ProPhase Labs Begins Advanced, Saliva-based Viral PCR Multiplex-Testing for COVID-19, Influenza A & B, and Other Viruses Afte...
February 09 2021 - 8:30AM
ProPhase Labs, Inc. (NASDAQ: PRPH), a diversified medical science
and technology company, has begun new saliva-based, viral RT-PCR
multiplex-testing as a laboratory developed test (LDT)
classification. Emergency use authorization (EUA) applications have
been filed and confirmed by the U.S. Food and Drug administration
(FDA) for its two new testing methodologies. Testing integrates the
Spectrum Solutions saliva self-collection system with a new,
advanced multiplex qPCR platform for the simultaneous RNA detection
of not only SARS-CoV-2 (COVID-19) but also COVID-19 viral
mutations, as well as Influenza A, B, and more.
This new SDNA Viral™ saliva-based testing combo
features pain-free self-collection, 100% in-device viral
neutralization, removes the need for cold-chain storage of samples,
and provides critical sample consistency for optimal accuracy. It
additionally offers patients the most intuitive and safest sample
collection process while delivering the most robust testing
biomaterial for the detection of multiple viral infections or
mutations in a single test.
Spectrum Solutions, innovative medical device
manufacturer and industry leader in bio-sample collection devices,
helped secure the FDA’s very first saliva-based testing EUA and
continues to lead the charge in saliva-based molecular diagnostic
solutions and research. This new, efficient, and cost-effective
multi-viral testing product has been engineered to increase testing
accuracy and overcome the challenges of limited samples and costly
analysis.
This testing provides patients an immediate
diagnostic advantage using a single saliva test to quickly detect
and identify COVID-19, any of its 17+ current viral mutations,
including those first reported in the United Kingdom and now found
throughout the United States as well as Influenza A and B. With
test processing already underway at both ProPhase New York and New
Jersey CLIA certified lab locations, this new, innovative
technology ensures optimal assay reliability, offers numerous
diagnostic advantages over other testing applications, and delivers
the capacity to process more than 60,000 tests per day.
“We are privileged to be working with Spectrum
Solutions, one of the leading life-science companies in the world
on innovative testing solutions for detecting dangerous viruses
including COVID-19,” said Ted Karkus, CEO of ProPhase Labs. Mr.
Karkus added: “This collection device and multiplex testing
methodology deliver significant value to testing that other
platforms have missed. Not only does our methodology identify the
original COVID-19 virus, our assay also has the multiplex
capability of identifying Covid-19 viral mutations. With the FDA
deciding to limit its review of EUA submissions for COVID-19
laboratory developed tests, receiving confirmation of a formal
review from the FDA device division is a great win for all of us.
Our new state-of-the-art molecular diagnostic testing equipment
from Thermo Fisher not only streamlines testing results but
prepares us for additional testing capabilities moving
forward.”
“Testing is the purposeful pursuit of
understanding a disease and a window into each individual’s
personalized response,” said Bill Phillips, Chief Operating Officer
at Spectrum Solutions. Mr. Phillips added: "Without testing,
patients and medical professionals would not be able to make
informed decisions on the proper treatment path. We could not be
more excited to partner with industry front-runner ProPhase Labs on
the new Spectrum SDNA Viral testing solution. The industry needs
more innovative testing collaborations like this, delivering real
actionable insights, to help move us all forward."
This collaboration coupled with other
technologies and innovations will continue to provide a wide range
of laboratory testing services for the diagnosis, screening, and
evaluation of additional diseases. For more information on the
RT-PCR multiplex testing, competitive pricing and some of the
industry’s fastest testing turnaround times, please contact us at
866-7LAB TEST (866-752-2837) or info@prophasedx.com
ABOUT SPECTRUM SOLUTIONS™, SPECTRUM
DNA™
Headquartered in Salt Lake City, Utah, Spectrum
Solutions and its medical device division, SpectrumDNA, focus their
industry expertise on engineering innovative end-to-end solutions
for clinical diagnostic projects and commercial product plans. A
single-source solution provider for medical device development,
manufacturing, custom packaging, kitting, and direct-to-consumer
fulfillment. Their bio-sample collection devices, patented
technologies, and dedicated client services deliver measurable
process optimization, unprecedented efficiency, and unmatched
global scalability. For more information, please visit
spectrumsolution.com/SDNA.
About ProPhase Labs
ProPhase Labs (NASDAQ: PRPH) is a diversified
medical science and technology company with deep experience with
OTC consumer healthcare products and dietary supplements. The
Company is engaged in the research, development, manufacture,
distribution, marketing and sale of OTC consumer healthcare
products and dietary supplements in the United States. This
includes the development and marketing of dietary supplements under
the TK Supplements® brand. The Company’s subsidiary, ProPhase
Diagnostics, Inc. (“ProPhase Diagnostics”), offers COVID-19 and
other Respiratory Pathogen Panel (RPP) Molecular tests. The
Company also continues to actively pursue strategic investments and
acquisition opportunities for other companies, technologies, and
products. For more information visit us at
www.ProPhaseLabs.com.
Forward Looking Statements
Except for the historical information contained
herein, this document contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding our testing capacity goals.
Management believes that these forward-looking statements are
reasonable as and when made. However, such forward-looking
statements involve known and unknown risks, uncertainties, and
other factors that may cause actual results to differ materially
from those projected in the forward-looking statements. These risks
and uncertainties include but are not limited to the scale, scope
and duration of the COVID-19 pandemic, our ability to attract and
retain customer accounts, consumer demand for our lab processing
services, the competitive environment, attracting and retaining
qualified staff, challenges relating to entering into new business
lines, our failure to obtain certain regulatory approvals, our
ability to ramp up our lab’s testing capacity and execute on our
business plan, our ability to obtain necessary equipment and raw
materials, our ability to execute our business plan in a
cost–effective manner, and the risk factors listed from time to
time in our Annual Report on Form 10-K and other SEC
filings.
Investor Contact
Chris Tyson Managing Director MZ Group - MZ North America
949-491-8235 PRPH@mzgroup.uswww.mzgroup.us
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