Cerner, a health IT firm with more than 5,000 employees and nearly $1 billion in annual revenues, has entered the bioinformatics market with the launch of its latest informatics offering.
The technology, called PathNet Helix, was released last week and targets the emerging clinical genomics market. Though big IT players like IBM and HP, as well as a number of smaller bioinformatics startups, have set their sights on this market, Cerner is approaching the technology and the market from a different direction — which may give it an important advantage.
With an installed base of around 1,500 clinical laboratories, Cerner has a strong presence in the target market for clinical genomics tools, and its IT infrastructure is already in place at many of these labs. PathNet Helix plugs into this existing architecture, a three-tier system called Cerner Millennium, making the transition to clinical genomics relatively seamless for its existing customers, according to the company.
The heart of the system is a controlled vocabulary called the Clinical Bioinformatics Ontology, which is a component of Cerner’s broader Controlled Medical Terminology, a key support layer in the company’s Millennium architecture.
“We found that the medical vocabularies lack rich terminology for genomics, so we decided to develop a new vocabulary,” said Mark Hoffman, genomics solution manager at Cerner. Cerner’s ontology differs from other controlled vocabularies in the bioinformatics field, such as the Gene Ontology, “in that our goal is to really structure information that’s generated through diagnostic testing, whereas the Gene Ontology is formatted primarily to describe the classification, in functional terms, of proteins and genes,” he said.
Hoffman said that some “key” features of Cerner’s ontology include cytogenetics-related terminology and “coded values” for clinically significant SNPs.
Because this vocabulary is linked to Cerner’s broader medical terminology, patient data is automatically integrated with genetic information in the system. “All of our various applications populate a single common repository, and you can imagine in the genomics world, that if you can start combining molecular diagnostic information with broader clinical information, that creates a valuable resource,” he said.
Hoffman said that there are several differences between PathNet Helix and clinical genomics solutions from IBM and other vendors. Because Cerner comes from the clinical side of the fence, rather than the genomics side, “our solutions are built to support the clinical environment, and a key difference between that and the research environment is that there are a number of regulatory features that we have to support, including compliance with CLIA, HIPAA, and a number of other regulatory domains.”
Hoffman said that Cerner has had a “number of conversations” with IBM about the Clinical Genomics Solution that Big Blue launched in July, “and they’re not focusing on tools that are used in the delivery of patient care. They’re looking at the downstream analysis, so I think, at least at a high level, that the two efforts are complementary.”
PathNet Helix is very much designed for clinicians, however. Daniel Bellissimo, director of the Molecular Diagnostics Laboratory at the Blood Center of Southeastern Wisconsin, said that his lab finds the system’s “one-screen workup history for each patient” to be particularly useful.
The center is an alpha partner for PathNet Helix, and has been co-developing the system with Cerner for the past nine months.
Julie Bauer, who works in the information services group at the Blood Center’s molecular diagnostic lab, said the ontology, which “links everything back to genetic concepts,” has helped the group handle the large amount of data from genomics-based diagnostic tests. Information is presented in a different way — a grid-based view rather than a linear view — which helps users handle the information, she said.
Cerner’s Hoffman said that PathNet Helix can currently process data from PCR studies, as well as diagnostic sequencing.
“We’re also looking at how we would integrate with microarray devices,” he said, adding that “those aren’t currently utilized in the clinical setting, so we’re at an exploratory phase with that.”
Cerner also has plans to expand its genomics offerings.
“One of our key goals at Cerner is to support patient safety, and we see pharmacogenomics as being an increasingly important aspect of that,” Hoffman said. The company’s software already supports CPOE (computerized physician order entry), and Hoffman said that a logical step would be to integrate a patient’s molecular diagnostic results into that process. “We’re positioned — between the physician and the pharmacy — to evaluate their orders against all known information about the patient. And as you begin to have genomic information about the patient, if an order is placed that’s contra-indicated by the known information about that patient, we can warn the physician that maybe you should reconsider this choice, or maybe you should modify the dosage.”
Hoffman noted that this is still an “emerging” effort at Cerner, but said that the company has already performed some pilot projects in that area.
As for PathNet Helix, the company has signed one undisclosed customer for the offering, and has “a couple others in the works.”
While clinical genomics is still a nascent area in the informatics market, Hoffman said that Cerner is seeing “healthy demand” for products like PathNet Helix among its clinical customer base. “Clinical molecular diagnostics labs have been really trying to make the most out of the available applications, and they’re increasingly challenged by that,” he said.
As far as the potential market size for PathNet Helix, Hoffman said it probably doesn’t extend as far as every doctor’s office, but that there should be strong demand among reference labs, specialty diagnostic labs, and medium to large hospitals that have their own molecular diagnostics sections.
“It’s a considerable sized market,” he said.