A small Wisconsin software startup is gearing up to take on IT giants like IBM and HP in the emerging clinical genomics data-management market.
PointOne Systems, a clinical bioinformatics firm founded in 2000, claims that it’s seeing steady adoption of a software system designed to integrate genetic data from patients along with their personal and family health histories and results from clinical tests to predict their risk of contracting certain diseases.
Last month, the 20-person firm kicked its marketing strategy into high gear by luring company founder Peter Tonellato from his post as director of the Bioinformatics Research Center at the Medical College of Wisconsin to serve full-time as vice president of business development and CSO.
This move followed on the appointment of biotech veteran Frank Langley as CEO in August. PointOne’s founding CEO, Drew Palin, led the company through its first three years as it fine-tuned its product development and raised some initial angel financing, “and he had good experience launching companies,” Tonellato said. “But we realized that with the growth we’re having that we need to tighten up how we conduct our business, so we brought in an experienced business individual.”
Last week, the company solidified a two-year partnership with Aurora Health Care — a network of 14 hospitals and 100 clinics in Eastern Wisconsin — to create a web-based tool that allows Aurora’s 2 million-plus members to document their family and personal health history online. The deal builds upon an earlier arrangement that PointOne signed with Aurora in 2002 to deploy its family and personal health history documentation software within hospitals.
Tonellato said that PointOne initially deployed a breast cancer software module throughout Aurora’s women’s healthcare facilities, and that the company is now in the process of deploying a congestive heart failure module. He said that “a number of hospitals” in addition to Aurora are using the software, and that the company estimates that there are around 5,000 hospitals in the US that have the IT sophistication to implement the system.
PointOne’s software“grabs the data that’s available electronically from the hospital, does a risk assessment for various diseases, and then sends an assessment report to the physician that says this individual appears to have clinical indicators” for breast cancer, congestive heart failure, or other diseases, Tonellato explained. This step, which Tonellato described as the “risk assessment stratification step,” helps physicians decide whether a patient would benefit from a genetic or molecular-marker test.
If the patient does opt for the test, Tonellato said the company offers an additional set of software products for “chronic monitoring” of the patient “to provide more preventive-like treatment, rather than just waiting for the symptoms to get worse and worse.”
Tonellato declined to provide details of the types of information that PointOne’s software uses to determine a patient’s disease risk, citing IP concerns. Secondly, he added, “it depends on which disease we’re talking about.” He said that the company intends to focus its resources on disease areas where “emerging and new and validated genetic and molecular tests have come out,” which have not yet worked their way into common medical practice.
“If you look at all the biotech companies — whether it’s Third Wave, Roche Diagnostics, Myriad — they all have tests, not just in the pipeline, but that have been approved by the FDA as a diagnostic marker, and yet they have not gained wide recognition or use in the healthcare industry because of that huge lag time” — which he pegged at an average of seven years — “between the approval of a diagnostic test to be used as such in the healthcare industry, and its common usage in the healthcare industry.”
PointOne is positioning itself for a future in which there will be multiple genetic or molecular-market diagnostics available for particular diseases, Tonellato said. “There’s just going to be a wide spectrum of which data is most appropriate for which disease, and which genetic and molecular-level markers and tests are going to be most valuable for which disease. And that’s what we’ve built into our system, is the ability to adapt to the more definitive tests as they evolve,” he said. “It’s not likely that one genetic test will replace another test. It’s more likely that one genetic test will be more valuable to a segment of the population, whereas a different genetic test will be more valuable to a different segment of the population. And how you define that segment is going to be dynamic, too.”
Tonellato acknowledged that there is still only a limited amount of information available to provide such assessments, however. “We don’t know the specificity today,” he said. “We have to use the system, and use genetics, and use molecular markers … in order to further validate and segment the understanding of what’s going to be most valuable to whom.”
There are other challenges. Tonellato said that when the company first began using its system in hospital settings, it didn’t account for the “tight workflow” of the healthcare system. Initial installations, in which physicians guided patients through the family history questionnaire, “didn’t work out at all,” Tonellato said. Now, patients can enter this information via the kiosks that PointOne has set up in hospital waiting areas, or via paper forms that are scanned into the system, or, most recently, through the online version.
“The adoption is primarily a function of how seamlessly we can integrate our system’s results — the integrated data in the context of the likelihood of disease — into the usual patient-physician interactions; and we’ve learned a lot,” Tonellato said. He added that PointOne’s molecular diagnostics partners “see that if they want their products to be effective in the healthcare field, they need a system that will effectively integrate this new data and information in the context of the traditional way of doing things.”
But PointOne isn’t the only IT player eyeing this space. IBM is aggressively targeting the market, and recently launched a clinical genomics middleware solution tailored for research groups and hospital systems. HP is also developing a clinical genomics IT infrastructure for the Partners HealthCare system in the Boston area [BioInform 10-06-03], and a number of other smaller players, like First Genetic Trust, Ardais, and Genomics Collaborative (recently acquired by SeraCare) are also marketing informatics systems that integrate clinical information with genetic data.
But Tonellato said he’s confident that PointOne can remain competitive, particularly following Langley’s appointment as CEO. Since August, the company has refined its marketing strategy, he said, “from more of a general perspective of, ‘Here is software that will introduce at a practical level genetic and molecular-level information into your system,’ to a very precise specification and definition about how this product suite integrates breast cancer information and genetic tests in a very practical and specific way for each physician and each patient.”
And, he added, the potential market for such a software platform is limited only by the size of the US healthcare system. “There is not a group that we’ve talked to that hasn’t said we’ve got to move in this direction as healthcare providers; we can’t ignore the results of the human genome,” he said.