Early Implications of the Zika Virus for the U.S. Diagnostics Market

Early Implications of the Zika Virus for the U.S. Diagnostics Market

In addition to its blog posts regarding infectious disease threats, Kalorama Information offers a comprehensive market research report for global infectious disease testing.

Since the last blog entry regarding Zika virus 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. 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 coming year is likely to see the implementation of testing protocols for the Zika virus and release of additional assays in the U.S. market.

Mosquito-borne transmission of the Zika virus in the continental United States is likely to first occur this year with the disease’s spread in the Americas and presence of its principal vector, A. aegypti mosquitoes, in up to 25 U.S. states.

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 or autoimmune neuropathy.

Senators Bill Nelson and Macro Rubio of Florida, representing a state expected to emerge as a frontline for Zika virus infections in the United States, are among many politicians that have pressed for the emerging disease threat’s prioritization in federal funding and regulatory review. Bipartisan support has already passed S.B. 2512 through both houses of Congress and is awaiting the President’s signature. The bill would add the Zika virus to the FDA’s Priority Review Voucher Program that requires FDA response to applicant drugs, vaccines and diagnostics within 6 months.

While Rubio and other legislators have assailed a backlog of Zika virus diagnostics, the FDA has already moved to complement CDC-provided Zika virus tests with industry-available EUA kits. 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 cobas test will be assessed for its ability to screen blood donations for Zika virus infection.

While Rubio and other legislators have assailed a backlog of Zika virus diagnostics, the FDA has already moved to complement CDC-provided Zika virus tests with industry-available EUA kits.

The IND designation for the cobas Zika test allows for cost recovery, but bars Roche from profitable sales from its trial in Puerto Rico. IND designation alleviates cost disincentives for the development of new drugs, diagnostics and other biologics, especially in the case of newly emergent diseases. 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.

Other companies that may potentially serve the clinical market for Zika testing with EUA-granted tests include GenArraytion, Vela Diagnostics, Genekam Biotech, and First Diagnostic Ltd. The tests offered by the first three companies were profiled in a previous blog post.

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). Potential exists for the Zika virus to spread beyond most U.S. projections as some 200 million live in the observed range of the A. aegypti mosquito. Any broad-based screening effort for Zika virus infections is likely to focus on pregnant women and women planning pregnancies. Monitoring of fetal brain abnormalities or microcephaly in positive cases has been accomplished with ultrasound and MRI scans.

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 … southern United States

Uncertainty regarding the future reach of the Zika virus into the United States leaves a range of potential market outcomes for associated IVD tests. As of April 13, 2016, a total over 800 Zika virus cases have been reported in the United States and its territories, including 471 locally acquired cases (the vast majority in Puerto Rico). CDC Director Dr. Tom Frieden has cautioned that the Zika virus is likely to spread rapidly in Puerto Rico citing the past rapid spread of Chikungunya virus on the island. Over the summer of 2014, chikungunya went from its first case in Puerto Rico to over 10,000 cases and ultimately infected more than a quarter of the adult population. Locally acquired chikungunya in the United States has been relatively negligible stateside with only 12 cases in Florida reported in 2014.

The Zika virus’s epidemiology in the United States will likely depend on the virus rather than the vector; diseases such as chikungunya, West Nile and dengue fever share a common vector in A. aegypti and even a secondary more prevalent U.S. vector in A. albopictus, but have not spread significantly in the United States.

In recent years, cases of other arboviral diseases (arthropod vector-borne) in the United States such as the mosquito-transmitted West Nile virus and dengue fever have been reported over 2,000 and under 1,000 cases respectively annually in the United States. The Zika virus’s epidemiology in the United States will likely depend on the virus rather than the vector; diseases such as chikungunya, West Nile and dengue fever share a common vector in A. aegypti and even a secondary more prevalent U.S. vector in A. albopictus, but have not spread significantly in the United States.

Perhaps more impactful to testing demand would be the inclusion of the Zika virus in standard 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.

Although the number of stateside Zika virus infections may remain relatively low, the possibility of epidemic remains in Puerto Rico and other territories. Perhaps more impactful to testing demand would be the inclusion of the Zika virus in standard 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.