Lund,
July 9, 2018. SenzaGen (Nasdaq First North: SENZA) announces today that
the company has submitted the official validation report for
GARDpotency™ to the relevant regulatory authorities as a complement to
the validation of GARDskin™. GARDpotency™ is the first animal-free
allergy test on the market that can be used to evaluate chemicals
according to the EU's CLP classification.
Other initiatives to measure potency today, including animal tests, only
reach an accuracy of 55%-69%. Therefore, we at SenzaGen are extremely
happy to be able to present the final results of the report showing that
our test can classify CLP Class 1A and 1B chemical substances,
quantifying the risk of causing allergies with an accuracy of 82
percent, as determined by three laboratories.
Results from the validation demonstrate that the performance of
GARDskin™ together with GARDpotency™ exceeds all currently available
validated methods. Worldwide approval and recommendation from ECVAM (the
EU Reference Laboratory for Alternatives to Animal Testing) and OECD
regarding the use of GARDskin™ and GARDpotency™ are expected in 2019.
GARDpotency™
is based on the same biological platform as GARDskin™ and both tests
are expected to be approved and recommended at the same time. Together
with GARDpotency™, which complements GARDskin™, SenzaGen’s allergy test
will be unique on the market, as it is the only test that offers
animal-free tests of chemicals in line with the EU’s CLP classification.
The CLP classification follows the Global Harmonized System, GHS,
developed by the UN to create common criteria for the classification and
labelling of chemicals.
The EU Chemicals
Agency ECHA, which regulates chemical use based on the REACH Regulation,
requires that chemicals that may induce sensitivity (sensitization)
must be potency-classified according to CLP. This has so far only been
possible with a so-called LLNA (Local Lymph Node Assay) evaluation,
which is an in vivo test using animals. SenzaGen’s GARD™ test platform is based on human cells in vitro and genomic biomarkers, constantly delivering better accuracy than animal tests.
“Potency is
extremely difficult to measure. We are therefore very happy to be able
to report these results. In view of the impressive validation results
for GARDpotency™, we look forward to receiving the authorities’ response
regarding GARDskin™ and GARDpotency™ in 2019. As a consequence of these
good results, we are planning to communicate sales targets for the
coming years during the second half of this year. A positive response
would make our allergy test the first animal-free test that can be used
for classification in accordance with CLP, the EU’s standard,” says Anki
Malmborg Hager, CEO of Senzagen.
The results from the validation report will be presented at forthcoming scientific conferences.
For more information, please contact:
Anki Malmborg Hager, CEO, SenzaGen AB
Email: anki.malmborg.hager@senzagen.com
Telephone: +46 768 284822
About GARD™
GARD is a group of tests for assessing chemical skin
sensitizers. The tests make use of genetic biomarkers for more than 200
genes which cover the entire immune reaction and are relevant to
predicting the risk of hypersensitivity. The tests have over 90 percent
reliability. This compares with the current predominant test method,
experiments on mice, which has an accuracy of 70-75 percent. SenzaGen’s
tests are also capable of measuring the potency of a substance’s
allergenic properties. Consequently, GARD tests provide a much more
comprehensive basis for determining whether a substance should be
classified as an allergen than current testing methods.
About SenzaGen
SenzaGen makes it possible to replace animal experiments with in
vitro genetic testing to determine the allergenicity of the chemicals we
come into contact with in our daily lives, such as for example in
cosmetics, pharmaceuticals, food products and dyes. The company’s
patented tests are the most reliable on the market and provide more
information than traditional evaluation methods. We ourselves sell the
tests in Sweden and the USA, and we sell through partners in several
other countries. Over the next few years the company will expand
geographically, make alliances with more distribution partners and
launch further unique tests. SenzaGen has its headquarters in Lund in
Sweden and a subsidiary in San Francisco, USA. For more information
visit http://www.senzagen.com.
The information was submitted for publication, through the contact person set out above on the 6 July 2018 at 08:50
SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit http://www.senzagen.com.