The first few years at NextBio were about serving research customers. Then came Big Pharma and biotech companies.
But now, as genomics has outpaced Moore’s Law in terms of speed and cost improvements, a new type of customer is sniffing around. Physician/scientists are suddenly leaning on NextBio’s software to comb through genomic reports in order to make decisions about personalized medical treatment. Done right, this kind of individualized experiment could build new knowledge for well-controlled studies in the future, and maybe could even help certain terminally ill patients in the here and now.
Cupertino, CA-based NextBio, which has helped scientists analyze DNA data since 2004, has seen this third type of customer emerge in the past few months. Essentially, sequencing of entire human genomes, or gathering other forms of genetic data, has gotten so fast and cheap that physicians at top medical centers, in some cases, are able to incorporate hard-core genetic analysis into last-ditch ideas for treatment. Once the doctor has used a DNA sequencing instrument to generate reams of data on the patient’s genetic profile, they need help merging that dataset with what’s known about other similar patients in the published scientific literature. Theoretically, this layering of information might help a doctor get an idea about how the individual’s tumor might respond to a certain combination of chemotherapy.
NextBio, a cash-flow positive company with 75 employees, already has a long list of academic and industrial customers for its biology software service. Those customers, including Merck, Amgen, and Pfizer, pay hefty annual licensing fees for NextBio software. The main idea is to help them find correlations between data in the public and private domains, says CEO Saeid Akhtari. But this new “translational research” service to physicians on a case-by-case basis, at $2,500 per patient for a single-day turnaround time, has become the fastest-growing revenue segment for NextBio.
By 2015, these individual genetic reports will likely represent a majority of the company’s business, Akhtari says.
“We see a new market emerging, that’s more translational. These are people with one foot in research and one foot in the clinic,” Akhtari says. “The need has always been there, but the cost is now low enough [physicians] can afford to generate the data on individual patients.”
This trend, which Akhtari’s co-founder Ilya Kupershmidt will be able to discuss at Xconomy’s “$1,000 Genome” event in San Francisco on Monday, October 24, raises some very interesting scientific and ethical questions. NextBio, for example, is careful to position this service as just added information for physician/scientists in their research, and emphasizes that it’s not intended to be a diagnostic tool—which would raise questions at the FDA about regulation. Many of the physicians who have started using the reports often need to team up with genetic counselors to help with interpreting the data, and communicating it to patients, to make sure there’s informed consent and no misplaced enthusiasm about where it might lead.
Here’s an example of how the system might work today. A patient with metastatic melanoma, a deadly form of skin cancer, might have a sample of their tumor completely sequenced, or scientists may choose to look at the tumor’s gene expression profile or genetic copy number variations, Akhtari says. This researcher, at a place like Stanford University, might see 200,000 mutations in the patient, 200 of which are considered severe. Based on that individual readout of the patient’s type of cancer, and prior published studies on how patients with similar prognoses performed on various drugs, the doctor could get a new idea for how to treat a patient who has essentially run out of the usual options, Akhtari says.
NextBio has been laying the groundwork for this kind of move for years. As I described in a feature here a year ago, the company’s business takes vast amounts of genomic data piling up in free public databases like those run by the National Institutes of Health and pools it with proprietary internal data from for-profit customers. NextBio aspires to make this web-based service so easy to use that a biologist doesn’t need help from a trained bioinformatics expert, and can get clear answers in real-time on how, say, certain genes are up-regulated or down-regulated in a diseased tissue.
Looking at an individual cancer patient’s tumor profile is one thing, but NextBio has sought to give that information a lot more contextual meaning by matching it up with data from previously published papers. The company’s deal with Elsevier, the academic publishing giant, has made this all much smoother, Akhtari says.
Getting all the data integrated together is no small thing from an engineering standpoint, and neither is the interpretation. NextBio has started hiring physicians on staff, and as consultants, to help serve as the liaisons to some of these physicians looking for help with interpreting these translational research reports, Akhtari says.
Innovation in DNA sequencing instruments has moved ahead so fast that it is now making it possible for scientists to run really ambitious experiments that weren’t possible a year ago, and it’s creating more demand for help with interpretation, Akhtari says. Major genome centers today spend only about 2 percent of their budgets on bioinformatics to manage their data, although that figure is climbing to 10 percent, and could reach as high as 50 percent in the next few years, said Goldman Sachs analyst Isaac Ro, in an Oct. 3 note to clients.
“We believe the field of bioinformatics for genetic analysis will be one of the biggest areas of disruptive innovation in Life Science Tools over the next few years and investors should watch developments in this market carefully,” Ro said.
It’s anybody’s guess how big the market could get for “translational research” studies on individual genomes. Most of the physicians looking for the NextBio reports are getting the work paid for out of their grant money from the National Institutes of Health, not health insurers, Akhtari says. It’s hard to imagine physician/scientists ordering up a $2,500 test, which may or may not provide any useful information, for anything other than people with terminal diseases like cancer. Even then, certain treatment combinations for types of cancer will need to be tested in long-term, controlled clinical trials before these types of reports will be accepted as a standard of care.
People have a right to be skeptical of the genomic data claims. Ro, in his Oct. 3 report, cited one researcher from Cold Spring Harbor Laboratory who said no good commercial genomics software program exists yet. There are still lots of labs out there relying on open-source software offerings, providing cheap alternatives. But Akhtari, who sold his last company to Agilent Technologies in 2004, says he’s so bullish, he’s looking to build an independent company for the long haul.
NextBio is even keeping an eye out for when the IPO market re-opens, he says.
“There are so many companies out there generating different types of data, whether it’s Illumina, Life Technologies, Complete Genomics, or Agilent,” Akhtari says. “My goal is to sit on top of all this, and make it useful, accessible. Our goal is to change the way genomics is used in medicine. It’s going to be huge.”