Full Press Release Details
Aytu BioScience Announces Receipt of Initial Shipment of 100,000
COVID-19 IgG/IgM Point-of-Care Rapid Tests; Additional 500,000
Initial Shipment of 2-10 Minute COVID-19 Rapid Tests Received at
Company's Englewood, Colorado Facility
CO / ACCESSWIRE / April 1, 2020 / Aytu BioScience, Inc. (NASDAQ:
AYTU) (the Company ), a specialty pharmaceutical
company focused on commercializing novel products that address
significant patient needs
announced today that it has received its first
Coronavirus Disease 2019 ( COVID-2019 ) IgG/IgM Rapid
Test shipment containing 100,000 tests from the manufacturer. The
Company is now in the process of relabeling the test kits to comply
with Food and Drug Administration (FDA) requirements relating to
labeling of COVID-19 serology test kits and expects to begin
filling current backorders and additional incoming orders shortly
the Company expects to receive another 500,000 rapid tests from the
manufacturer in the next two to three weeks in order to fulfill
additional customer orders.
Disbrow, Chief Executive Officer of Aytu BioScience, commented,
We're pleased to have the first 100,000 tests now in
stock at our facility in Englewood, Colorado. The Company is now
preparing the kits for shipment to customers. Following the
completion of the labeling process and final clearance by FDA,
we'll be shipping this initial inventory to healthcare
professionals across the country. While preparing these kits for
distribution, we are also preparing to receive our next shipment of
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. The COVID-19
IgG/IgM Rapid Test is registered with the FDA and listed on the FDA
website as one of the serology tests allowed by the agency to be
commercialized in the United States. The COVID-19 IgG/IgM Rapid
Test is intended for professional use and delivers results between
2 and 10 minutes at the point-of-care.
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
Contact for Media and Investors:
Contact for COVID-19 IgG/IgM Rapid Test-Related