Cellmid signs a supply agreement for a COVID-19 rapid diagnostic
test with the Australian agent of a Therapeutic Good Administration
(TGA) certified Chinese manufacturer
The COVID-19 rapid diagnostic test is CE Marked, TGA and NMPA
(National Medical Products Administration) approved
The test uses virus specific IgG / IgM detection method returning
results quickly, and no requirement for PCR (Polymerase Chain
Reaction) equipment
The test is available immediately and is suitable as a bedside test,
can be used in hospitals, nursing homes, schools, remote areas
and by corporates when administered by healthcare professionals
as well as in pathology labs
SYDNEY, Friday, 27 March 2020: Cellmid Limited (ASX: CDY) is pleased to advise that it
has entered into a supply agreement for a COVID-19 rapid diagnostic test with an
authorized distributor of the manufacturer, Guangzhou Wondfo Biotech Co Ltd.,
supplying Australia.Cellmid will pay a fixed price for each test it will purchase.
Cellmid has placed its first order and Australia Applications Pty Ltd, the authorized
distributor and the counterparty to the agreement, has issued its first invoice.Australia
Applications Pty Ltd is a private company engaged in import / export between
Australia and China.This is the first agreement between the parties and is for a term of
one year.
The COVID-19 rapid diagnostic test was approved as a POCT (point of care test) by
the TGA on 25 March 2020 1 , by the NMPA in China on 24 February 2020 and the test
received CE mark on 5 March 2020.The rapid diagnostic test is already used in several countries including the UK, Belgium, Spain and Germany.It is produced in a TGA
approved facility in China and it is available immediately.
Wondfo's COVID-19 rapid diagnostic test may be used as a bedside POCT, in doctors'
surgeries, pathology labs or in remote sites administered by healthcare professionals.
Cellmid has not entered into any agreement to sell the tests to customers yet.
may enter into trade finance, vendor finance or prepayment arrangement with
customers should it be required to fund larger purchases.Cellmid has not signed such
arrangements and has been able to fund its first order from its own funds.
The COVID-19 rapid test is a small disposable kit that uses a lateral flow colloidal gold-
based detection method against viral specific IgG / IgM, delivering results in no more than 15 minutes, and requires only the most basic of laboratory equipment.
other available COVID-19 detection methods make use of PCR technology to detect
viral RNA which requires skilled technicians, takes several hours to produce a result and
is limited in throughput by the availability of specific laboratory equipment.
“Learning from countries that managed the coronavirus infections well it is clear that
widespread COVID-19 testing, isolation of those testing positive and early treatment
are the best methods to control the spread of infection, while saving lives and medical
resources ”said Cellmid CEO Maria Halasz.“ We are excited to be able to contribute
to Australia's comprehensive effort to manage this pandemic ”she added.
Importantly, the Wondfo COVID-19 rapid diagnostic tests are stable at room
temperature (2-30˚C) for up to one year which, combined with their ease of use, makes
them an attractive option for regional testing or for mobile / rapid screening centers.
The test consists of a small device that requires only 10 microlitres of patient serum or
plasma, or 20 microlitres of whole blood, to be loaded into a receptacle, alongside an
included buffer, which then mixes with viral S protein fragments and migrates along
the device to an area of immobilized capture antibodies.If virus specific IgG or IgM is
present, conjugates are formed, which show up as a distinctive red band on the
device.
Clinical validation studies have been completed by the manufacturer according to Administrative Measures for Registration of In-vitro Diagnostic Reagents by the NMPA
making use of 596 clinical samples and have shown specificity of 99.57% and a
sensitivity of 86.43% on day 3 and 95% on day 5 of infection.Cross comparison of gold
standard PCR based testing with the device showed a 94.93% coincidence, proving
that the device is positioned as an excellent rapid screening tool.Technical validation
studies have shown no cross reactivity with major respiratory pathogens, no
interference from common biological confounders and a kit to kit and intrasample
precision of 100%.
Approved for release by the Board of Directors.
End
Contact:
Maria Halasz, CEO
T +612 9221 6830
@mariahalasz
Cellmid is an Australian life sciences company with a consumer health business and biotech
assets in development.Advangen is Cellmid's wholly owned subsidiary engaged in the
development and sale of first in class, best in class, clinically validated anti-aging products for
hair, skin and body.Advangen has a range of FGF5 inhibitor hair growth products which are
sold in Australia, Japan, USA and China.Advangen has a rich portfolio of hair growth and anti-
aging hair care assets which include formulations of products on market, trademarks, patents
and patent applications, proprietary assays and manufacturing processes.For further
information, please see www.cellmid.com.au and www.evolisproducts.com.au. Cellmid's
wholly owned subsidiary, Lyramid, develops innovative novel therapies and diagnostic tests for
age related diseases including inflammatory and autoimmune conditions.Lyramid holds the
largest and most comprehensive portfolio of intellectual property relating to the novel targets
midkine (MK) globally.
Forward looking statements This announcement may have forward-looking statements that are subject to risks and
uncertainties. Such statements involve known and unknown risks that may cause the actual
results, performance or achievements of Cellmid to be materially different from the statements
in this announcement.Actual results could differ materially depending on factors such as the
availability of resources, regulatory environment, the results of marketing and sales activities
and competition.
