Pandemic: Demand for Diagnostic Testing is Still Outweighing Supply

With the pandemic still surging, diagnostic test companies are under sizable pressure to produce. In fact, according to Barron’s, “The sudden worldwide demand for accurate, high-quality testing is unlike anything the industry has experienced before. Manufacturers are being asked to quickly scale up from millions of tests per month to millions per week, and the materials are not always available to meet the immediate need.” Meanwhile, the World Health Organization has warned the situation could get far worse.

Until a vaccine is deemed safe and effective, we can only hope to manage its spread with the help of COVID-19 tests in hospitals, homes, sports events, airports, schools. Plus, Congress could soon consider legislation to ensure there are enough tests to go around. In fact, according to former U.S. FDA Commissioner Scott Gottlieb, and Dr. Mark McClellan, director of the Duke-Margolis Center for Health Policy. “Washington could contract with commercial labs and point-of-care test manufacturers to develop and maintain diagnostic capacity for a crisis. Think of it as part of the national stockpile. Under such contracts, companies would build more labs and sprinkle them throughout the country so capacity could be available wherever it’s needed.” With demand only increasing, some of the top companies to watch on such news include XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF), Abbott Laboratories (NYSE:ABT), Sorrento Therapeutics Inc. (NASDAQ:SRNE), Sona Nanotech Inc. (OTC:SNANF)(CSE:SONA), and Laboratory Corp. of America Holdings (NYSE:LH).

XPhyto Therapeutics Corp. (CSE:XPHY)(OTC:XPHYF) BREAKING NEWS: XPhyto Therapeutics Corp. a next generation bioscience company, is pleased to announce an update on its rapid COVID-19 (SARS-COV-2) screening test, near-term milestones and the pathway to commercialization.

XPhyto and its exclusive diagnostic partner, 3a-Diagnostics GmbH, are developing a rapid, disposable, point-of-care lateral flow screening test to detect the COVID-19 virus from patient saliva. On July 6, 2020, the Company announced successful validation of its working prototype for concurrent and independent detection of both the COVID-19 virus and viruses in the broader coronavirus family. 3a’s enhanced RNA probe system has demonstrated a detection limit capable of identifying viral RNA at concentrations found in the saliva of symptomatic, pre-symptomatic, and asymptomatic patients as observed and reported by clinicians and scientists in peer reviewed publications.

Test development and optimization is proceeding on an expedited basis at 3a’s research lab in Germany and in collaboration with third party contractors and academic partners. Subject to fast track certification by the German government, XPhyto and 3a are targeting Q1 2021 for European regulatory approval and commercial sales.

Three potential risk factors have been identified that could negatively impact the estimated schedule of milestones: 1) general internal and/or third party delays; 2) delays related to adjustments for usability optimization; and 3) delays associated with the ISO 13485 audit. XPhyto and 3a are actively working to mitigate delay risks and accelerate the estimated schedule wherever possible. The Company will provide ongoing milestone updates in due course and as appropriate.

XPhyto and 3a are developing rapid screening tests for COVID-19 and other pandemic threats, including H1N1 (swine flu) and H5N1 (avian flu), with a specific focus on early pre-symptomatic stages of infection. Screening tests include later flow assay type tests as well as next-generation biosensors delivered via XPhyto’s dissolvable oral drug delivery platform. The product pipeline is comprised exclusively of rapid, low-cost, easy-to-use, saliva-based screening tools that can be self-administered, making them ideal for decentralized population scale screening to control pandemic disease.

Please join us today, Monday, August 10, 2020, for a live presentation at 12:30 PM EST:

The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 pandemic.

Other related developments from around the markets include:

Abbott Laboratories (NYSE:ABT) announced financial results for the second quarter ended June 30, 2020. "Our diversified business model has proven to be a true strength during this time," said Robert B. Ford, president and chief executive officer, Abbott. "We're a leader in the global COVID-19 testing efforts, we've continued to advance our pipeline and, importantly, we saw significant improvements in growth trends throughout the quarter in the business areas that were initially most impacted by the pandemic."

Sorrento Therapeutics Inc. (NASDAQ:SRNE) announced it has entered into a licensing agreement with Columbia University for the rights to a rapid, one-step diagnostic test that detects SARS-CoV-2 virus in as little as 30 minutes from a sample of saliva. Unlike other commercially available diagnostic products, the test developed by Columbia's team, to be marketed by Sorrento under the COVI-TRACE name, holds all of the testing materials in a single tube and requires no specialized laboratory equipment, making it easily deployable for point of care, on-site or potentially at-home testing. Current diagnostic tests for SARS-CoV-2 detect viral ribonucleic acid (RNA) but must be shipped to a reference laboratory unless the facility collecting the samples has purchased costly instrumentation, cartridges and consumables to extract viral RNA from the fluid in which the sample — either a nasopharyngeal swab or saliva — is placed. The current backlog in SARS-CoV-2 testing has resulted in average turnaround times of between several days to over a week, and laboratories across the country are reportedly struggling to keep up with increased testing demand.

Sona Nanotech Inc. (OTC:SNANF)(CSE:SONA) a developer of rapid, point-of-care diagnostic tests, is pleased to announce that its rapid detection, COVID-19 antigen test’s laboratory validation studies of performance levels have resulted in a test sensitivity of 96%, test specificity of 96% and a Limit of Detection of 2.1 x 102 TCID50.  Sales of the tests will now be permitted under a ‘research use only’ label until full regulatory authority is granted, in relevant territories, at which time the ‘research use only’ label requirement would be lifted, as discussed below.  Technology transfer to manufacturers is currently underway to produce tests to meet current and expected demand.  The Company will provide an update on sales progress and manufacturing delivery timetables in the coming weeks. MRIGlobal, using live COVID-19 viral cultures, determined the test to have a limit of detection of 2.1 x 102 TCID50 which corresponds to an ability to detect the virus in patients with ‘low’ viral loads in 10-15 minutes, as compared to RT-PCR testing which typically takes 24-48 hours to detect the virus. Limit of detection is the minimum amount of target microorganisms that can be reliably detected under optimal conditions and is an essential step in determining the sensitivity of any assay. Current studies show positive COVID-19 patients presenting symptoms have viral loads in the 104 – 106 range.

Laboratory Corp. of America Holdings (NYSE:LH)  a leading global life sciences company that is deeply integrated in guiding patient care, announced plans to create a program to offer total antibody testing at no charge through the patient’s doctor in support of increased blood plasma donations for use as a possible COVID-19 treatment. LabCorp is proud to be part of The Fight Is In Us coalition to increase donations of blood plasma with COVID-19 antibodies. Blood plasma is being evaluated as a possible treatment for patients with an active COVID-19 infection. Public health authorities have asked for help with expanding the population of potential plasma donors, and LabCorp is seeking to meet that challenge by creating a program to offer total antibody testing at no charge through the patient’s doctor. Patients who are interested in donating blood plasma can speak with their doctor about the total antibody testing program during their next routine visit or treatment. LabCorp is currently working with public health authorities and the provider community on the details of the three-month program and will provide additional information in the near future.

Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Winning Media is only compensated for its services in the form of cash-based compensation. Pursuant to an agreement Winning Media has been paid three thousand five hundred dollars for advertising and marketing services for XPhyto Therapeutics Corp. by a third party. We own ZERO shares of XPhyto Therapeutics Corp. Please click here for full disclaimer.

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