NEW YORK (GenomeWeb) – Having refined its platform and manufacturing process, diagnostics firm HealthTell has now moved into clinical feasibility studies with the aim of launching its first test by the end of next year, CEO Bill Colston told ProteoMonitor this week.
Launched in 2010 as a spinout from Arizona State University's Biodesign Institute, San Ramon, Calif.-based HealthTell aims to commercialize diagnostics based on the immunosignaturing technology developed by Biodesign researchers, and company co-founders Stephen Johnston, Neal Woodbury, and John Rajasekaran.
Immunosignaturing uses random-sequence peptide microarrays to capture antibodies in patient blood samples. Based on the levels and patterns of antibody binding, researchers build antibody expression profiles that can then be correlated with various disease states.
According to Healthtell, the method has potential advantages over conventional protein biomarker-based tests in that it detects broad immune responses, which may provide a more comprehensive picture of disease states than a smaller set of markers. Further, the immune cell replication involved in immune response provides a natural amplification of the signal, making it possible to detect disease earlier than with conventional protein markers.
In a study published in July in Proceedings of the National Academy of Sciences, Biodesign researchers demonstrated the ability of the technology to detect a wide range of diseases, including early stage cancers. Looking at historical samples from 1,516 individuals across 14 different disease cohorts, including 249 healthy controls, and multiple stages of brain cancer, lung cancer, ovarian cancer, pancreatic cancer, pancreatitis, Ewing sarcoma, valley fever, and multiple myeloma, they found that they were able to classify these patients with an average accuracy of 98 percent.
This ability of the platform to simultaneously detect a wide variety of disease states across large panels of patients has in the past led the Biodesign researchers and HealthTell to suggest that it might prove suitable as a tool for regular screening of the general patient population. Indeed, in a 2011 interview with ProteoMonitor, Johnston said that the "big idea is that this is what healthy people will be sending in on a regular basis for diagnostic purposes."
This week, however, Colston told ProteoMonitor that, at least initially, HealthTell plans to focus on developing a test for a single indication, most likely in a high-risk patient population.
While the company's initial vision was for its first product to be used for the simultaneous detection and screening for multiple cancers, it became clear that this was not a practical approach for a number of reasons, Colston said.
For instance, he noted, it would be very difficult to build a validation study for simultaneous detection of more than one cancer in terms of putting together patient cohorts that accurately reflected the test's intended use.
And even if the company were able to move such a test through validation, driving adoption would likely prove equally challenging.
"If you launch a product that detects multiple diseases from a single drop of blood, who do you market that to?" Colston said. "It's different clinicians, different physicians, different intended uses."
Instead, Healthtell is opting for a serial release strategy that, while simpler than the initial vision, might still be considered somewhat daunting given the struggle many molecular diagnostic firms have had commercializing even a single product.
The plan, Colston said, is to launch a new test roughly every six months, starting with the initial launch scheduled for the end of next year.
"We thought that serial launches made a lot more sense and would be a lot cleaner in terms of messaging and additions to the platform as we go along," he said. He acknowledged, though, that these serial launches, too, will require significant investment.
"You have to do the clinical validation [and] the clinical utility. You publish the health economics. You verify the health economics. And then, at some point, you get the payors to sign up," he said. "I don't know that there is any … shortcut. It's a one- to two-year process, for sure – at least."
Colston said HealthTell has yet to settle on its first test but is currently conducting feasibility studies in various cancers, autoimmune diseases, and infectious diseases. These studies typically look at cohorts of around 100 to 200 patients, he said, adding that the company will roughly triple that number for its initial validation studies and then use cohorts approaching 1,000 patients for its final validation work.
As examples of the sorts of intended uses the company is interested in, Colston suggested tests for determining whether lung lesions detected on a CT scan are likely malignant or benign and tests for early detection of ovarian or breast cancer in high-risk populations.
HealthTell is currently building a CLIA lab to offer the tests.
The company's recent focus on test development has been enabled by refinement of its manufacturing system which has allowed for reproducible production of the high-density peptide arrays used in its tests, Colston said. Originally, the Biodesign researchers used arrays of 10,000 peptides printed on glass slides. However, since then, HealthTell has moved to a semiconductor substrate, which allows for more reproducible arrays featuring in the hundreds of thousands of peptides.
"We [now] have a pilot manufacturing capability where we are making thousands of arrays per month, and we have spent the last 12 months getting that process as reproducible as possible," Colston said.
Simultaneous with its feasibility studies, HealthTell is also doing a prospective study to compare patient results based on analysis of both dried blood spots and traditionally drawn blood. The hope, Colston said, is that DBS analysis will offer equivalent performance, which will allow more flexibility and lower costs in terms of patient sample collection.
"You can do [DBS sampling] in the doctor's office – you don't have to go to a blood draw facility," he said. "You can potentially do it in your house and mail it in. It just allows you a lot more access to patient samples."
Previous research by the Biodesign scientists, including the recent PNAS paper, has suggested that DBS sampling should prove effective on the platform.
In addition to its diagnostic development work, HealthTell has launched a pharmaceutical services business and signed several pharma clients, Colston said.
"We like that model because there are a lot of applications for drug discovery, and it helps pioneer new applications for us, helps validate the platform," he said. If the example of Somalogic's SOMAscan service business is any indication, it could also help with the company's cash flow if its diagnostic launches come more slowly than expected.
Thus far HealthTell has raised $13.5 million in funding, and Colston said he expects to raise another round this spring to hopefully take the company through its first commercial launch and to its first test revenue. He said the amount the company planned to target had yet to be determined.