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Bioprinting BICO Endorses FDA Modernization Act of 2021

ST Medical Devices

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The Swedish firm BICO, formerly CELLINK, has endorsed the FDA Modernization Act of 2021. Formally known as H.R. 2565/ S. 2952, the bill would replace major portions of the 1938 Federal Food, Drug, and Cosmetic Act, specifically those which mandate that all new products be subject to animal-testing for safety and efficacy prior to hitting the market. BICO encompasses 13 companies, whose activities include bioprinting, drug screening and toxicity assessment, and complex 3D modeling of cells and human biological systems, which serve as replacements in pre-clinical testing for research done on animals.

Erik Gatenholm, co-founder and CEO BICO Group, explained in a press release, “There is no bigger ethical issue plaguing the life sciences industry in the United States today than this mandate on animal experimentation. Passing this law is not only the right thing to do, but also will advance Health 4.0 and ensure the U.S. continues to be a global life science leader in the coming decades.”

Ending medical and cosmetic testing on animals has been a priority for BICO since the company’s inception. Earlier this year, one of BICO’s subsidiary companies, MatTek Life Sciences, announced the acceptance of its patented EpiDerm Photoxicity Test by the Organization of Economic Cooperation and Development (OECD), as part of the OECD’s latest testing guidelines for in vitro assays.

Essentially, in vitro assays use a combination of CAD software and bioprinting to quickly fabricate human tissue samples, which can be used for any number of lab-testing purposes that are still currently being accomplished utilizing animals. For instance, three previous OECD test guideline validations for other MatTek in vitro tissue models involve testing for skin irritation, skin corrosion, and eye irritation.

In the same press release quoted from above, Alex Armento, MatTek’s president, noted, “Human tissue replacement models are undoubtedly a better indicator of toxicity and efficacy than dogs or mice, which share very little physiology to humans.” According to researchers, the proposed legislation in the United States would potentially save the lives of millions of animals every year.

Activists, companies in the relevant industries, and researchers have argued for the replacement of animal testing with computer imaging models for decades. However, it’s perhaps only in recent years that these models have become both advanced enough and sufficiently commonplace, industry-wide, for the movement to drastically limit animal testing to succeed. Earlier this year, similar resolutions to the one currently being considered by the U.S. Congress were adopted by both Mexico and the European Union.

Of course, as much of an ethical improvement as the legislation might be over the status quo, it’s important to remember that corporations are concerned with market-share, not altruism, so passing this legislation is in BICO’s interest more from a revenue standpoint than from any concerns it might have with benevolence. This isn’t to say that there’s anything untoward or disingenuous about BICO’s support of the legislation. It’s merely meant to highlight how much of an effort companies driving Industrial Revolution 4.0 will have to make — if they want to be successful in the long-term — in setting up new regulatory regimes to overthrow the old ones. This is not a novel concept, of course: Gabriel Kolko’s classic 1964 history of the Progressive Era, The Triumph of Conservatism, argued that the original federal regulatory regime in the United States was more or less entirely a movement initiated by Big Business for its own benefit.

Images courtesy of BICO and MatTek

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