InBios International, Inc.

Business Name: InBios International, Inc.
Business Genre:
Business Description:

Specializies in “immunodiagnostic devices for infectious dieases and biothreats.” [5]. Primarily produces ELISA and rapid detection antibody tests [6, 7].

City: Seattle
State: WA
Data/Evidence of Effectiveness: Health provider fact sheet states that while the test has been designed to reduce likelihood of false positive results, both false positive and false negative results are possible. Consideration of COVID-19 exposure and associated symptoms are recommended as secondary considerations to the test result [3]. Includes positive control, extraction control, and no template control, which must provide expected results for test to be considered valid [2]. Reported 100% (95% CI: 88.4%-100%) sensitivity and 96.7% (95%CI: 82.8%-99.9%) specificity [4].
Complimentary Products Needed to Perform Test: RNase P Primer and Probe Set(housekeeing gene in clinical sample), Positive Control (three SARS-CoV-2 target RNA sequences in water), Extraction Control (HEK293 cells in Dulbecco’s phosphate-buffered saline), No Template Control (Nuclease-free, molecular-grade water) [2]. Other necessary materials not included in kit outlined in Instructions for Use (IFU) [2, 4].
Setting of Care: “””Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.”” [2].”
Current Status / Clinical Development Stage / Expected Milestones: Not FDA cleared/approved; FDA approved to meet EUA criteria [2]. Under EUA, cGMP requirements have been waived [2]; for in vitro diagnosis of SARS-CoV-2 infection [2].
LOD: 1,100 copies/mL [4]
Funding & Ownership : Private [9], no further information available.
Business Model: Primarily produces and sells ELISA and rapid detection antibody tests [6, 7]. Currently selling their Smart Detect SARS-CoV-2 rRT-PCR Kit, with ELISA and rapid detection antobody tests for COVID-19 under development [8].
IP: Several patents related to ELISA and rapid detection antibody tests (US8399261B2, US20190170751A1), none found for SARS-CoV-2 PCR technology [10].
History & Origins : Founded in 1996, primarily focused on ELISA and rapid detection antibody tests for wide-spread dieases (Dengue, Zika, Chagas, West Nile, Japanese Encephalitis, Scrub Typhus, Visceral Leishmaniasis, Cutaneous Leishmaniasis, Filariasis, Strongyloides, Leptospirosis, Melioidosis, Norovirus) [5, 9, 11].
Date EUA Issued: 04/07/2020 [1]
Sources: [1] [2] [3] [4] [5] [6] [7] [8] [9] [10] [11].
Organization: Information not avaliable
No. Tests Per Day: 93 tests/run x 1 run/4 hours x 24 hours/day= 558 tests/day
Time to Result: Results in ~4 hours [8].
Test Sample Type: nasopharyngeal, anterior nasal, and mid-turbinate nasal swabs [2].
Technology Overview: detects presence of RNA originating from SARS-CoV-2 in samples taken from upper system [2]
Testing Type: qualitative viral RNA test, RT-PCR based [2]
Test Category: RT-PCR
Test Name: Smart Detect SARS-CoV-2 rRT-PCR Kit [1]
Clinical Application & Need: A positive result indicates the patient is actively infected with the virus, and assumed to be contagious [3]
Age of Company: 24 years old, founded in 1996 [9]

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