SAN DIEGO, CA / ACCESSWIRE / July 1, 2020 / Global WholeHealth Partners Corp. (OTC PINK:GWHP) Submitted an Emergency Use Authorization (EUA) Application Submission Number EUA200181 for a "Made In the USA" COVID-19 Diagnostic Test for the Detection of Antibodies of SARS-CoV-2 on April 6 as mentioned in the 8K filing dated April 10, 2020.
Global WholeHealth Partners Corp. (OTC PINK:GWHP) announced today that an application for Emergency Use Authorization (EUA) is under review at the U.S. Food and Drug Administration (FDA) for its "Made in the USA" Antibody IgM/IgG in vitro diagnostic test kit for the independent detection of IgG and IgM antibodies in Serum/Plasma and Whole Blood of patients exposed to the SARS-CoV-2 virus.
Mr. Charles Strongo the Chairman and CEO of Global WholeHealth Partners Corp, said, "The Company's goal is to offer the fastest and most reliable in-vitro diagnostic tests on the market, while keeping ahead in R&D, by offering FDA Approved Troponin I Whole Blood, Influenza A & B, and Strep A. For international testing, which is not sold in the USA but has a Certificate of Exportability #2260-11-2019 by the FDA, are tests like Rapid Ebola, Rapid Dengue Fever Antibody, and Antigen, Rapid Tuberculosis (TB), Rapid Malaria, and many other rapid tests."
The rapid antibody test allows results to be available in 15 minutes or less. The easy to use assay develops three clear lines that confirm the assay validity and the qualitative detection and differentiation of IgM and IgG antibodies to the SARS-CoV-2 virus.
Upon issuance of an EUA, the Antibody IgM/IgG tests will be available for mass distribution to qualified groups.
Right now under the FDA guidelines, GWHP is authorized to sell this Covid-19 rapid test kit to high complexity labs or medical institutions that qualify under the FDA guidelines. The Covid-19 tests have reimbursement rights according to each state's guidelines.
Global WholeHealth Partners Corp's Made In the USA Covid-19 Rapid Test Kit are manufactured in sunny San Diego, California, and are suitable for the qualitative detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood within 15 minutes.
Call 1-877-568-GWHP (4947) to become a distributor or buy "Made In The USA" COVID 19 rapid test kits. We offer small sample size test kits, sold in packs of 25.
About Global WholeHealth Partners Corp.:
Global WholeHealth Partners Corp. provides cutting edge technology using In-vitro Diagnostic (IVD) Real-Time PCR Machines that detect between 11⁄2 hours and Rapid Diagnostic Testing (RDT) Serum Plasma that detect between 15 -20 minutes, which predict diseases ahead of its industry competitors.
By so doing, GWHP has led the fight against vector-borne terminal diseases such as Ebola, ZIKA, Dengue, Malaria, Influenza and Tuberculosis, Corona Viruses, and among other vector-borne diseases. Our vision is to lead the industry in infectious disease diagnostics and provide molecular solutions that lessen the time to diagnose medical results and empower healthcare professionals. For more details: https://gwhpcorp.com
Media Contact:
Name: Charles Strongo,
CEO, Global WholeHealth Partners Corp.
Email: [email protected]
Forward-Looking Statements
This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
SOURCE: Global WholeHealth Partners Corp