Full Press Release Details
Aytu BioScience Submits Notice of
Commercialization to the FDA, Allowing for Company's
Distribution of its 2-10 Minute COVID-19 IgG/IgM Point-of-Care
Commercial Distribution of First 100,000 Tests to Commence Upon
Receipt of Inbound Product Shipment
CO / ACCESSWIRE / March 23, 2020 / Aytu BioScience, Inc. (NASDAQ:
AYTU), a specialty pharmaceutical company focused on
commercializing novel products that address significant patient
announced today that it has received confirmation
from the U.S. Food and Drug Administration (FDA) that the company
may begin distribution of its Coronavirus Disease 2019
( COVID-2019 ) IgG/IgM Rapid Test throughout the United
States. The COVID-19 IgG/IgM Rapid Test is intended for
professional use and delivers results between 2 and 10 minutes at
expects delivery of its first shipment of 100,000 tests this week.
The initial product shipment is in transit from the manufacturer
and, upon receipt, will undergo FDA and U.S. Customs and Border
Protection (CBP) clearance processes. The test kits will then be
repackaged to comply with FDA's labeling requirements under
the most recent coronavirus guidance for serological test kit
manufacturers. The Company has been in discussions with healthcare
distributors, healthcare institutions, medical practices, and
government agencies and is working rapidly to distribute the test
into the U.S. healthcare supply chain.
Disbrow, Chief Executive Officer of Aytu BioScience, commented,
We are moving as quickly as we can to bring the COVID-19
IgG/IgM Rapid Test to the U.S. professional medical community. With
product now in transit to our warehouse in Colorado we're
optimistic that we can have test kits ready for sale in the very
near term. In the two short weeks since signing our distribution
agreement, we have ordered our first 100,000 tests and have
received confirmation from FDA that we may begin distribution. We
are optimistic that we're now just days away from placing
these COVID-19 test kits into the hands of healthcare
COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic
assay used in the rapid, qualitative and differential detection of
IgG and IgM antibodies to the 2019 Novel Coronavirus in human whole
blood, serum or plasma. This point-of-care test has been validated
in a 126 patient clinical trial and is CE marked.
About Aytu BioScience, Inc.
BioScience is a commercial-stage specialty pharmaceutical company
focused on commercializing novel products that address significant
patient needs. The company currently markets a portfolio of
prescription products addressing large primary care and pediatric
markets. The primary care portfolio includes (i) Natesto , the
only FDA-approved nasal formulation of testosterone for men with
hypogonadism (low testosterone, or "Low T"), (ii) ZolpiMist ,
the only FDA-approved oral spray prescription sleep aid, and (iii)
Tuzistra XR, the only FDA-approved 12-hour codeine-based
antitussive syrup. The pediatric portfolio includes (i)
AcipHex Sprinkle , a granule formulation of rabeprazole
sodium, a commonly prescribed proton pump inhibitor; (ii) Cefaclor,
a second-generation cephalosporin antibiotic suspension; (iii)
Karbinal ER, an extended-release carbinoxamine
(antihistamine) suspension indicated to treat numerous allergic
conditions; and (iv) Poly-Vi-Flor and Tri-Vi-Flor , two
complementary prescription fluoride-based supplement product lines
containing combinations of fluoride and vitamins in various for
infants and children with fluoride deficiency. Aytu recently
acquired exclusive U.S. distribution rights to the COVID-19 IgG/IgM
Rapid Test. This coronavirus test is a solid phase
immunochromatographic assay used in the rapid, qualitative and
differential detection of IgG and IgM antibodies to the 2019 Novel
Coronavirus in human whole blood, serum or plasma. This
point-of-care test has been validated in a 113 patient clinical
trial and has received CE marking.
recently acquired Innovus Pharmaceuticals, a specialty
pharmaceutical company commercializing, licensing and developing
safe and effective consumer healthcare products designed to improve
men's and women's health and vitality. Innovus commercializes over
thirty-five consumer health products competing in large healthcare
categories including diabetes, men's health, sexual wellness and
respiratory health. The Innovus product portfolio is commercialized
through direct-to-consumer marketing channels utilizing the
company's proprietary Beyond Human marketing and sales
strategy is to continue building its portfolio of
revenue-generating products, leveraging its focused commercial team
and expertise to build leading brands within large therapeutic
markets. For more information visit aytubio.com and visit
innovuspharma.com to learn about the company's consumer healthcare
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