Aytu BioScience Secures Exclusive U.S. Distribution Agreement for Coronavirus 2019 (COVID-19) Point-of-Care Rapid Test. Company Expects to Pursue Commercial Use Under FDA's Emergency Use Authorization
ENGLEWOOD, CO / ACCESSWIRE / March 10, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it signed an exclusive distribution agreement for the right to commercialize a clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test. The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation), which licensed North American rights from product developer Zhejiang Orient Gene Biotech Co., Ltd. The test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This exclusive agreement grants Aytu the exclusive right to distribute the product in the United States for a period of three years, with additional three-year autorenewals thereafter.
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 been validated in a 113 patient clinical trial and has received CE marking. It is currently one of only a few tests used for coronavirus screening in China.
Test Features:
Results reported in 2-10 minutes
Facilitates patient treatment decisions quickly
Simple, time-saving procedure
Small specimens, only 5 µL of serum/plasma or 10 µL of whole blood specimens required
All necessary reagents provided & no equipment needed
High sensitivity and specificity
Clinical Results
The COVID-19 IgG/IgM Rapid Test was evaluated with 113 blood samples obtained from patients exhibiting pneumonia or respiratory symptoms. All samples were tested using the Orient Gene diagnostic device, and the results were compared to RT-PCR or clinical diagnosis (including chest Computed Tomography and clinical signs and symptoms) of Novel Coronavirus pneumonia.
Clinical results using the COVID-19 IgG/IgM Rapid Test show:
The sensitivity of the lgM test is 87.9% (87/99) and specificity is 100% (14/14) when compared to RT-PCR.
The sensitivity of the lgG test is 97.2% (35/36) during patients' convalescence period and specificity is 100% (14/14).
The Company expects to pursue U.S. regulatory clearance and expects to consult with the U.S. Food and Drug Administration about qualifying the test under FDA's Emergency Use Authorization.
The Company expects to receive an initial product shipment in three to four weeks, pending the timing of required regulatory, customs, and importation activities.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "The safety and health of every American is of paramount importance to the company as we face the threat of the coronavirus. We are excited to be able to work with U.S. regulatory authorities, and we will work to make this important test available in the U.S. as soon as possible. Coronavirus is a major global health concern, and we are proud to be in a position to help clinicians address this very serious public health concern.
ENGLEWOOD, CO / ACCESSWIRE / March 10, 2020 / Aytu BioScience, Inc. (AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced today that it signed an exclusive distribution agreement for the right to commercialize a clinically validated and commercially used coronavirus 2019 (COVID-19) IgG/IgM Rapid Test. The test has been licensed from L.B. Resources, Limited (a Hong Kong Corporation), which licensed North American rights from product developer Zhejiang Orient Gene Biotech Co., Ltd. The test is intended for professional use and delivers clinical results between 2 and 10 minutes at the point-of-care. This exclusive agreement grants Aytu the exclusive right to distribute the product in the United States for a period of three years, with additional three-year autorenewals thereafter.
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 been validated in a 113 patient clinical trial and has received CE marking. It is currently one of only a few tests used for coronavirus screening in China.
Test Features:
Results reported in 2-10 minutes
Facilitates patient treatment decisions quickly
Simple, time-saving procedure
Small specimens, only 5 µL of serum/plasma or 10 µL of whole blood specimens required
All necessary reagents provided & no equipment needed
High sensitivity and specificity
Clinical Results
The COVID-19 IgG/IgM Rapid Test was evaluated with 113 blood samples obtained from patients exhibiting pneumonia or respiratory symptoms. All samples were tested using the Orient Gene diagnostic device, and the results were compared to RT-PCR or clinical diagnosis (including chest Computed Tomography and clinical signs and symptoms) of Novel Coronavirus pneumonia.
Clinical results using the COVID-19 IgG/IgM Rapid Test show:
The sensitivity of the lgM test is 87.9% (87/99) and specificity is 100% (14/14) when compared to RT-PCR.
The sensitivity of the lgG test is 97.2% (35/36) during patients' convalescence period and specificity is 100% (14/14).
The Company expects to pursue U.S. regulatory clearance and expects to consult with the U.S. Food and Drug Administration about qualifying the test under FDA's Emergency Use Authorization.
The Company expects to receive an initial product shipment in three to four weeks, pending the timing of required regulatory, customs, and importation activities.
Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "The safety and health of every American is of paramount importance to the company as we face the threat of the coronavirus. We are excited to be able to work with U.S. regulatory authorities, and we will work to make this important test available in the U.S. as soon as possible. Coronavirus is a major global health concern, and we are proud to be in a position to help clinicians address this very serious public health concern.
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