The year in biotechnology began with a landmark event. A decade after the first human genome was decoded at a cost of about $3 billion, the sequencing-machine company Illumina, of San Diego, introduced a new model, the Hyseq X-10, that can do it for around $1,000 per genome.
The system, which costs $10 million and can decode 20,000 genomes a year, was snapped up by large research labs, startup firms like J. Craig Venter’s Human Longevity (which plans to sequence 40,000 people a year), and even by the British government (the U.K. is the first country with a national genome sequencing project).
Francis de Souza, Illumina’s president, predicted that within two years the genomes of about 1.6 million people will have been sequenced.
Cheap sequencing means a deluge of information and a new role for technology designed to handle and exploit “big data.” The search giant Google was the tech company most attuned to the trend, launching a scientific project to collect biological data about healthy humans, and offering to store any genome on its servers for $25 per year. A coalition of genetics researchers backed by Google tried to introduce technical standards, like those that govern the Web, as a way of organizing an “Internet of DNA” over which researchers might share data.
Easy access to DNA information led to debates over how much consumers should know. The U.S. Food and Drug Administration has said direct-to-consumer genetic health tests aren’t yet ready to be marketed. But consumers found ways to get the data anyway. Thousands of people headed to unregulated corners of the Internet to learn about their genes, and one father even managed to sequence the DNA of his own unborn son, claiming a controversial first.
Easily the hottest technology of the year was a new gene-engineering method called CRISPR, a powerful new “editing” system for DNA. Chinese scientists used it to produce genetically altered monkeys in January, and other scientists are now expected to create monkeys that model human psychiatric diseases. One measure of the technology’s importance is that scientists are now fighting over who really invented it first—and who should own the patent on it.
During the year, bioengineers advanced on all fronts using other technologies. We saw novel kinds of cell therapy used to treat degenerative eye diseases, positive results from a study of gene therapy that could cure HIV, and the resurgence of a form of gene therapy called RNA interference. The development of replacement organs took steps forward, too, including new research showing how to add blood vessels to lab-made tissue using a 3-D printer.
This year, 10 of 35 new drugs approved by the FDA were biological molecules, like antibodies or protein injections. That was a record. And the FDA says the list of new drugs entering testing for the first time is dominated by biological treatments.
Those biotech drugs include the most important medical breakthroughs of the year, a new class of cancer drugs called “immunotherapies.” The drug company Merck has been testing an antibody that helps the immune system recognize melanoma cancer cells—with near miraculous results for some patients. The other approach to immune therapy involves reëngineering a person’s white blood cells to recognize and kill certain kinds of leukemia tumors.
Bioengineering doesn’t stop at DNA. The U.S. BRAIN Initiative, President Obama’s signature science project, has the aim of developing emerging neurotechnologies for measuring the brain and eventually figuring out the neural code. The broad approach of the U.S. project contrasts with that taken in Europe, where funding has been directed toward one mega-project to create computer simulations of the brain, something that drew sharp fire from dissenting neuroscientists.
Bioengineering—whether it’s of the brain, of new drugs, or of our food—could solve some of the planet’s biggest challenges. For example, GMO crops could help us adapt to the unpredictable changes that climate change could bring. Yet many people are not convinced that these ideas are as safe or as useful as technologists promise. In the U.S., some entrepreneurs hope that new technology for editing genes of animals, like dairy cattle, might lead the public to reconsider its opposition to genetically modified animals. In some countries, like China, where fear of GMOs is widespread, governments have chosen to hold back on commercialization. Yet as we reported this year, China continues to plow billions of R&D dollars into creating stockpiles of genetically modified plants.
To scientists, there’s irony to the way things are developing. In Europe, the first Western gene therapy went on sale this year (it treats a rare liver disease by fixing a mutant gene) for $1.4 million a dose—making it the most expensive medicine in history. Yet European countries don’t see a similar value in GMO crops and have essentially banned them.
George Church, a genetic engineer at Harvard Medical School, thinks this presents a technology paradox. He was the source of our favorite quotation of the year: “We have genetically modified human beings walking around in Europe not eating GMO food.”