Nathan R. Treff PhD, Chief Science Officer at Genomic Prediction at the Commercialization Center for Innovative Technologies in North Brunswick. New Jersey, a state built on big pharma, is shifting gears and cheerleading for small pharma. August 14, 2017, North Brunswick, NJ.
Bob Karp/Staff Photographer
NORTH BRUNSWICK –Â Nathan Treff was in graduate school studying biochemistry when he was diagnosed with Type 1 diabetes, a disease that would require constant monitoring to avoid deadly complications.
His career, however, put him on the front-line of cutting edge research that made anything possible, and he began to wonder: What if, instead of treating diabetesÂ day in, day out, you could prevent it in the first place?
What if, he wondered, you could detect the gene associatedÂ with diabetes in a humanÂ embryo and stopÂ it?
Treff’s year-old start-up, GenomicÂ Prediction, is closing in on an answer. It has begun to offerÂ prospective parents at fertility clinics a chanceÂ to test their embryos for diseases such as diabetes, hypertension and breast cancer, so that their children couldÂ live a life without them.
Reproductive medicine experts say it could be revolutionary. Until now, they could only offer tests on embryos for what’s known as single-gene disorders such as cystic fibrosis and Fragile X syndrome. The diseases that Treff is tackling are more complicated and affect as much asÂ a quarter of the population.
But the experts also said society isn’tÂ prepared for the breakthrough. Once you find the cure to those diseases before the baby is born, it isn’t a big leap to a day when clinics can offer parents a chance to choose their babies’ cosmetics as well.Â
Height, eye color, intelligence? TheyÂ could all be on the menu to create a designer baby, Dr. Serena Chen said, raising the prospect that Amazon one day could have a genomics division that willÂ deliverÂ your baby to your home.
“As a society, we have to think about, what is it that we want and what are the implications,” said Chen, director of reproductive medicine at the Institute for Reproductive Medicine and Science in Livingston, New Jersey. “If we are going bigger, taller, faster, stronger, smarter, how does that affect society?”
“As our ability to do these things grows rapidly,” she said, “how as a society are we going to handle this?â€ťÂ
Bhavini Rana, a Field Application Specialist prepares and embryo biopsy kit at the Commercialization Center for Innovative Technologies in North Brunswick. New Jersey, a state built on big pharma, is shifting gears and cheerleading for small pharma. August 14, 2017, North Brunswick, NJ.
Bob Karp/Staff Photographer
Treff, 41, of Bedminster,Â founded GenomicÂ Prediction a little more than a year ago with researchers Stephen Hsu and Laurent Tellier, setting up shop in laboratory space atÂ The Commercialization Center for Innovative Technologies here.
When he was diagnosed with diabetes, Treff was planning a careerÂ inÂ cancer research, hopingÂ to prevent people from dying. But after he had his own children, he thought it might be neat to helpÂ create life, too.
He spent more than a decade as director of molecular biologyÂ at Reproductive Medicine Associates of New Jersey,Â a fertility clinic based in Bernards Township, before he joined Hsu and Tellier to launch their startup.
The scientists’ discoveryÂ is turning heads.Â
What sets it apart? They not only canÂ test for diseases that affect one gene, but also they haveÂ an algorithm that canÂ test for the risk of diseases found in thousands of positions on the human genome.Â
In short, they can look at a human embryo and see if it is at risk for type 1 and type 2 diabetes;Â short stature; hypothyroidism; mental disability; atrial fibrillation; coronary artery disease; inflammatory bowel disease; and breast cancer.
Prospective parents who see an embryo that is more susceptible to those risks can choose a different embryo to be implanted.Â
New Jersey regulators gave the company approval in July to sell the product in the Garden State. The cost: $400 per embryo, which typically isn’t covered by insurance.
“If we want to think about it long term, weâ€™re hoping we can actually reduce the incidence of disease in humans,” Treff said. “What weâ€™re doing is helping people have healthy pregnancy andÂ avoiding miscarriage, which can be a pretty significant trauma for someone to go through, especially people who want to have kids.”
“Itâ€™s giving the patients an extra tool for selectionÂ for what may be more likely to be a healthy child,â€ť he said.
Reproductive endocrinologist Dr. William Ziegler discusses both ethical and unethical uses of invitro fertilization. Couples can choose what eye color their child can have as well as prevent diseases such as diabetes and breast cancer in an embryonic level. Wednesday, October 3rd, 2018, in Toms River, New Jersey.
It’s been 40 years since Louise Brown was born, becoming the world’s first “test tube” baby, even though no test tubes were used. It openedÂ the doors to what was possible for Â couplesÂ who were having difficulty getting pregnant.Â
Among them are women over age 35. About half the eggs they produce have the wrong number of chromosomes, which often results in miscarriage, Treff said.
They could go through in-vitro fertilization, in which mature eggs are retrieved from a woman, fertilized by sperm in a lab and then implanted in the woman’s uterusÂ â€” a process called a cycle.
In 2016, there were at least 463 fertility clinics in the United States, which used assisted reproductive technology that resulted in nearly 71,296Â babies born, or 1.7 percent of all infants nationwide. That’s was up about more than 5 percent from the previous year, according to data from the American Society of Reproductive Medicine, a trade group.
It can be expensive, costing more than $10,000, and some hopeful couples need to go through it more than once for a successful pregnancy.
New Jersey is one of 15 states that mandate insurers provide fertility coverage. But insurers need to be based in the state, andÂ religious organizations can be exempt.
Tests like the ones GenomicÂ Prediction provideÂ â€” called pre-implantation genetic diagnosisÂ â€” costÂ extra.
But experts said those testsÂ can lead to a better chance of a successful pregnancy, attracting not only women over 35, but also men and women who are worried that their family history of diseases could be passed to their children.
Dr. William ZieglerÂ of the Reproductive Science Center of New Jersey has officesÂ in Eatontown and Toms River. He has been practicing reproductive endocrinology since 1995.Â And he has seen the field only expand.
Time was, pregnancies were confined to young women who had a male partner.Â Now? Single women, same-sex couples and women later in life have a viable option. Â
The procedure also is catching on in popular culture; after Kim Kardashian publicized her decision to freeze her eggs, Ziegler said his office was inundated with phone calls from women hoping to do the same.
GenomicÂ Prediction’s test caught his interest, he said.
He said the chance to test embryos for potential diseases was revolutionary. But he still wanted more assurances about its accuracy.
“You have to realize that an infertile couple isÂ looking for any solution,” he said. “Theyâ€™re looking for the golden ring, and they will go anywhere to find it. They need to trust their doctor to give them the correct information for their infertility condition.”Â Â
Kimberly Mutcherson, vice dean and professor of law at Rutgers Law School in Camden.
Courtesy of Kimberly Mutcherson
GenomicÂ Prediction leavesÂ the fertility industry with an ethical dilemma hanging on its shoulders.Â
The same technology it uses to find diseases also can be used to predict a child’s physical characteristics.
One scenarioÂ perhaps not too far away: Parents get a readout of an embryo and they can either discard it orÂ fix what they don’t like by editing the gene.Â Â
Did you want a boy with blue eyes, lustrous hair andÂ a lower risk of getting diabetes? Here you go â€” if you can afford it.
The advances have prompted calls for tighter regulations to protect consumers from unscrupulous operators more interested in the bottom line than the patients’ well-being.
While GenomicÂ Prediction received approval from the New Jersey Department of Health and the Centers for Medicare and Medicaid to operate as a laboratory, it didn’t need approval from the U.S. Food and Drug Administration, which oversees drugs, devices and donor tissues, but not tests.
And it puts more pressure on clinics to better educate and counsel their patients, said Kimberly M. Mutcherson, vice dean and professor of law at Rutgers Law School inÂ Camden.
“Once you do these kinds of things, you literally are having impact on what kind of people get created and what kind of people exist in the world,” MutchersonÂ said.Â
“Itâ€™s very easy to say, ‘Oh, I can understand why someone wouldnâ€™t want a child, for instance, who has Tay-SachsÂ disease, who’sÂ goingÂ to live a very short and painful life. That would be really awful.’ So, given the choice, lots of people wouldnâ€™t want to do that.
“Is that the same as someone who has diabetes, where someone can live very long, happy and healthy lives, even though they are diabetic?” Mutcherson continued. “So, what kinds of diseases do we think are significantÂ enoughÂ that thereâ€™s a reason why a person shouldnâ€™t exist?
“I think there are really deep philosophical and ethical discussions about creatingÂ standards for babies,” she said. “What kinds of babies are worth having and what kinds of babies are not worth having?Â And I think that should make all of us nervous.”
Treff said his company has received inquiries about whether it tests for cosmetic traits. HisÂ response: No, it is only interested in preventing disease.
“People are concerned about the technology being used for non-medical reasons,” he said. “I think itâ€™s a legitimate concern. We just need to make sure there are checks and balances in place to prevent using the technology in the wrong way.”
Embryos that go through GenomicÂ Prediction’s test wouldn’t beÂ immunized from everything. They eventually could be at risk from environmental factors like smoking and an unhealthy diet.
But Treff thinks his company is on the forefront of a new age, and he’s excited by its prospects.
For now, the company is offering hopeful couples the chance to choose an embryo with the best chance to live a healthy life. It hopes one day to take the next step: simply edit the genome to reduce the risk of disease.
If his own parents had that option, “they could have potentially edited out my diabetes and it would have been a cure,” he said. “I would have been here without diabetes.”Â
Follow Michael L. Diamond on Twitter:Â @mdiamondappâ€‹â€‹â€‹â€‹â€‹â€‹â€‹
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