ECVAM evaluation of GARDskin rescheduled to an extra scientific committee meeting in spring 2019
Lund, September 18, 2018 - SenzaGen (Nasdaq First North: SENZA) has been notified by the European Center for the Validation of Alternative Methods (ECVAM) authority that due to time constrains their scientific committee (ESAC) will not be able to evaluate tests in the category ”Test Guidelines on Health Effects”, to which GARDskin belongs, this year. The authority cites high workload as reason for the delay. Instead, ECVAM has announced that the evaluation of GARDskin is now scheduled for an extra meeting to be held during spring 2019.
SenzaGen originally submitted the final validation report for GARDskin to the regulatory authorities in 2018, thereby fully complying with ECVAM and OECD deadlines. The report shows that GARDskin can determine with 93.8% accuracy if chemical substances pose a risk of causing allergies. This result confirms the superiority of GARDskin over all currently available validated methods. It is also the first test to include the long required potency classification in vitro, which is a requirement for registration of chemicals and also requested by customers. GARDskin is unique in that it provides a holistic view by including analysis of multiple human immunological responses in a single test. In addition, GARDskin is the first test to be validated in which biology, genomics and high-tech algorithms are combined, leading to high safety levels.
ECVAM (European Centre for the Validation of Alternative Methods) has announced that because of a high workload the evaluation of GARDskin is now scheduled for an extra meeting to be held in the spring of 2019. This in turn means that a decision by the OECD regarding the validation of GARDskin is now expected in 2020.
"SenzaGen has had a broad marketing strategy from our start and we are constantly working to expand it further. This has involved focusing the company's resources on large markets and applications where demand for regulatory approval is limited and thus our total future revenues are only partially dependent on an OECD validation," says SenzaGen CEO Anki Malmborg Hager.
A telephone conference is scheduled on September 19, 2018, 8:00 am CET to answer questions and further elaborate on this news. The conference will be held in Swedish.
Participant dial in numbers:
SE: +46856642662
UK: +442033645373
On the SenzaGen website, under Investors/Pressmeddelanden (http://senzagen.com/investors/pressmeddelanden/) there will be an MP3 file for those who want to listen to the conference call later, the file is available within two hours of the end of the conference call.
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 www.senzagen.com
This information is information that SenzaGen is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the contact person set out above on September 18, 2018, at 17.30.
SenzaGen AB is listed on Nasdaq First North in Stockholm and FNCA is the company’s Certified Adviser. For more information, please visit www.senzagen.com
