Tuesday, December 3, 2013

The Cost of Sequencing a Person’s Entire Genome Has Fallen to Less Than $5,000, from $95m in 2001

The magic of free markets free market technology advancements and falling prices is truly awesome. Yet, the Fed wants "stable' prices. Should we go back to $95 million for gene sequencing? And the FDA is messing with the genetic-testing firm 23aMe. It really makes you hate government.

Economist magazine explains the harassment:
THE Food and Drug Administration had been kept waiting long enough. On November 22nd the FDA, America’s public-health regulator, sent a stern letter to 23andMe, a genetic-testing firm. Despite “more than 14 face-to-face and teleconference meetings, hundreds of e-mail exchanges and dozens of written communications”, the FDA complained, the company had not met its requests for data—nor even contacted it since May. The FDA ordered 23andMe to stop selling its testing service forthwith. The company has 15 days to respond to the regulator’s concerns. Fights over genetic testing, however, are sure to go on for a lot longer.

It used to be that patients learned about their health only from their doctor. Thanks to mobile health gadgets, apps and services such as 23andMe’s, that is changing. Since 2007, 23andMe has invited its customers to spit into a tube, send it back to the company and thus learn the secrets of their genome—or, at least, the aspects of it that 23andMe tests. The company is a Silicon Valley favourite, led by Ann Wojcicki, wife of Sergey Brin, one of Google’s founders. Its backers include Google and Yuri Milner, a billionaire investor in Facebook and Twitter.

Ms Wojcicki maintains that people have a right to their genetic information. The FDA is more cautious. It says that telling people about their genome is all well and good, but because 23andMe’s tests might be used to make medical decisions, the agency must verify their accuracy. In its letter to the company, the FDA said that inaccurate information about a gene linked to breast cancer could lead a woman to have unnecessary surgery.

The company applied for FDA approval last year. Regulators asked for more information, but the agency says 23andMe did little to gather it. Meanwhile, the company pressed on with other plans. In the past year the firm has lowered the price of its tests to $99 and hired Andy Page, a former president of Gilt Groupe, a shopping website, as its own president. With the goal of testing 1m people, 23andMe launched a national television campaign in August. But seeing little sign of progress with its application, the FDA has called a halt.

It is unclear how the dispute between the FDA and 23andMe will be resolved. In a blog post on November 26th Ms Wojcicki defended the quality of her company’s products but admitted that it was “behind schedule” in its response to the FDA. More rules on gene tests of all sorts are on the way. The cost of sequencing a person’s entire genome has fallen to less than $5,000, from $95m in 2001, according to the National Institutes of Health, America’s medical-research agency. The FDA says it is trying to push things along: on November 19th it approved the first “next-generation” sequencer, made by Illumina, a company from San Diego. Doctors will be able to search patients’ whole genomes to help guide treatment.

Though the FDA talks up progress, there is a risk that it may slow it down. The agency is weighing regulations on test kits sold directly to consumers, laboratory tests and software that analyses raw genetic data. It is clear that 23andMe is not the only testing firm in its sights.


  1. "...the FDA said that inaccurate information about a gene linked to breast cancer could lead a woman to have unnecessary surgery."

    Of course, keeping the information from her at gun point could kill her, not to mention that if she violates the FDA mandates, she could have her freedom or her life forcibly removed; that never enters the picture.

    And the lambs will applaud their slaughterers.

  2. Only a fool would make dramatic health decisions based ONLY on a $99 test. But, a $99 test that indicated predisposition towards breast cancer, or diverticulitis or any other of hundreds of possibly preventable health issues would ENCOURAGE them to change their diet, or seek medical care.

    The FDA is just trying to protect the medical cartel.

  3. It was $5000 two years ago. If it's still $5000 then there's been no progress since then.

    1. And if that were the case, what's your point? It was $95M in 2001.

  4. Obamacare and Stalinism
    By Peter Morici

    Eventually project overseer Jeffrey Zients will have this monster fulfilling all its functions, but likely it will be a balky, frustrating website, much like other federal websites or those run by private firms enjoying monopoly power.

    Health insurance will be right up there with dealing with tax filing. Bureaucrats will have easy access to sensitive personal data, which Obama administration political moles can use to target, harass and sometimes destroy critics, and simply occupy millions of hours of citizens' time that could be used more productively.

    Welcome to statism - the ants of capitalism herded into a bureaucratic hell to serve the masters of a grander design.

    All this aside, let's look at the list of promises that will remain unkept when the website is fully repaired, no matter how well it may run:
    If you like your insurance, you can keep it;
    If you like your doctor, you can keep him;
    If you need help finding the coverage you need, we will make it easy;
    And by organizing the healthcare market under the guiding hand of the omnipotent state, we will make insurance cheaper.

    The first two promises are forever broken. Insurance companies can't bring back most policies the Affordable Health Care Act declared illegal, a presidential edict notwithstanding. And insurance companies are slashing doctors and hospitals from their networks to meet arbitrary Obamacare mandates.

    Folks who had perfectly adequate policies, which were delivering hundreds of thousands of dollars in life saving benefits from specialized physicians for cancer treatment and other complex illnesses, have lost those benefits and been offered replacement policies cluttered with unneeded services - for example, pediatric vision care for childless couples in their 50s and birth control benefits for nuns.

    Many Americans face death when old policies lapse and can no longer pay for the care they need. But as a Washington lawyer and ardent support of the president assuaged me, some sacrifice is needed by a few for the progress of the many. Echoes of Stalin's casualties building the Moscow subway.

    Overall, premium costs are rocketing for many Americans, not because their old coverage was inadequate or because new coverage is better, but because they are in markets now served by fewer providers and less competition than before. Businesses are forced to jettison full-time positions in favor or part-time workers to avoid paying health benefits they can no longer afford and avoid penalties that will be imposed beginning in 2015.