NEW YORK (GenomeWeb) — SenzaGen will next month launch GARDair, a genetic test that the firm believes can determine whether or not various substances and chemicals that come into contact with a person's lungs are allergenic.
The Lund, Sweden-based company is marketing the panel, which runs on NanoString Technologies' nCounter System, to chemical and cosmetics firms as a replacement for animal models.
According to CEO Anki Malmborg Hager, manufacturers are increasingly looking to human genetics to assess the allergenicity of their products, due in part to animal testing bans in certain industries, such as cosmetics, but also the increased accuracy of working with human data.
"In Europe, animal testing has been banned since 2013, and this ban has spread within the cosmetics field," Malmborg Hager said, noting similar bans in California, Brazil, Israel, India, South Korea, and other countries. "This is why interest in in vitro toxicology testing is growing."
Also, as Malmborg Hager noted, the products under evaluation are used by people, not by animals, reducing the reliability of animal models. "Mice don't wear lipstick, humans do," she said. "It makes more sense to look at human cells and the human genome to get an answer. In the end, we are providing safer products to the customer."
Replacing animal models however requires "a lot of data points," Malmborg Hager conceded, one of the reasons for the firm's genome-wide approach. The company's flagship assay, the Genomic Allergen Rapid Detection (GARD) test, was developed by researchers at Lund University, among them Carl Borrebaeck, who now serves as chairman of the company's board.
SenzaGen has traded publicly on Nasdaq's First North index since it went public with a SEK90 million ($106 million) offering last year. The firm currently employs around 20 people, Malmborg Hager said.
Initially, the researchers used Affymetrix arrays to screen cells associated with immune reactions after they were treated with known sensitizers and non-sensitizers. They then developed panels that could distinguish and allergic reaction from a non-allergic response, and the company migrated the panels to the NanoString nCounter system following a review of various multiplexing technologies.
From the start, SenzaGen decided to market its platform to companies, rather than individuals.
"We are not testing if an individual is allergic, we are testing if a product has an ability to cause a reaction," noted Malmborg Hager. "It's a risk assessment." The firm's clients in some cases use the data generated on SenzaGen's platform in their submissions to regulatory bodies so that they can gain authorization to sell their products, she said.
SenzaGen launched its first test, GARDskin, in 2016. The assay measures the gene expression of 200 genes relevant to the skin sensitization adverse outcome pathways, in order to predict the ability of chemicals to induce a reaction. Last year, the firm introduced GARDpotency, a complementary, 52-gene panel, that enables the subcategorization of sensitizers according to the European Commission's Classifying, Labeling, and Packaging (CLP) Regulation.
Guidelines for registering chemicals with the European Chemicals Agency oblige manufacturers to categorize skin sensitizers according to the CLP Regulation.
GARDair is therefore SenzaGen's third commercial assay, and the first to target airway allergies. In 2016, the company received a €2.4 million EU Horizon 2020 grant to develop the assay. SenzaGen also worked with AstraZeneca in preparing GARDair, drawing on the pharma's "expertise in respiratory questions" and using its chemicals to develop the test.
According to Malmborg Hager, the test is being primarily targeted to partners in the chemical, pharmaceutical, and cosmetic industries that wish to determine whether or not their chemicals might induce sensitization of the respiratory tract, leading to occupational asthma.
The company is planning to debut the assay next month at the International Congress on In Vitro Toxicology meeting in Berlin.The company intends to offer the assay via its laboratory in Lund, as well as through its partner laboratories, such as Burleson Research Laboratories in North Carolina, and Eurofins BioPharma Product Testing in Germany. Eurofins also markets the tests worldwide.
Malmborg Hager said the launch of GARDair is in line with SenzaGen's ambitions to introduce a new assay based on the GARD platform each year. "We believe that this is the way to replace animal testing," she said. "You have to have a holistic view of the human system in order to replace an animal."
The company has discussed two assays in development: one targeting protein sensitizers, another focused on complex mixtures of chemicals. Malmborg Hager said these could be marketed for cosmetics and food allergy testing, but did not elaborate on the content of the tests or when they could become available.
Additionally, the company is looking to expand its US office in San Francisco, which it established in 2016. "The US is a huge market and we need more people to work more actively there," Malmborg-Hager said.
While SenzaGen continues to expand its pipeline and workforce, the company is looking to encourage uptake of its GARDskin test. Last week, it announced that the European Center for the Validation of Alternative Methods (ECVAM) had decided to postpone its evaluation of GARDskin. Based in Italy, ECVAM serves as a reference center for acceptance of alternative testing methods aimed at replacing animal testing in different fields. The OECD sets its test guidelines based in part on ECVAM's recommendations. A positive assessment of GARDskin could therefore lead to wider international use of SenzaGen's test.
Malmborg Hager said that the evaluation of GARDskin, which was supposed to take place this year, will instead be carried out in the spring of 2019. The delay will push back any decision by the OECD regarding the validation of GARDskin to 2020, she said.