InBios Receives FDA Market Authorization for its ZIKV Detect 2.0 IgM Capture ELISA for a Presumptive Diagnosis of Zika Virus Infection

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InBios announces the FDA permitted marketing of its ZIKV Detect 2.0 IgM Capture ELISA – The first commercial serology diagnostic kit that was granted market authorization from the FDA.

ZIKV Detect 2.0 IgM Capture ELISA

InBios announced today that it received marketing authorization from the FDA for its ZIKV Detect 2.0 IgM Capture ELISA. The product is intended for the presumptive detection of Zika virus IgM antibodies in human sera collected from individuals who meet the criteria of the Centers for Disease Control and Prevention (CDC) for Zika virus clinical infection, which include a history of associated clinical symptoms or travel from a geographic location with active Zika transmission. This important diagnostic test kit contains all the necessary reagents and controls to perform the assay and obtain results in about four hours. Additional testing is required to confirm positive results from this assay.

The performance of the InBios Zika assay was evaluated by testing 807 unique specimens from 353 subjects at endemic sites and 256 subjects at non-endemic sites. In samples from patients collected 7 days or later after onset of symptoms, the InBios Zika kit correctly identified >90% of patients confirmed positive for Zika IgM and >96% of patients confirmed negative. In addition to identifying Zika-IgM positive patient samples, the assay differentiates Zika IgM from those infected with other flaviviruses (such as dengue or West Nile virus) which cross-react with Zika antibodies.

Dr. Raychaudhuri, CSO of InBios, said, “InBios has developed this important assay with grant funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Department of Health and Human Services. ZIKV Detect represents our most innovative product to date in our portfolio of flavivirus related products. We have several assays coming down the pipeline that will further improve detection of these complex arboviruses.”

About Zika virus:
Zika virus is a disease that is spread to people primarily through the bite of an infected mosquito of the Aedes species (mainly Aedes aegypti). The same mosquito transmits dengue, West Nile, chikungunya, and yellow fever. The most common symptoms of Zika virus infection are fever, rash, joint pain, and conjunctivitis. Other symptoms include muscle pain and headache. These symptoms can last for several days to a week. Most people with Zika virus infection will not develop symptoms.

Complications:
An infected pregnant woman can pass Zika virus to her fetus during pregnancy or at the time of birth. Also, individuals infected with Zika virus can pass it to sex partners. Zika virus infection during pregnancy can cause a serious birth defect called microcephaly and other severe brain defects. In adults and children, there is an increased risk of neurologic complications including Guillain-Barre syndrome (GBS), neuropathy, and myelitis.

Outbreaks:
Zika virus outbreaks may have occurred in many locations previously but have gone unrecognized because the symptoms are similar to other diseases such as dengue and chikungunya viruses. In May 2015, the Pan American Health Organization (PA-HO) issued an alert regarding the first confirmed Zika virus infection in Brazil and on February 1, 2016, the World Health Organization (WHO) declared Zika virus a public health emergency of international concern (PHEIC). To date, a total of 86 countries and territories have reported evidence of mosquito-transmitted Zika infection. Zika virus infection is a notifiable condition in the United States.

For more information on Zika virus, visit the CDC web-site: https://www.cdc.gov/zika/index.html

This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600014C.

About InBios International, Inc. InBios International, Inc. is committed to providing high quality, affordable diagnostics for infectious diseases to the global marketplace. It develops and manufactures a comprehensive range of diagnostic products affecting global public health. Its product portfolio includes FDA-cleared ELISA kits for Zika, dengue, and West Nile and rapid test kits for Chagas and leishmaniasis. InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified. For more information about InBios’ product portfolio, visit our website at http://www.inbios.com.

References:

1.    https://www.who.int/news-room/fact-sheets/detail/zika-virus
2.    https://www.cdc.gov/zika/index.html
3.    https://wwwn.cdc.gov/nndss/conditions/notifiable/2019/

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Wendy Bagnato
InBios International, Inc.
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