InBios
InBios International, Inc. is a medical diagnostic company based in Seattle[1] that specializes in the design, development, and manufacture of immunodiagnostic devices for infectious diseases. The company was founded in 1996 and, since its inception, has developed several technologies useful in designing rapid and ELISA based immunodiagnostic assays. InBios offers a number of life science reagents, along with a portfolio of more than 25 diagnostic products, including FDA Emergency Use Authorization for COVID-19 products and 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.
In response to the COVID-19 pandemic, InBios developed a suite of diagnostic products in 2020, including a PCR kit [2] and ELISA tests [3][4] that have been granted Emergency Use Authorization by the FDA. In October 2020, the Department of Defense, in coordination with the Department of Health and Human Services, awarded a $12.67 million contract to InBios to expand US based industrial production capacity of two point of care, rapid COVID-19 tests.[5]
In 2016, InBios received an EUA from the FDA for its ZIKV Detect™ IgM Capture ELISA, the first commercial serology diagnostic kit for Zika virus to receive an FDA EUA.[6] In 2019, InBios announced that the FDA permitted marketing of its ZIKV Detect 2.0 IgM Capture ELISA, becoming the first commercial serology diagnostic kit to be granted market authorization from the FDA.[7]
In 2011, InBios International announced the clearance of its IgM test for dengue fever, DENV Detect IgM Capture ELISA. It is the first test for the diagnosis of dengue infection approved in the United States.[8][9] The technology is based on detecting dengue specific IgM antibodies in the serum of afflicted patients. The test is available internationally, especially in Southeast Asia, where dengue fever is particularly prevalent. The company also manufactures tests for other infectious diseases, including Leishmaniasis, Chagas disease, Scrub Typhus, Leptospirosis, Malaria, and West Nile.[10]
External links[edit]
References[edit]
- ↑ "InBios International, Inc". InBios. Retrieved November 14, 2016.
- ↑ "InBios Receives EUA from FDA for its Smart Detect SARS-CoV-2 rRT-PCR Kit." April 8, 2020. https://www.prweb.com/releases/inbios_receives_emergency_use_authorization_for_its_smart_detect_sars_cov_2_rrt_pcr_kit_for_detection_of_the_virus_causing_covid_19/prweb17036897.htm
- ↑ "InBios Receives FDA EUA FOR COVID-19 Antibody Test." June 11, 2020. https://www.prweb.com/releases/inbios_receives_fda_emergency_use_authorization_for_covid_19_antibody_test/prweb17183541.htm
- ↑ "InBios Receives FDA EUA for Second COVID-19 Antibody Test." July 1, 2020. https://www.prweb.com/releases/inbios_receives_fda_emergency_use_authorization_for_second_covid_19_antibody_test/prweb17230805.htm
- ↑ "DoD Awards $12.67M Contract to InBios. Oct. 30, 2020. "https://www.defense.gov/Newsroom/Releases/Release/Article/2400993/dod-awards-1267-million-contract-action-to-inbios-international-inc-to-increase/
- ↑ "InBios Receives FDA EUA for Zika ELISA."Aug. 19, 2016. http://www.prweb.com/releases/2016/08/prweb13626657.htm
- ↑ "InBios Granted FDA Market Authorization." May 28, 2019. https://www.prweb.com/releases/inbios_receives_fda_market_authorization_for_its_zikv_detect_2_0_igm_capture_elisa_for_a_presumptive_diagnosis_of_zika_virus_infection/prweb16337876.htm
- ↑ "InBios Releases First FDA Cleared Dengue Fever Test in the US" PRWeb. April 22, 2011. http://www.prweb.com/releases/2011/4/prweb8334651.htm
- ↑ FDA permits marketing of first test to help diagnose dengue fever. April 8, 2011. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm250584.htm
- ↑ Design considerations for immunodiagnostics. "IVD Technology" April 1, 2006. http://www.ivdtechnology.com/article/design-considerations-immunodiagnostics?quicktabs_3=0 Archived 2012-03-13 at the Wayback Machine
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