PALM BEACH, Fla., Nov. 5, 2020
FinancialNewsMedia.com News Commentary
PALM BEACH, Fla., Nov. 5, 2020 /PRNewswire/ -- COVID-19 tests are critical in the management of the ongoing COVID-19 pandemic for accurate diagnosis as well as for tackling the spread of the infection. Over 600 SARS-CoV-2 diagnostic tests are either approved or are in the development phase for clinical use. Therefore, an increase in the need for developing diagnostic tests is anticipated to drive the market growth. The current status of lead COVID tests is toward rising capacity but mixed accuracy. For efficient and accurate COVID-19 diagnosis, clinicians need a portable or an on-site diagnostic test for real-time management of patients in minimal time. This has encouraged the adoption of Point-of-Care (POC) testing for diagnosis, primarily aimed at reducing the assay duration from hours to a few minutes. The global COVID-19 diagnostics market size is valued at USD 19.8 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 3.1% from 2021 to 2027 and a report from Grand View Research focused on the detection kits market saying that the global Covid-19 detection kits market size is expected to reach $4.63 billion by 2027, and is projected to register a CAGR of 5.05% during the forecast period. It said that: "the COVID-19 pandemic has posed several challenges to the global healthcare systems. The diagnostics area is recognized as one of the primary elements of efforts to contain the spread and circumvent its adverse impact globally. As a result, companies are ramping up their production process to meet the demand or kits and reagents as well as at-home tests, thereby driving the market revenue." Active Companies in the industry include Quest Diagnostics (NYSE: DGX), Global WholeHealth Partners Corporation (OTCPK: GWHP), Abbott Laboratories (NYSE: ABT), Hologic, Inc. (NASDAQ: HOLX), Co-Diagnostics, Inc. (NASDAQ: CODX).
The Grandview Report continued: "The availability of smart testing solutions is expected to boost market growth in the near future. In recent times, the utility of serology tests has expanded with the initiation of multiple SARS-CoV-2 serological surveys globally, thus propelling the demand for these tests. Most of the countries have expanded testing sites by the establishment of drive and walk-through testing centers. These testing centers reduce the waiting time as well as minimize the risk of contagion to healthcare professionals. At-home sample-collection techniques have also emerged as comparatively safer options for the detection of the coronavirus. The confluence of these factors addresses the challenges pertaining to the shortage of supplies and a limited number of testing sites. The advent of new cutting-edge testing technologies to mitigate the adverse impact of the current pandemic is anticipated to foment the organic revenue growth of players engaged in supplying detection kits."
Global WholeHealth Partners Corporation (OTCPK: GWHP) BREAKING NEWS: Global Whole Health Partners Corp. (GWHP) Announces It now offers the new FDA cleared "Fingerstick" for rapid COVID-19 test results in minutes - Global WholeHealth Partners Corp., a developer, manufacturer and provider of Made in the USA Covid-19 Rapid Test Kits based in San Clemente, CA announces it offers the New "Fingerstick" For Rapid COVID-19 Test Results in Minutes with FDA Clearance for Emergency Use, by partnering with Assure.
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.
To Read the Entire Press Release for GWHP, please visit:
Other recent developments in the markets include:
Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, and Catapult Health, the leading national provider of employer-sponsored Preventive Checkups, have recently formed a collaboration designed to help organizations facilitate virtual (telehealth) access to clinical services for their employees and adult dependents, with emphasis on reducing risks related to preventable chronic diseases.
The first-of-its-kind collaboration specifically focuses on helping employers create a highly convenient and safe way for employees to access thorough and guideline driven preventive care and mental health support during the COVID-19 pandemic. Research shows many individuals are reluctant to seek in-person health care due to fear of contracting the SARS-CoV-2 virus, raising the prospect that untreated, preventable conditions will progress to more advanced disease.
Demand for Abbott Laboratories (NYSE: ABT) portfolio of tests for COVID-19 is surging around the world as the pandemic rages on, the company said recently in a Forbes article.
Abbott, which sells an array of established drugs, medical devices for people with diabetes and diagnostics, said COVID-19 diagnostic-testing related sales were $881 million of the company's global sales of $8.9 billion, the company said in its third quarter earnings report.
"We have sold more than 100 million Covid tests across our diagnostic platforms," Abbott chief executive officer Robert Ford told analysts Wednesday morning on a 55-minute call to discuss the global medical product company's third quarter earnings.
Hologic, Inc. (NASDAQ: HOLX) recently announced that it has been awarded a $119 million contract from the United States government to expand its production capacity for COVID-19 molecular tests. The contract will support capital and labor investments enabling Hologic to provide 13 million COVID-19 tests per month for the U.S. market by January of 2022.
Hologic's Panther Fusion® SARS-CoV-2 Assay and Aptima® SARS-CoV-2 Assay received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration in March 2020 and May 2020, respectively. The tests run on the Company's fully automated Panther Fusion® and Panther® systems, which provide initial results in approximately three hours and process more than 1,000 tests in 24 hours. More than 2,000 of these systems have been installed in clinical diagnostic laboratories around the world, including in all 50 U.S. states.
Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, recently announced that Access Genetics, LLC dba OralDNA® Labs, a CLIA-certified customer who uses the Company's Logix Smart™ COVID-19 kit in their FDA authorized OraRisk® COVID-19 RT-PCR test, recently received an amended Emergency Use Authorization (EUA) allowing testing from a saline oral rinse collection.
Dwight Egan, CEO of Co-Diagnostics, remarked: "We are pleased that Co-Diagnostics technology is being used in the first FDA EUA for a test using a simple saline 30 second swish and gargle collection. Because it eliminates the need for a nasal swab, oral rinse technology has the potential to dramatically improve comfort and accessibility of testing in our communities and we believe this authorization by the FDA provides additional confirmation of the quality, versatility, and adaptability of our CoPrimer™ platform."
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