IIVS teams up with labs to validate a non-animal test for regulatory submissions

By Melissa Fassbender

- Last updated on GMT

(Image: Getty/Image Source)
(Image: Getty/Image Source)

Related tags In vitro Toxicology Regulation Charles river laboratories

IIVS is collaborating with global laboratories to validate an improved skin sensitization reactivity method to meet toxicology and regulatory requirements.

The Institute for In Vitro Sciences (IIVS) is a non-profit working to promote rapid and innovative non-animal test methods​.

The global market for in vitro toxicity testing is predicted to reach $8.8bn by 2023​ – and demand is expected to increase, driven by new technologies and regulations, according to a recent report.

Read more: How big data can design safer clinical trials and reduce animal testing

The organization is working with the chemicals company BASF and Givaudan, a developer of flavors and scents, to validate the Kinetic Direct Peptide Reactivity Assay (Kinetic DPRA). The non-animal test is used to predict sensitization, or allergic reactions in the skin.

According to IIVS, while three other non-animal sensitizer tests are internationally accepted, the Kinetic DPRA could potentially “go beyond a yes/no answer”​ to predict a sensitizer’s potency.

Previously, the only way to predict potency classifications – which some regulatory agencies require – was with animal testing.

Erin Hill, IIVS president and co-founder, said the basis of the collaboration is to validate the method – “meaning, can the method be transferred to other laboratories successfully.”

Designed by BASF and Givaudan, the validation project will be conducted over the coming year.

Pending successful validation, the method will be put forward as a prosed Test Guideline​ at the Organization for Economic Cooperation and Development (OECD) in 2019, Hill told us.

As the original method is well established in several laboratories around the world, Hill said the modified assay should be relatively easy for laboratories to implement.

“The fact that this method improves upon an already established non-animal method was highly attractive to us and why we are so pleased to support the validation,”​ she added.

Other participating laboratories include The Procter & Gamble Company (which developed the original DPRA), Charles River, and the Czech National Institute of Public health.

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