• by Emil Salazar
  • August 29 2016


Recent FDA and HHS Actions Spur Development of U.S. Zika Test Market

Recent FDA and HHS Actions Spur Development of U.S. Zika Test Market

For further information regarding the U.S. blood screening and global infectious disease diagnostics markets, Kalorama Information offers the recent market research reports United States Market for In Vitro Diagnostic Tests and The World Market for Infectious Disease Diagnostic Tests.

Investigational and emergency authorized Zika virus diagnostics are expected to find rising demand from U.S. customers following the recent expansion of a U.S. Food and Drug Administration (FDA) recommendation, and will be joined in U.S. healthcare surveillance by rapid tests currently in development under U.S. Department of Health and Human Services (HHS) financial assistance. Last week, the FDA recommended screening of all donated blood and blood products nationwide for Zika virus in order to prevent transfusion-transmitted infections (TTIs). Authorities are seeking to contain the mosquito-borne disease implicated in severe birth defects that spread from South America into Central America, the Caribbean including Puerto Rico, and is being transmitted by mosquitoes in South Florida. The recent U.S. market for blood screening diagnostics has remained level or declined year-over-year due to an established pathogen test menu and slightly declining demand in line with donated blood volume. However, substantial spending on the part of U.S. hospital and blood banks to add Zika virus screening could stimulate market growth. Outside of blood safety, highly accessible testing services (i.e. rapid near-patient tests) are necessary in healthcare settings, both in the United States and abroad, to assist in expanded disease surveillance efforts.

The FDA recommends donated blood be screened using an FDA-licensed (approved) Zika NAT or one under an investigational new drug (IND) application. Available assays in the U.S. market include Roche Diagnostics’ cobas Zika test for cobas 6800/8800 core molecular/NAT analyzers (IND in March 2016) and the Hologic/Grifols Procleix Zika NAT for the Procleix Panther system (IND in June 2016). Nucleic acid tests (NATs) account for approximately 80% of the U.S. blood screening market and are standard for high-sensitivity testing of donated blood. The United States requires 100% of all blood donations to be screened for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), hepatitis B virus (HBV), and West Nile Virus (WNV) using NATs. All blood banks in Latin America and some in the United States also screen donated units for Chagas disease using immunoassays.  Roche cobas 6800/800 systems and the Hologic Procleix Panther are leading platforms for for NAT blood screening in the U.S. market.

The FDA recommends establishments that collect donated whole blood and blood components in Florida and Puerto Rico implement blood screening for Zika or pathogen reduction technology immediately; establishments in Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico, New York, South Carolina and Texas should implement the same guidelines within four weeks; and remaining U.S. establishments within 12 weeks.

Routine surveillance for Zika virus in the U.S. healthcare system will require rapid serology tests that are currently unavailable among Zika virus assays authorized for emergency use. Existing Zika assays rely upon laboratory immunoassay techniques (ELISA) and PCR, and are not suitable for rapid performance as part of triage screening or primary care.  If Zika virus infections rise in the United States, testing demand will likely overwhelm reference laboratories unless testing volume is diverted to rapid tests at the point of care and clinical labs. Serology-based tests similar to lateral flow could rule out cases and leave reference labs to confirmatory testing activities.

In order to support U.S. preparedness for Zika infections, the U.S. Department of Health and Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA) has granted rapid test companies Chembio Diagnostics and OraSure Technologies $13.2 million and up to $16 million respectively. Chembio’s award includes an approximate $6 million commitment to fund the development of the DPP Zika IgM/IgG Assay and its reader instrument and over $7 million for the development and clinical trial testing of the company’s DPP Zika/Chikungunya/Dengue assay for the simultaneous detection of three arboviral diseases. The same program is providing an initial $7 million to OraSure for the development of a rapid Zika assay with results in 30 minutes with an additional roughly $9 million for product enhancements, clinical trials, and regulatory process. The assays would provide results in less than 30 minutes from fingerstick blood samples.