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Cathy Tie slips on a white lab coat bearing her name and the logo of her startup: Origin Genomics. "Welcome!" she says as she leads an NPR reporter, photographer and videographer on an exclusive tour of Origin's labs located in New York City. Tie, CEO of Origin, asked NPR to withhold the exact location for security reasons.
"We'll head into the lab," she says.
Once inside, Tie snaps on a pair of blue rubber gloves and points to a gray metal tank on the floor that looks like a giant thermos.
"This is a cryogenic storage unit that has liquid nitrogen inside, which is where our embryos are stored," she says.
Tie twists open the black lid, letting wisps of white fog from the liquid nitrogen swirl out from the tank. Tie gently slides out a long metal rod cradling frosted glass tubes at the end.
"So as you can see, there's four tubes in here," Tie says. "Each tube can contain up to 10 embryos."
These embryos were donated by couples whose families have been plagued for generations by life-threatening genetic disorders. Later, a wife and husband who donated some of those embryos tell us about their dream of having healthy children with the help of gene editing.
But first, Tie explains how Origin's scientists extract stem cells from the embryos to test the company's experimental gene editors to see which of the molecular tools might safely correct the genetic defects, preventing future generations from suffering the same fate.
Using gene-edited embryos to create babies is against U.S. law
Tie wants to convince the world that the benefits of using her company's advanced gene-editing technology to fight inherited diseases outweigh its risks.
Editing genes in human embryos that would be passed down for generations has long been taboo because of ethical and safety concerns. In the U.S., it's illegal.
She says it may be time to reconsider.
"Hundreds of millions of people around the world have these diseases: Huntington's, cystic fibrosis, hereditary cancers, Tay-Sachs," says Tie.
"What we are proposing is something completely revolutionary: Apply this amazing precision genome editing to embryos that have a mutation before they are born," Tie says. "That allows the next generation to not be born with these diseases. It changes the entire paradigm of medicine as we know it."
Origin is also testing gene editors designed with the help of artificial intelligence on other kinds of cells carrying disease-causing mutations. Those cells include induced pluripotent stem cells, which scientists create in the lab from adult skin or blood cells, and other cells called fibroblasts.
Tie leads us into another room to show us that work, including cells carrying a mutation for breast cancer that Origin is trying to repair.
She gingerly lifts a clear plastic tray from an incubator and places it under a microscope that projects images of the cells onto a monitor.
"What you see here is the gene editor actually going into the cells," she says.
The cells look like fluorescent green blobs. Those glowing a lighter-color green indicate the gene editor has successfully made it into the cell, she says.
"What this means is now we have a really great platform to introduce our proprietary gene editors into those cells to then correct the mutation," Tie says. "You're looking at the very first step."
Concerns about risks and ethics hang over the field
Indeed, it's still very early days for Origin, and at least one other U.S. startup is doing this sort of thing, Preventive in San Francisco. But the very existence of these companies is striking, given the thicket of issues raised by the prospect of creating gene-edited babies, and the controversial history of the field.
He Jiankui, a Chinese scientist, was imprisoned for three years after he stunned the world by announcing in 2018 that he had used CRISPR gene editing to create the first genetically modified babies.
At that time, the technology was considered far too new for anyone to know if it was safe for the babies — or future generations. The gene editing could have inadvertently created dangerous mutations that could then be passed down for generations.
Most scientists think it's still premature to try to use genetically modified human embryos to produce babies — and it may never be safe. But newer, more precise gene-editing techniques, such as prime editing and base editing, have improved the accuracy of the technology.
Some scientists and bioethicists argue that the advances raise hope that they might one day be ethical to use gene editing to prevent some devastating genetic diseases.
But already Silicon Valley venture capitalists, East Coast entrepreneurs and others have emerged to try to push the field forward.
Still, even among those people who think modified human embryos may someday be safe enough to be used in very limited circumstances to prevent rare diseases, some worry about Origin Genomics.
"It's giving people false hope," says Robin Lovell-Badge, a biologist at the Francis Crick Institute in London. "And I am concerned that they are rushing ahead too fast and making some mistake, which would then set back the field — and the hope that people may have these techniques may eventually help them will be lost."
Would gene editing be used for designer babies?
Even if editing of human embryos could be proven to be safe, some fear that allowing it at all could open the door to designer babies and a dystopian future of genetically enhanced people.
"I'm very concerned about where this could be headed," says Katie Hasson, who runs the Center for Genetics and Society, a watchdog group. "Some of the Silicon Valley investors behind these firms are very open about their vision for the future. It's a vision of mass-produced, genetically engineered humans that's horrifying."
Other companies are already screening embryos for traits like IQ and height in addition to risk for diseases.
The work in the private sector worries some academic researchers. "I just don't think they're being honest with us about why they're really doing this," says Fyodor Urnov, who studies gene editing at the University of California, Berkeley. "They're really in the business of embryo — and thus ultimately baby — improvement."
Tie says that's not the case for Origin, stressing she has no interest in anything except helping people have healthy children.
Some also worry the advent of these companies may lead to unregulated clinics springing up overseas to offer embryo editing where regulations are looser.
"I'm very concerned about genome-editing tourism," says R. Alta Charo, a professor emerita of law and bioethics at the University of Wisconsin-Madison who's now consulting for government agencies and private companies. "This is my fear for what comes next."
Tie's work draws additional scrutiny because she was personally involved with the notorious Chinese scientist after he was released from prison.
But for her part, Tie says the rogue scientist is not involved in Origin in any way. She promises she's moving very slowly and methodically, with independent oversight and transparency to make sure embryo editing would be safe.
"This is a very powerful technology. Safety must come first," she says.
"I think that if you have a technology that can be proven to be safe, and it can help hundreds of millions of people that suffer from these diseases, it is unethical to not pursue this research," Tie says. "My hope is that humanity can capture the upside of this technology."
She hopes Origin will eventually produce enough data to convince Congress to lift a long-standing ban on the Food and Drug Administration even considering experiments involving gene-edited human embryos, as well as persuade regulators in other countries.
"Clinicians, regulators, bioethicists, regulators, patient advocates — all of us must come together to make sure this technology is used in the right way," she says.
A chance to spare children from inherited diseases
Tie suggests NPR meet with one of the families she's working with. So a reporter and photographer travel across town to visit a towering apartment building in midtown Manhattan and take the high-speed elevator to a penthouse to meet Nicole and Asaf Ezra.
Nicole, 38, is originally from the United Kingdom. Asaf, 37, is from Israel. They'd love to have three kids.
"I've always wanted physically my blood and flesh children. I want to have my biological children," Nicole says. "I want it to be a little me or him running around and be like, 'Yep, that's my kid.'"
But the couple's been struggling to have children for years because Nicole comes from a family that's been plagued for generations by a rare but terrible genetic condition known as familial adenomatous polyposis.
A genetic mutation causes precancerous growths called polyps to form in the digestive system. They can become cancerous if they aren't removed.
"When I found out we had it, I was petrified," Nicole says. "It was a slam in the face. It was very hard."
Nicole had to have most of her large intestine removed when she was 13. She regularly undergoes procedures to spot and remove polyps. She lives in fear she'll get colorectal cancer, like her grandfather, her mother, and so many other relatives.
"It's horrible," she says.
So Nicole has gone through rounds of IVF to try to produce embryos that haven't inherited the mutation. The couple did finally get one healthy embryo, but lost that pregnancy to a miscarriage. The couple is still trying.
But Asaf also heard about Origin Genomics.
"We just don't want to pass on cancer to our kids," Asaf says. "Who would want that, right?"
So Nicole, a therapist, and Ezra, who works at a venture capital firm, invested in Origin and donated three of their affected embryos for the company's research.
"The amount of women this would help would be amazing," says Nicole, choking back tears. "I know I'm crying now because I'm thinking about it. But it's really tears of joy for people with the chance that they'll get. It would do so much good for the world, and there's so many women who won't get the trauma that I've had."
When it was first developed, IVF raised similar fears, the couple notes. Society just needs to regulate this technology to make sure it's used for the right reasons, they say.
"We shouldn't give up technology for fear of creating other things," Asaf says. "I don't think that's the moral high ground here."
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