NEWPORT BEACH, Calif., April 03, 2020 (GLOBE NEWSWIRE) — Vivera Pharmaceuticals, Inc. a California based pharmaceutical company, is proud to do its part in delivering safe, effective COVID-19 testing. The Company takes the recent surge in fraudulent testing devices from China and elsewhere seriously.
As production ramps up on Vivera’s CoV-2 Rapid Test kits, Vivera is working closely with state and local governments to develop strong relationships and efficient delivery to communities hardest affected by the pandemic. Vivera’s tests are validated by extensive clinical data from its German manufacturing partners.
As opportunistic importers of cheaply-made testing devices take unfair advantage of rampant fear, the Food and Drug Administration (FDA) cannot move fast enough to shut them down. Chinese manufacturers selling unauthorized, non-FDA-approved, devices are relying on widespread panic in order to amass profit.
“Vivera has followed the rules,” stated Chief Medical Officer, Dr. Stephen McColgan. “We have worked to file a comprehensive Emergency Use Authorization, notified the FDA using the appropriate channels, and are working closely with them to expedite the approval of serological point of care tests.”
CEO Paul Edalat, frustrated by the lack of regulator action against marketers and importers capitalizing on widespread public panic, stated, “We know that many of these Chinese-made tests have no data to back them. You cannot have these bogus tests that cost $10 and give results in 10 minutes sold to the public with fake FDA approval and not expect people to think that is a real solution. CNN has even reported on the bad marketing practices of BioSphere and their CEO’s backtrack.
“They have to do it the right way the first time. FDA is not moving fast enough to approve legitimate tests, and this is allowing too many opportunities for Chinese tests to flood the market. There are lives at stake, and we cannot continue to wait during this crisis,” concluded Mr. Edalat.
As the death toll from COVID-19 in the United States tops 6,000, and healthcare systems are debilitated under the current load of patients, community testing protocols have become even more vital. Point of care serological tests are an important tool for diagnoses and triage. Vivera has been assigned PEUA number 200171 and is working within FDA authorization guidelines for distribution of its CoV-2 Rapid Test devices.
Vivera Pharmaceuticals, Inc. is an innovative, science-driven pharmaceutical company focused on novel therapies for a variety of indications.
In addition to its pharmaceutical and medical device products, the company has global exclusivity to license the patented and patent-pending TABMELT® sublingual drug-delivery system for the pharmaceutical use of therapeutic compounds. The company is vertically integrated with patented technology, manufacturing capabilities, and distribution for its products.
For more information, visit https://viverapharmaceuticals.com or www.ViveraCoV2.com
Director of Public Relations
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Source: Vivera Pharmaceuticals Inc.
Released April 3, 2020