The gene therapy is said to provides instructions for how to synthesise an anti-ageing protein, but it doesn’t integrate into a person’s genomeAndrew Brookes/Image Source/Getty Images

An injectable gene therapy that promises to make people live longer will soon become available in certain nations. This is despite the fact that it hasn’t been tested in rigorous clinical trials and doesn’t have approval from the US Food and Drug Administration (FDA) or other major regulators.

The gene therapy, developed by Minicircle – a company headquartered in Austin, Texas – is designed to make cells produce more of an anti-ageing protein called klotho. To get around the extensive clinical testing required by the FDA to approve a therapeutic product in the US, Minicircle will offer the largely untested gene therapy to those willing to travel to Honduras, the Bahamas or Panama. The company has opened a waitlist on its website and says it will make the treatment available in the next six months.

Medical ethicists warn that it is reckless to sidestep regulations put in place to protect people from potentially dangerous or useless therapies. “This is the ‘move fast and break things’ mentality of Silicon Valley encroaching on medicine, but the risk is that moving fast with drug development may break people,” says Christopher Rudge at the University of Sydney, Australia.