Ashley notes that there may come a day when a patient’s entire genome could be sequenced at the bedside, which may encourage a different model for bedside genotyping. “But we aren’t there yet,” he says. Genome-sequencing technologies capable of clinical diagnoses currently require days to identify all the base pairs in a human genome. “Sometimes, speed is of the essence,” says Ashley. The technology is a good example of a real opportunity to do actual personalized medicine in real time, he says.
Spartan Bioscience got regulatory approval for the test in the European Union in December 2010, and hopes to have approval in the United States by the end of this year. The company gives away the devices for free, and charges $200 per test.
Spartan Bioscience is also looking for other applications for the technology, says Lem, from infectious diseases like MRSA, an antibiotic resistant strain of staph infections, to pharmacogenetic markers such as a hereditary resistance to standard hepatitis C treatment.
“Doctors from around the world have been pinging us with all the applications they’ve been saving up to the day when a bedside DNA test is finally available,” says Lem.