Silicon Valley Wants to Optimize Your Baby. The Science Is Not Ready

The very force that has put a fitness tracker on the wrist of everyone in Silicon Valley has now made its way to the embryo. Some startups are in the business of rating the embryos from an IVF cycle according to their genetic predisposition for heart disease, diabetes and Alzheimer's, and in some cases height and intelligence, so parents can decide which one to implant. The price tag can run to $50,000 in addition to the cost of the IVF. While one Coinbase founder has put a name to the broader vision, the two U.S. medical societies with oversight of genetics and fertility medicine hold that the science is not ready. In the Valley there is a division of opinion over whether optimizing a baby should be a product category at all.

From Screening for Disease to Scoring for Everything

Embryos have been put through genetic testing for some time. IVF clinics have for years made preimplantation genetic testing available to screen for chromosomal defects like Down syndrome or single gene disorders in the case of Huntington's disease and cystic fibrosis, where a variant gives one high confidence as to whether an embryo is affected. The novelty is PGT-P, or preimplantation genetic testing for polygenic risk, a technique that attempts to gauge an embryo's odds of developing conditions that are the product of hundreds of genes.

It is a wholly different type of prediction. Things like heart disease, type 2 diabetes and most cancers are subject to many minor genetic inputs as well as diet, environment and chance. A polygenic score will not tell you if an embryo is going to fall ill; it indicates the embryo is placed somewhat higher or lower on a curve of projected risk. A few companies take the approach a step further and use it on traits with no disease component, from height and eye color to cognitive ability. There the science is at its thinnest and the ethical questions are at their loudest.

The Companies Selling the Full Picture

Three names are the ones that surface most frequently. There is Orchid of Palo Alto, which sequences nearly the whole of an embryo's genome and confines its reporting to health matters; on its site it has put forward a pledge to "Screen embryos for 1,700+ genetic conditions before pregnancy." Nucleus Genomics in New York offers Nucleus Embryo, a piece of software that can run up to 20 embryos through more than 900 hereditary conditions and a host of other analyses for cancers, chronic ailments, looks, mental and cognitive health. The company touts a $9,999 package and claims the product "empowers couples to make thoughtful choices about their future baby." Then there is Herasight, operating out of a lab in Morrisville, North Carolina, whose screening covers not only health risks but also IQ, longevity, body mass and height.

Costs vary by firm and by the number of embryos tested, yet a complete workup may run as high as $50,000, on top of the $20,000 or so per IVF cycle. Fertility doctors are increasingly willing to order the tests despite the advice of their professional organizations.

What the Medical Societies Say

In a paper for its journal Genetics in Medicine, the American College of Medical Genetics and Genomics put forward its findings on PGT-P. "We determined that at this time there is insufficient evidence of clinical utility of PGT-P," wrote Theresa A. Grebe, lead author of the statement, in an announcement from the College. Susan Klugman, then president of the College, was more direct in the same release: "At this time, PGT-P is not recommended for clinical use, as ongoing research and societal guidelines are needed." The American Society for Reproductive Medicine is of like mind, holding that polygenic risk scores are not yet up to the task of giving reliable estimates for embryos.

The objections are technical as much as moral. For one thing, the polygenic scores are derived from studies of adults, predominantly of European ancestry, and they do not work as well for others. Siblings from the same IVF cycle have too much DNA in common for their score differentials to be anything but small and noisy. Because genes are multi-taskers, choosing for one characteristic can inadvertently choose for another.

The Gattaca Stack

The talk in Silicon Valley has gone beyond screening. Brian Armstrong, chief executive of Coinbase, has put a name to a quartet of technologies he calls the Gattaca stack, in reference to the 1997 movie. The bundle is made up of in vitro gametogenesis to convert a run of the mill skin cell into eggs and sperm, polygenic embryo testing, embryo editing and artificial wombs. A website devoted to the concept puts "The Industrial Revolution for human reproduction" as its tagline and has 30 plus companies and labs on file for their work on one part or another. Armstrong himself wrote on X that "the time is right for the defining company in the US to be built in this area."

Most of the stack is illegal at present. The United States and the majority of other countries have rules against editing a human embryo and carrying it to term since one cannot be sure the edits are safe until the child is grown. Skin cells can be made into eggs in mice but not in humans. Screening is what is available now, which is why PGT-P is the front line; it is the only element of the stack a firm can put on the market this year.

The Sales Pitch and the Precedent

Startups have history on their side when they respond to critics. IVF was once denounced as unnatural, yet it has fathered millions of children in the intervening years. What was a point of contention with prenatal screening for Down syndrome is now routine practice. The companies also contend that their clientele are looking to steer clear of disease, not put together a superior child. Nucleus made its case for an embryo product with the tag "Before there's a heartbeat, there's DNA," a line that resonates with parents who have seen a relative succumb to an ailment a test could have put on notice.

The critics retort that such precedents are a double edged sword. Parents of a child with Down syndrome have called the now common screening for the condition a way of weeding out people like their offspring. To take that same reasoning and apply it to heart disease, height or intelligence is to shift the boundary by increments with no one to call time on it. Eugenics is the word that looms over the whole affair. As for the startups, their chief defense is that the state is not doing the choosing; it is the customer making a free choice for their own family.

What Happens When Fertility Becomes a Software Market?

What is in store for the near future is less a nation of designer babies than a two tiered fertility system that will make its way in quietly. IVF is already beyond the means of most American families to put down out of pocket; tacking on a five figure screening package ensures those with the wherewithal to optimize are the ones who have the most to begin with. Should the scores prove even of some modest use against disease, the divide will be evident where genetics is meant to be impartial: in who is born in better health.

The real danger is the paucity of regulation. Polygenic embryo tests are laboratory developed and the Food and Drug Administration has had trouble keeping tabs on them. There is no federal rule to make a company demonstrate that an embryo score is any kind of predictor before it is put on sale. The onus is left to the patient to make an irreversible decision between embryos on the back of a probability he or she may not be in a position to read, and usually in a clinic with a financial interest in the test. It is only a matter of time until a family sues over a high scoring embryo that goes on to develop the very disease it was chosen to preclude and puts the industry in uncharted legal waters.

Then there is the geography of the dispute. The companies are of American origin, the money behind the Gattaca stack is in the hands of a few in New York and the Bay Area and the most vocal proponent is a cryptocurrency exchange operator. Those in the Valley counter that reproduction has ever been at the mercy of resources and that transparency and engineering are superior to inheritance and luck. One point of common ground is that when in vitro gametogenesis allows a couple to put forward hundreds of embryos as opposed to a few, screening will be the default and not a specialty.

Silicon Valley will have three indications as to how this plays out. For one, the data from an independent study of some size to see if children picked by polygenic score have fewer of the diseases in question, though that will be years off. Two, the law: does a state or the federal government step in to demand validation of an embryo score or is it the first company to put forth unsupported claims that forces the issue? And three, the technology itself. A lab putting out viable human eggs from skin cells or a sanctioned trial of embryo editing for a fatal condition would swell the screening market in a day and the ethics debate would be put to work to keep up.

Healthspan Starts Before Birth

Sparknify has been in step with the Valley's increasing view of the body as an engineering problem. In Why Longevity May Become Silicon Valley's Most Human Moonshot, for instance, it put forth the case that healthspan, or the years of one's independence and good health, is the proper way to judge the longevity movement, and that hype and unequal access are what will most likely do it in. Embryo screening is the same sort of thing, only at life's other end. The promise is the same: fewer years ceded to disease. So are the risks: a science yet to come of age, a cost prohibitive to all but some, and marketing in excess of evidence.

The distinction is that one can discontinue a longevity treatment if it does not deliver; an embryo cannot be unchosen. The question is not if a baby can be optimized but whether those making the sale can prove the optimization is genuine and who is excluded in the process.

Silicon Valley has made a habit of measuring nearly everything. With the embryo it will see what such measurement is worth.

Subscribe to Sparknify for Silicon Valley tech news and the people behind it.