A WORLD-CLASS BIOTECHNOLOGY ENTERPRISE
Xiamen Biotime Biotechnology Co., Ltd., or BIOTIME, is a Portfolio Company of Pasaca Capital Inc. (CALIFORNIA).
Founded in 2008, Xiamen Biotime Biotechnology Co., Ltd. is a biomedical technology enterprise, well-known globally as Biotime. Their industry-leading antibody test delivers the most accurate testing solution available for detecting IgG and IgM antibodies and fighting against COVID-19.
BIOTIME specializes in research and development and in the production of point-of-care testing (POCT), in-vitro diagnostic devices, and reagents.
The company utilizes two, patented technologies including the Fluorescent Rare-Earth Immunochromatography Method with nanoparticles as a marker and its detection test paper. BIOTIME has developed more than 40 POCT, in-vitro diagnostic reagents, holds multiple immunofluorescence analyzer medical device product registrations and CE certificates.
BIOTIME hase successfully developed 42 CFDA approved POCT kits and instruments for the analysis of tumor and cardiac markers, hormones, diabetes, infections, and kidney diseases, of which 9 include diagnostic kits for detecting thyroid-stimulating hormone (TSH), Progesterone, and hCG. Their quantitative assays are based on the fluorescent lateral flow immunoassay platform, including the BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test, which the U.S. Food & Drug Administration (FDA) granted an Emergency Use Authorization (EUA) on July 24, 2020.
EUA filing submitted on March 16, 2020 (FDA EUA Submission Number: PEUA200265)
Data submitted for FDA review, May 2020/June 2020 - FDA in-house, laboratory evaluation completed
EUA granted: July 24, 2020
NOTE: This test has not been FDA cleared or approved;
This test has been authorized by FDA under an EUA for use by authorized laboratories;
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test” Instructions for Use available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use
Fact Sheet for Healthcare Providers: Xiamen BIOTIME BiotechnologyBIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test
Fact Sheet for Recipients: Xiamen BIOTIME Biotechnology-BIOTIME SARSCoV-2 IgG/IgM Rapid Qualitative Test
BIOTIME MISSION - PROVIDING THE HIGHEST-QUALITY HEALTHCARE SOLUTIONS
BIOTIME aims to continue developing superior, in-vitro diagnostic technologies that provide better solutions for healthcare, benefitting people all over the world.
BUILT WITH AN ADVANCED, GERMAN MEMBRANE
The BIOTIME SARS-CoV-2 test contains a German Nitrocellulose membrane, the most advanced membrane in the world.
The BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test is a rapid, qualitative, and convenient in-vitro assay using the Colloidal Gold Immunochromatography Method (nanoparticles) for the differential detection of IgM and IgG antibodies to the COVID-19 virus in human serum, plasma, or whole blood samples.
REGISTERED WITH THE MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA) (UK)
Xiamen Biotime is registered with the MHRA.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom and is responsible for ensuring that medicines and medical devices work and are acceptably safe.
EVALUATED BY BRITAIN'S NATIONAL HEALTH SERVICE (NHS)
NHS M.D.'s Comments regarding the BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test:
“We have performed tests using the Biotime COVID-19 serology test on 50 PCR confirmed patients. The test picked up every, single infected patient. To further elaborate, the test picked up IgM positives in early-stage disease, IgG positives in later-stage disease, and IgM/IgG positive in mid-stage. We are very pleased with these findings and are recommending the service approve these tests.”