Cellink AB. (6/23/21). "Press Release: Cellink’s EpiDerm Skin Model Has Been Approved by the OECD as a Stand-alone in-vitro Test Method for Phototoxicity".

	Organisation	MatTek In Vitro Life Science Laboratories (SL)
	Group	Bico (Group)
	Product	EpiDerm™ skin tissue model
	Product 2	toxicological test
	Person	Armento, Alex (MatTek 202103 CEO)
	Person 2	Gatenholm, Erik (Cellink 201908 CEO + Co-Founder)

MatTek Life Sciences, a subsidiary of CELLINK, today announced the acceptance of the EpiDerm™ Phototoxicity Test as part of Test Guideline No. 498 In vitro Phototoxicity: Reconstructed Human Epidermis Phototoxicity Test Method by the Organization of Economic Cooperation and Development (OECD). This effort is very much in line with the Group’s goals to reduce and eventually replace animal testing by developing technologies and methods that are more human-relevant and provide a more accurate prediction of human clinical responses. This is the fourth OECD test guideline validation for MatTek’s in vitro tissue models following validations for Skin Irritation (OECD TG 439), Skin Corrosion (OECD TG 431) and Eye Irritation (OECD TG 492).

Test Guideline 498 is a stand-alone method for evaluating the phototoxic potential of a test chemical after topical application in reconstructed human epidermis (RhE) in the presence and absence of simulated sunlight. Phototoxicity potential is evaluated by relative reduction in viability of cells exposed to the test chemical as compared to the absence of simulated sunlight. Chemicals identified as positive in this test have been found to be phototoxic in clinical evaluations following topical application to the skin.

The project included testing of over 60 compounds on MatTek’s EpiDerm human epidermal skin tissue model, which is currently the only tissue model accepted under the test guideline. EpiDerm, first produced in 1993, has been used to test the phototoxic potential of topically applied drugs and skin care products since 1997. The phototoxicity protocol was first developed by Dr. Manfred Liebsch of ZEBET and refined by Dr. Helena Kandarova, who also spearheaded the OECD acceptance effort.

“This is a big advancement over accepted guidelines, like the 3T3 assay, which uses a mouse fibroblast cell line and is highly over predictive which erroneously disqualifies perfectly viable compounds for personal care products,” said Alex Armento, CEO of MatTek. “This effort is very much in line with our goals to reduce and eventually replace animal testing by developing technologies and methods that are more human-relevant and provide a more accurate prediction of human clinical responses. This new regulatory acceptance is further proof that in vitro tissue models are a better predictive method.”

MatTek produces EpiDerm, along with an expansive catalogue of additional lab-grown human tissues, for shipment to laboratories and researchers around the globe, and performs in-house testing services for industry clients, making it the most diverse and widely available technology of its kind.

For further information, please contact:

Erik Gatenholm, CEO
Phone (Sweden): +46 73 267 00 00
Phone (US): +1 (650) 515 5566
Email: eg@cellink.com

Gusten Danielsson, CFO
Phone (Sweden): +46 70 991 86 04
Phone (US): +1 (857) 332 2138
Email: gd@cellink.com

This is information that CELLINK AB (publ) submitted for publication, through the agency of the contact persons set out above, on June 23, 2021 at 15:00 (CEST).

About CELLINK

Founded in 2016, CELLINK is the leading bioconvergence company in the world that provides technologies, products, and services to create, understand and master biology. With a focus on the application areas of bioprinting, multiomics, cell line development, and diagnostics, the company develops and markets innovative technologies that enable researchers in the life sciences to culture cells in 3D, perform high-throughput drug screening and print human tissues and organs for the medical, pharmaceutical, and cosmetic industries. CELLINK’s products are trusted by more than 2,000 laboratories, including all the top 20 pharmaceutical companies, are being used in more than 65 countries, and have been cited in more than 1,700 publications. CELLINK is creating the future of medicine. CELLINK is listed on the Nasdaq the Stockholm under CLNK B. www.cellink.com

Record changed: 2022-02-05