InBios

Predicting the Next Emerging Disease Requiring In Vitro Diagnostics (IVDs)

Retrieved on: 
Wednesday, October 12, 2022
Chagas, Kalorama, Mosquito control, OraSure Technologies, Method, Infection, Ortho Clinical Diagnostics, Tuberculosis, BGI, Bird, BD (company), Roche, Rift Valley fever, CCHF, Dengue fever, SD, InBios, Spider, World, Qiagen, Marketing, IVD, Siemens Healthineers, World Health Organization, Nipa, Yellow fever, Adult, Lassa fever, Thermo Fisher Scientific, Cepheid variable, Bass, TB, Abbott, Pharmaceutical industry, Vaccine, Chikungunya, West Nile virus, Malaria, Turtle, Bruker, Goldfish, Ross River virus

ARLINGTON, Va., Oct. 12, 2022 /PRNewswire-PRWeb/ -- Kalorama estimates a $3.7 billion market for emerging diseases. This market is expected to grow to $4.9 billion in 2026. This is based on its recent report "Emerging Infectious Disease Market Trends, 2022."

Key Points: 
  • ARLINGTON, Va., Oct.12, 2022 /PRNewswire-PRWeb/ -- Kalorama estimates a $3.7 billion market for emerging diseases.
  • This is based on its recent report " Emerging Infectious Disease Market Trends, 2022 ."
  • For many mosquito-borne illnesses, there is no vaccine and little in the way of treatment as the infections are viral.
  • Non mosquito-spread diseases of concern include: Tuberculosis, Chagas, Lyme Disease Marburg virus, Rift Valley Fever, Ebola, Ross River Virus, CCHF, Nipah and Lassa Fever.

Curebase Solutions Supports Another InBios FDA Emergency Use Authorization for COVID-19 IgG Antibody Rapid Test

Retrieved on: 
Thursday, September 30, 2021
GMP, ISO, Federal Food, Drug, and Cosmetic Act, Infection, Clinical trial, PPA, Time, Diagnosis, FDA, Immunoglobulin G, Patient, Physician, Lviv, InBios, Virus, CEO, NPA, Antibody, EUA, SAN, USDA, Cros, COVID-19, Severe acute respiratory syndrome coronavirus 2, Research, Laboratory, Pharmaceutical industry, Medical device, Vaccine

This research resulted in FDA Emergency Use Authorization (EUA) for use in the United States.

Key Points: 
  • This research resulted in FDA Emergency Use Authorization (EUA) for use in the United States.
  • The InBios test includes all reagents and controls required to run 50 test specimens with results in approximately 20 minutes.
  • This rapid test is intended to identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
  • While the SCoV-2 Detect IgG Rapid Test has not been FDA cleared or approved, it has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.

FDA Authorizes Everlywell's COVID-19 Test Home Collection Kit DTC for Direct to Consumer Purchase

Retrieved on: 
Wednesday, February 17, 2021
Medicine, Health, Occupational safety and health, COVID-19 testing, Coronavirus disease, Food and Drug Administration, Medical tests, InBios

In May 2020, the FDA issued Everlywell the first EUA of its kind for the Everlywell COVID-19 Test Home Collection Kit, which launched to consumers in June 2020.

Key Points: 
  • In May 2020, the FDA issued Everlywell the first EUA of its kind for the Everlywell COVID-19 Test Home Collection Kit, which launched to consumers in June 2020.
  • The Everlywell COVID-19 Test Home Collection Kit DTC is an FDA-authorized mail-in home collection test kit for COVID-19 suitable for adults 18 years and older in all 50 U.S. states.
  • Those options are listed below:
    Adults 18 years and older in all 50 U.S. states can now purchase an Everlywell COVID-19 Test Home Collection Kit DTC in quantities up to 99.
  • Retailers interested in carrying the Everlywell FDA-authorized, diagnostic (PCR) COVID-19 Test Home Collection Kits DTC on shelves or online can contact [email protected] .

InBios Receives FDA Emergency Use Authorization for Second COVID-19 Antibody Test

Retrieved on: 
Wednesday, July 1, 2020
Medicine, Branches of biology, InBios, Immunologic tests, ISO 13485, ELISA, Immunoglobulin M, Biology

Earlier this month, InBios received an FDA EUA for its SCoV-2 Detect IgG ELISA kit.

Key Points: 
  • Earlier this month, InBios received an FDA EUA for its SCoV-2 Detect IgG ELISA kit.
  • In performance studies, InBios' SCoV-2 Detect IgM ELISA kit demonstrated 92.50% sensitivity and 98.95% specificity.
  • About InBios: InBios International Inc. specializes in the design, development and manufacture of diagnostic assays for emerging infectious diseases and biothreats.
  • InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified.