FDA Ruling Could Boost Texas Biotech Firm
At a Texas ranch run by a biotechnology company, a dozen brown-and-white longhorn calves frolic in a fenced-off plot dotted with yellow wildflowers. The playful 2-week-old babies nudge one another and run together. If the calves seem unusually close, it's because they are. All clones of one show champion longhorn, they share the exact same DNA but were borne by 12 different surrogate cows.
With a preliminary Food and Drug Administration ruling last week that it's safe to consume the meat or milk of cattle, pig, and goat clones, Austin-based ViaGen's three ranches could become home to many more cloned calves. Since 2003, at the FDA's request, ViaGen has voluntarily held off on selling clones to breeders anxious to duplicate their prized livestock. But with the FDA's finding that "meat and milk from clones and their offspring are as safe as food we eat every day," companies like ViaGen will have cleared the first hurdle in making cloning technology more common among livestock farmers.
Cloned meat won't be on shelves soon
Supermarket shoppers won't find cloned meat in refrigerated bins anytime soon. First, companies will have to wait for a 90-day FDA public comment period to pass before proceeding further. And with many breeders cautious and consumers wary, even the final report won't immediately open the floodgates to commercial clones.
ViaGen, which sells cloned cows, pigs, and horses, is one of a handful of cloning companies that have survived the wait for the technology to become commercially viable. Because it got started early with a license from Scotland's Roslin Institute, known for cloning Dolly the sheep in 1996, ViaGen is the company with the most riding on final FDA approval, says Val Giddings, president of biotech consulting firm PrometheusAB.
Two other cloning firms aren't as far along: Livestock cloning is a small piece of the business of Trans Ova Genetics, based in Sioux Center, Iowa; Cyagra of Elizabethtown, Pa., clones only cattle and has been limited by the need to raise outside funds from venture capitalists.
Privately held ViaGen, started in 2001 and backed by billionaire investor John Sperling, hasn't had the money troubles that have plagued rivals. The octogenarian Sperling founded the for-profit University of Phoenix in 1976, now part of the publicly traded Apollo Group. For almost 10 years, he has doled out money to back a number of projects, including a failed attempt to clone his dog Missy. Her picture now hangs in ViaGen's office as inspiration.
Side businesses
ViaGen has kept money trickling in by developing side businesses. It clones show animals such as horses at the cost of about $150,000 or competition cattle at $15,000 a head. ViaGen cloned 67 animals in 2006, says President Mark Walton.
ViaGen also developed AnguSure, a genetic test for Angus beef, and stores the DNA of nonprimate mammals, including cats and dogs. That business picked up after the Sperling-backed San Francisco pet-cloning company, Genetic Savings & Clone, closed last year. ViaGen had doubled its capacity in 2003 by acquiring competitor ProLinia. In 2006, ViaGen's sales hit $2.2 million, according to Dun & Bradstreet. Walton estimates, though, that ViaGen won't start making a profit for three more years.
To get in the black, ViaGen must figure out how to lower the cost of cloning, make it affordable to cow and pig farmers, and gear up for the demand that may follow. "The good news is that this won't happen overnight," says Walton. He compares mass cloning to manufacturing. "From the first time someone develops a prototype, it's a long ways before they produce it at scale," he says. Walton expects to clone about 200 animals in 2007 and up to 800 the following year. Before that happens, ViaGen has work to do. It plans to add 16 people to its staff of 40 in 2007.
A hit-or-miss process
The first step for breeders who want to buy clones is to purchase ViaGen's $1,500 biopsy kit, which enables them to collect cells from the tissue of animals they want to duplicate. Cells are stored in vats of liquid nitrogen until a breeder decides to clone an animal. Then ViaGen replaces the genetic material of a harvested egg with that of the animal to be cloned, using a device whose controls resemble video-game joysticks. It takes a few hours to screen 600 eggs to find ones that will work. From that batch, maybe 50 end up as embryos.
A couple of days later, if the transfer takes, the embryo is implanted into a prescreened surrogate mother. Cloning is a hit-or-miss process. There is about a 60 percent chance that the DNA will take to the egg and then about a 30 percent chance that the egg will become an embryo, says Irina Polejaeva, ViaGen's chief scientific officer. Improving those odds is a key to lowering costs.
While the high-tech process takes place at ViaGen's tiny lab in an Austin office park, embryos packed in a cooler are shuttled by pickup truck to a more bucolic locale. The implants take place at one of the company's Texas ranches. Once a heifer gets pregnant, it behaves just like any other animal that is expecting, says animal resource supervisor Nanci Williams.
She has been watching over the 12 longhorn calves at ViaGen's ranch in Bucholz, Texas, while they nurse and notes that the group is friskier than others she has seen. "It's like KinderCare out there," she says. "But they are just cows being cows." After two more weeks at the ranch, the calves go to their owner, who breeds the animals for longhorn showcases.
Once FDA approval is complete, commercial livestock farmers will gradually get into the game to duplicate their fattest pigs and best cows, says Barbara Glenn, managing director of animal biotechnology at the Biotechnology Industry Organization. Because of the technique's cost, only a handful of farmers can afford now to clone their most productive animals. Right now, their genes are spread using other artificial-breeding methods such as embryo transfer. Cloning will improve the process because it increases the chances of producing a top-notch animal. In the end, the offspring of the pricey clones are the ones that will end up producing milk or being slaughtered, Glenn explains.
"At one time, cloning was like a scientific freak show, but now it's just another artificial reproductive technology we can use," says Don Coover, a Kansas veterinarian who raises animals for breeders and heads a firm that distributes bull semen. "There's no question this is technology whose time has come."
Consumers' doubts about cloning
Convincing breeders to get onboard with cloning is one thing. Persuading consumers is an entirely different beast. Even the term cloning "sounds freaky and crazy, like animals are jumping out of an incubator," says Polejaeva. Most consumers initially have negative reactions when asked about cloning, even though it turns out they don't know much about the process and its potential impact on the food supply, according to a Food Policy Institute survey of 17 opinion polls on the topic. With consumer opinion on cloning still mixed, the FDA assessment is crucial in allaying fears about the process, the institute says.
The FDA ruling won't change the minds of cloning opponents. The Center for Food Safety had already filed a petition with the FDA in October to halt cloning, saying it boosts deformities in animals and is a form of cruelty. It also questions the FDA's assertion that there's no need to label food to show that it comes from cloned offspring.
Walton says ViaGen will spend the next couple of years trying to convince consumers and breeders that cloning is safe. "I'd be kidding you if I said that [breeders] were lined up at the door," he says. "That's the nature of a new business. There are far more questions than answers."