NEW YORK, April 27, 2016 /PRNewswire/ -- Emergency approvals of PCR and immunoassay-based Zika tests and the allocation of federal funds for more testing suggest more products are forthcoming, according to Kalorama Information. The IVD-focused market research firm noted the recent Emergency Use Authorization for Roche's LightMix Zika test and approval of a Puerto Rico blood center trial for another molecular test. Kalorama expects more assays to be released in the U.S. market, though demand is likely to be limited outside of select applications. Kalorama Information has been reporting on infectious disease diagnostics for more than a decade, and offers a comprehensive market research report for infectious disease testing: The World Market for Infectious Disease Diagnostic Tests.
Kalorama views recent developments as reflective of the US government's commitment to being ready for any potential threat, but not indicative of a large IVD market near-term.
"In terms of impact on the IVD market, Kalorama Information sees Zika as limited in its current form," said Emil Salazar, analyst for Kalorama Information in a recent blog post. "Primary points of testing demand could emerge with the inclusion of the Zika virus in blood screening at U.S. blood centers. Fetal developmental issues associated with the Zika virus could also result in the implementation of standard screening among pregnant women and infants – similar to ToRCH panel screening - in the southern regional United States."
Mosquito-borne transmission of the Zika virus in the continental United States is likely to first occur this year through the disease's principal vector, A. aegypti mosquitoes, present in up to 25 U.S. states. Clinical preparedness for the disease will necessarily entail commercially available tests, which are now likely to receive expedited review by the FDA.
"The scale of future mosquito-borne Zika virus infections in the United States is difficult to project, though several experts believe its incidence will be marginal in the continental United States – on a scale similar to A. aegypti-spread dengue and chikungunya – and likely limited to the most conducive environment of the southern United States (Gulf Coast states such as Texas, Louisiana, Mississippi, Alabama and Florida)," Salazar said.
Roche announced recently that the FDA has provided Emergency Use Authorization for its LightMix Zika Virus real-time RT-PCR test kit for use with CDC-approved Roche viral nucleic acid extraction reagents and LightCycler instruments. Roche has also been able in early 2016 to deploy its cobas Zika nucleic acid test (NAT) among Puerto Rican blood centers under FDA Investigational New Drug (IND) designation. The IND designation for the cobas Zika test allows for cost recovery, but bars Roche from profitable sales from its trial in Puerto Rico. Industry-led national preparedness against the Zika virus will also be supported by nearly $600 million in federal funds originally provided for the control of Ebola in West Africa. The Obama administration has still requested $1.9 billion in new funds for the Zika virus. Federal funds are expected to be used for the development of vaccines and additional Zika diagnostics.
The U.S. Centers for Disease Control and Prevention (CDC) has issued emergency use authorizations (EUA) for a Zika IgM Antibody Capture ELISA (MAC-ELISA) kit and real-time reverse transcriptase PCR (RT-PCR) kit. Controls and kit reagents are available through the CDC, but their distribution is limited to qualified, PHEP-funded state and local public health laboratories.
Ultimately, developments in Zika virus testing in the United States will follow the progress of the disease in the world's largest healthcare market. All Zika virus infection cases to date in the United States have been travel-associated, directly transmitted from an infected individual, or occurred in the U.S. territories of the Virgin Islands, Puerto Rico, and American Samoa. The preeminent public health threat posed by Zika virus infection is microcephaly and other fetal brain defects when pregnant women are infected. Infections may also result in a relatively limited number of cases of Guillan-Barré Syndrome, a form of autoimmune neuropathy.
Kalorama Information's reportThe World Market for Infectious Disease Diagnostic Tests contains detailed market sizing and forecasts for key areas of diagnostic testing, including ID/AST, immunoassays, molecular testing and blood banking tests. Major trends are discussed and competitors in the industry are profiled. The report is available at http://www.kaloramainformation.com/redirect.asp?progid=88636&productid=9367616.
About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. Reports can be purchased through Kalorama's and are also available on www.marketresearch.com and www.profound.com.
We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog at www.kaloramainformation.com.
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SOURCE Kalorama Information