04/10/2020
Vivera Pharmaceuticals powered by PharmAct AG
Rapid Test for COVID-19
Vivera Pharmaceuticals, Inc., a pharmaceutical
company focused on putting patients first,
today announces a new partnership with
Pharmact AG, a leading German manufacturer
of rapid diagnostic testing kits. The CoV-2
Rapid Test is an easy to use, rapid diagnostic
tool for determination of COVID-19 infection
in patients displaying clinical symptoms.
Vivera has obtained exclusive rights to market
and distribute the test in the United States.
As part of this, Vivera has submitted an
Emergency Use Authorization application to
the FDA. Under the EUA, the CoV-2 Rapid Test
is intended to detect SARS-CoV-2 antibodies
IgM and IgG in patients. Unlike other tests
currently marketed, the CoV-2 Rapid test can
further determine infection phase. A positive
IgM value indicates an infection in the early
phase of the disease (4 to 10 days), and a
positive IgG value indicates a later phase
(from 11 - 24 days). Results are available in 20
minutes, and require only two drops of blood
from the patient.
“These kits are designed for rapid in the field
testing,” says Dr. Stephen McColgan, Vivera’s
Chief Medical Officer. “When you have
thousands of potential patients, you do not
have time to wait for labs that can only process
a few hundred test results a day. Infection
phasing is important to adequately triage
patients immediately.”
Pharmact CEO Eric Schaber said in a
statement. “We are confident that our pointof-care tests will be critical to help tackle what
is a global pandemic. We are looking forward
to exclusively working with Vivera to import
and distribute our tests in the United States.
Their footprint and expertise means more
patients can be helped more efficiently.”
Vivera founder and CEO, Paul Edalat, further
stated. “We look forward to working with
Pharmact to assist in treating this global crisis.
As a company Vivera focuses on therapies
that put patients first. President Trump has
announced that he is asking all pharmaceutical
and medical companies to do their best to
assist in this crisis. On behalf of Vivera we are ready and
willing to do our part.”
Cost: USD $95.00 / test
Timeline for Delivery: As soon as payment is made for the
tests, the order will be processed. From that date, we expect
to ship the kits within 7-14 days.
Is the product FDA approved? The Vivera Pharmaceuticals
powered by Pharmact AG CoV-2 Rapid Test is not FDA
cleared or approved and can only be used for the duration
of the coronavirus emergency under its Emergency Use
Authorization (EUA) under section 564 of the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
If you are interested in purchasing tests, please contact Tina
Danforth at [email protected]
About Vivera Pharmaceuticals, Inc.
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 cannabinoid compounds. The
company is vertically integrated with patented technology,
manufacturing capabilities and distribution for its products.
