SNDD RedHawk Holdings Corporation (CE)

The Registrant announced today that it now offers for sale certain real time SARS-CoV2-RT-PCR clinical tests (“Clinical Test Kits”) and SARS-CoV-2 Antigen Rapid Self Tests (“Home Test Kits”). The Clinical Test Kits and Home Test Kits offered for sale have received Emergency Use Authorization from the United States Food and Drug Administration (“FDA EUA”).

COVID-19 is a respiratory disease caused by infection with SARS-CoV-2 virus. Common signs of infection include respiratory symptoms, fever, cough, breathing difficulties. In severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and death.

The Clinical Test Kits, manufactured in the United States, are intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs and sputum from patients suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

The Clinical Test Kits are a real-time reverse transcription polymerase chain reaction test that includes the assays and controls for a real time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab and sputum specimens from patients who are suspected of COVID-19.

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in sputum and upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infective status.

The Clinical Test Kits are intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

The Home Test Kits are one-step lateral flow chromatographic immunoassay. The test strip in the device includes: (i) a conjugate pad containing anti-SARS-CoV-2’s Nucleocapsid protein antibody, Mouse IgG antibody, all of which are conjugated to colloidal gold, and (ii) nitrocellulose membrane containing a test line (“T-line”) and a control line (“C-line”).

The T-line is coated with anti-SARS-CoV-2’s Nucleocapsid protein antibody, when the specimen is added, it migrates by capillary diffusion rehydrating the gold conjugate, if present in the specimen, SARS-CoV-2’s Nucleocapsid protein and its antibody labeled with colloidal gold formed antigen-antibody complexes. These complexes will continue to migrate along the strip until the T-line, where they are captured by the SARS-CoV-2’s Nucleocapsid protein antibody generating a red violet line in T-line. If the specimen does not contain SARS-CoV-2 or the SARS-CoV-2 is below the lower level, the T-line will not appear.

The C-line is coated with Goat anti-Mouse IgG which should bind to the gold-Mouse IgG antibodies conjugate and form a red violet line regardless of the presence of SARS-CoV-2’s Nucleocapsid protein.

The purchase of the Clinical Test Kits and the Home Test Kits is subject to certain terms and conditions including, but not limited to, product inspection, product testing, and acceptance. The agreement to purchase the Clinical Test Kits and the Home Test Kits is cancelable, among other things, upon the occurrence of material adverse changes in market conditions or the manufacturer’s loss of its FDA EUA.