Cellmid Limited (ASX:CDY) has had the authorisation from Guangzhou Wondfo Biotech Co Ltd (SHE:300482) extended for Australia Application Pty Ltd to be a distributor of the Wondfo SARS-CoV-2 antibody test in Australia until December 30, 2020.
The company has also amended the agreement with Australia Application for Cellmid to be a distributor of the Wondfo test in Australia until December 30, 2020, with the previous minimum order requirements removed.
The amended agreement is subject to Cellmid maintaining registration of the product with the Australian Therapeutic Goods Administration.
Both the agreements would be extended beyond December 30, 2020, with written consent.
Cellmid shares have been as much as 20% higher today to 12 cents.
Antibody tests for clinical management
As the pandemic progresses in the coming months, it is Cellmid’s opinion that serological testing, including rapid tests, will have an important role in widespread population surveys as well as in research and development activities such as drug and vaccine trials and as an adjunct device in diagnostic and triage settings.
The company also pointed to a recent peer-reviewed article by the Doherty Institute in Nature Medicine around the utility of antibody tests in clinical management of COVID-19 patients In countries where the incidence of the disease has been significantly higher, such as Spain, Germany and the United States, where population-wide seroprevalence studies have commenced.
The company is confident its agreement extensions maintain its ability to participate in this potential market.
The Wondfo test
The test was recently tested by the Doherty Institute, on behalf of the TGA.
In the most relevant period of 14+ days following the onset of symptoms, it was shown to have the equal highest sensitivity of the tests reviewed so far.
Clinical validation studies have also been completed for the Wondfo Test by the manufacturer according to Administrative Measures for Registration of In-vitro Diagnostic Reagents by the Chinese Food and Drug Administration, reporting sensitivity in the most relevant period of 14+ days following the onset of symptoms consistent with those achieved in the Doherty Institute review.
Cellmid has broadened the SARS-CoV-2 diagnostic product range it can offer to its customers by making introductions to Emergence Technology Pty Ltd which has arrangements to supply both antibody and nucleotide tests.
The Wondfo Test is an important component of this suite of tests.