New POC Test for Zika Virus Awarded Conditional LTA from UNICEF

When it comes to infectious diseases, timing is everything.

The time to diagnosis, the time to treatment, and the time a patient is on treatment are all important aspects that affect patient outcomes. This is one of the reasons why point-of-care (POC) tests are extremely valuable.

One such POC test, Chembio Diagnostics, Inc.’s DPP Zika System, was recently awarded a conditional Long-Term Arrangement (LTA) for purchasing from the United Nations Children's Fund (UNICEF), once the company satisfies certain conditions.

The Zika virus—known to cause devastating birth defects known collectively as congenital Zika syndrome in fetuses and infants of infected mothers, as well as conditions such as Guillain-Barré syndrome in adults—is just one of a multitude of diseases where time to diagnosis is important. Research has shown that infection with the virus in the first trimester of pregnancy may be the most detrimental, underscoring the need for rapid diagnostics.

To this end, UNICEF sent out a Request for Proposal (RFP) in February 2017 asking for POC Zika diagnostics through 2019, and Chembio responded. According to a press release on the conditional LTA, the DPP Zika System, “includes the DPP Zika IgM/IgG Assay and DPP Micro Reader, [which] provides quantitative results in 15 minutes from only 10μl of fingertip blood.” In addition, Chembio states that the handheld reader is “easy to use, and can reduce the risk of human error during test interpretation.”

Contagion® spoke with Chembio’s CEO John Sperzel on the new test.

Contagion®: Why is this test still important now as media reports on outbreaks of the Zika virus seem to be winding down?

Sperzel: Although media coverage of Zika has declined, the Zika virus remains a significant health threat. This $10 million allocation of funding is a result of the fact that health care professionals believe Zika will be an ongoing health threat.

What is the significance of a partnership with UNICEF? What does this partnership mean for the product’s disbursement?

The UNICEF relationship is important as it represents another validation of Chembio’s patented DPP technology platform and, assuming the Company meets the UNICEF LTA conditions, will provide a rapid Zika diagnostic test to countries in need.

How will the DPP Zika System improve patient outcomes over currently available tests?

Compared to laboratory-based Zika tests, the main advantages of the DPP Zika System are ease of use and time-to-result. The DPP Zika System is performed with a small drop of blood from the fingertip and provides results in 15 minutes.

How soon is the test expected to become available?

Once Chembio meets the conditions of the UNICEF LTA, the DPP Zika System will be immediately available.

UNICEF'S RFP is supported by a $10 million Advance Purchase Commitment from USAID, which aims to reduce demand uncertainty risks for manufacturers who invest in the research and development of new products. UNICEF is collaborating with partners, such as World Health Organization (WHO) and the Pan American Health Organization, to make commercially available POC diagnostics for Zika virus.

Under terms of the LTA, purchases of the DPP Zika System will begin after Chembio has met the following conditions: receipt of WHO Emergency Use Assessment and Listing, completion of clinical and analytical performance evaluation, and a successful quality management system inspection.