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| 8-K - CURRENT REPORT - AYTU BIOPHARMA, INC | aytu_8k.htm |
Exhibit 99.1
Aytu BioScience Announces Positive Results from an Independently
Conducted Clinical Study of the Company’s Licensed COVID-19
IgG/IgM Point-of-Care Rapid Test
Independent
clinical study demonstrates test accuracy of 98.0% and 94.1% for
IgG and IgM, respectively, when using PCR-positive cases as true
positives
ENGLEWOOD,
CO / ACCESSWIRE / April 16, 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 results from an
independent clinical study using the Company’s licensed
Coronavirus Disease 2019 (“COVID-19”) IgG/IgM Rapid
Test were published in the journal Infection Ecology & Epidemiology,
further validating the accuracy, specificity and performance of the
antibody rapid test.
In this
recently published clinical study which included 29 COVID-19
positive cases confirmed by PCR and 124 healthy donors, the rapid
test showed an overall specificity of 100% and 99.2% for IgM and
IgG, respectively. The authors note, “The high negative
predictive value indicates that the rapid test will be useful for
detecting past infections and possible immunity, which may be
crucial for restoring social functions after
lockdown.”
Capillary
blood samples or serum from PCR-confirmed COVID-19 patients were
analyzed with results from the COVID-19 IgG/IgM Rapid Test.
Sixty-nine percent of samples from PCR-confirmed COVID-19 patients
tested IgM positive, and 93.1% tested IgG positive. These results
are well in line with the previously reported specificity of 91.9%
for IgG and IgM. The authors note that variability in samples
obtained during COVID-19 disease or convalescence period means that
in the PCR-confirmed cases, antibodies may not yet have had time to
develop. If this were the case, sensitivities of the test could
actually be higher.
Josh
Disbrow, Chief Executive Officer of Aytu BioScience, commented
“This independently conducted study, which was peer-reviewed
and published earlier this week, demonstrates the clinical
performance of this COVID-19 IgG/IgM rapid test and establishes the
test’s utility in understanding a patient’s past
exposure to COVID-19 and its potential to assess patient immunity
as we move past this pandemic and get our society back to work. We
are happy to see a leading clinical institution further establish
the clinical utility of this important serological
test.”
The
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 now been
validated in multiple independent trials and is CE
marked.
https://www.tandfonline.com/doi/full/10.1080/20008686.2020.1754538
About Aytu BioScience, Inc.
Aytu 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.
Aytu 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
platform.
Aytu's 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
products.
Contact for Media and Investors:
James Carbonara
Hayden
IR
(646)
755-7412
james@haydenir.com