San Clemente 11/5/2020 1:19:21 PM
News / Business
Global WholeHealth Partners Corp. (GWHP) Announces It Now Offers the New FDA Cleared Fingerstick for Rapid COVID-19 Test Results in Minutes
Global WholeHealth Partners recognize that there is a crucial need for faster testing and faster results when it comes to fighting the COVID
San Clemente, CA, Nov. 05, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- Global WholeHealth Partners recognize that there is a crucial need for faster testing and faster results when it comes to fighting the COVID-19 pandemic. Global WholeHealth Partners know that the quicker the test results can be reviewed by a Front-Line Healthcare Worker, the quicker we can stop the spread of this disease.
Results in minutes versus hours or days with other diagnostic kits, the more lives that can be saved with the only FDA authorized COVID-19 POC serology test.
With the new fingerstick test, healthcare providers can prick a patient’s finger and get results in minutes without having to wait for venous blood. Global WholeHealth Partners will be able to distribute these tests to more urgent cares, hospitals, and – to help curb the spread of CoViD19 SARS2.
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, Nasal Swab Influenza A & B, and Throat Swab Strep A, Urine and Saliva Drug Testing, Whole Blood Mononucleosis, H. Pylori, FOB, and several other tests.”
Global WholeHealth Partners Corp. offers cutting edge technology using In-vitro Diagnostic (IVD) Real-Time PCR test that detects in 1 1⁄2 hours and the Rapid Diagnostic Testing (RDT) Whole Blood, Serum/Plasma that can detect between 10-15 minutes, which predict diseases ahead of its industry competitors.
On September 23, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19. The Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. On September 23, 2020, that EUA was being reissued to authorize the test for POC use using fingerstick blood samples. This authorization means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.
“Authorizing point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D.
FDA Commissioner Stephen M. Hahn, M.D. said, “Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test. As more and more point-of-care serology tests are authorized, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”
The Assure COVID-19 IgG/IgM Rapid Test Device is currently the only FDA authorized COVID-19 POC serology test and is available by prescription only. The FDA continues to work with test developers to expand access to COVID-19 testing.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
For international testing, which is not sold in the USA, but has a Certificate of Exportability by the FDA Certificate No. 2260-11-2019, 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.
Right now, under the FDA guidelines, Global WholeHealth Partners Corp is selling the Covid-19 rt-qPCR Test to high complexity labs or medical institutions that qualify under the FDA guidelines as Global had partnered with 1 Drop, which has received its FDA EUA Authorization. Global WholeHealth Partners Corp is also selling the IgG/IgM Antibody Rapid Test for Covid-19 as they have partnered with Assure which has received its FDA EUA Authorization.
Global WholeHealth Partners Corp recognizes that the size of the COVID Diagnostic Market is expected to grow.
According to a report published by Grand View Research, Inc. on Aug 04, 2020, the COVID-19 Diagnostics Market Size Worth $7.8 Billion By 2027. The report highlighted several key players in the COVID Diagnostic market such us Thermo Fisher Scientific Inc., Abbott Laboratories, Quest Diagnostics Incorporated, Danaher Corporation and Hologic, Inc.
Link to report published by Grand View Research:
Right now, under the FDA guidelines, Global WholeHealth Partners Corp is selling the Covid-19 rt-qPCR Test to high complexity labs or medical institutions that qualify under the FDA guidelines as Global had partnered with 1 Drop, which has received its FDA EUA Authorization. Global is also selling the IgG/IgM Antibody Rapid Test for Covid-19 as Global has partnered with Healgen which has received its FDA EUA Authorization. Now with Assure, Global is selling the POC tests directly to doctors, clinics, and hospitals, without the need for high or moderate complex labs.
For international testing, which is not sold in the USA, but has a Certificate of Exportability by the FDA Certificate No. 2260-11-2019, 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.
Call 1-877-568-GWHP (4947) to become a distributor or buy COVID 19 rapid test rt-qPCR kits or the Antibody IgG/IgM Rapid CoViD 19 test. We offer small sample size test kits, sold in packs of 100.
About Global WholeHealth Partners Corp.:
Global WholeHealth Partners Corp’s Made in the USA Covid-19 Rapid Test Kits 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.
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: investors@gwhpcorp.com
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.
