief executive of the point-of-care diagnostics specialist, who addressed investors in a conference call after the firm shared the results of the first quarter of its fiscal 2017, which ended March 31. It was another down quarter for the Medford-based…


Can Chembio rebound? You bet your assays

By GREGORY ZELLER // Chembio Diagnostics Systems Inc. has significantly diversified its product portfolio, built up its global sales infrastructure and expanded its operational capacities – but the numbers just aren’t there for the Medford-based biotech. Reporting Tuesday on the results of its 2016 fourth quarter and its 2016 fiscal year, which both ended Dec. 31., the manufacturer of point-of-care diagnostic tests for infectious diseases (Nasdaq: CEMI) noted a series of down numbers, with declining…


At Chembio, looking beyond the numbers

By GREGORY ZELLER // While it made “important advances … intended to prepare the company for growth,” according to its CEO, Chembio Diagnostic Systems has suffered another subpar fiscal quarter. The news is not all bad for the Medford-based biotech, which produces point-of-care diagnostic tests for a range of medical conditions. Earlier this month, the company announced the acquisition of a private Malaysian distributor of POC diagnostic tests, while Brazil’s national health-regulatory agency has approved…


In Brazil, a big forward step for Chembio

The national health-regulatory agency of Brazil has approved commercial use of Chembio Diagnostics’ rapid field rest for the Zika virus – a major step toward selling the product in the Zika-ravaged Brazilian market. Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) has greenlighted the DPP Zika IgM/IgG Assay, which detects antibodies using a tiny drop of blood and provides “semi-quantitative results” in 15 minutes, according to the company, using Chembio Diagnostics’ patented virus-detection platform and a…


Sales drop, tax bite sting Chembio Diagnostics

Medford biotech Chembio Diagnostic Systems Inc. took it on the chin in the second quarter, with steep losses attributed to declining sales for its infectious-disease detectors and a one-time, multimillion-dollar tax provision. According to quarterly financials released Thursday, the company – dba Chembio Diagnostics – reported total revenues of $3.27 million in the quarter ended June 30, a 51 percent drop from the $6.72 million reported for 2Q 2015. Quarterly product sales plunged nearly 68…