Predictive Diagnostics, a wholly owned subsidiary of Large Scale Biology Corporation, has begun collaborating with the University of Utah Research Foundation to identify proteomic profile biomarkers for early diagnosis of pregnancy-related complications such as pre-term birth and preeclampsia, the Vacaville, Calif.-based company announced this week.
Predictive Diagnostics plans to perform mass spec and data analysis on samples provided by the University of Utah, and to commercialize the pregnancy-related biomarkers after the markers have been published and validated, said Gershon Wolfe, the chief scientific officer of the company.
The disclosure follows an announcement last week by Predictive Diagnostics that it had developed a diagnostic for multiple sclerosis with Wake Forest University Baptist Medical Center. Results of a study using the preliminary blood test for MS were published in the March issue of the Journal of Molecular Neuroscience.
“We’re getting very good results [for biomarkers] looking at lower molecular weights,” said Wolfe. “We’re continuing to refine our technique further and further. As it stands now, we’ve got a product that works, and we’re working on establishing other collaborations [with both academia and industry].”
Predictive Diagnostics’ search for proteomic diagnostic biomarkers is based on the company’s flagship Biomarker Amplification Filter software. The idea behind the software is that it filters through mass spectra of diseased and control samples and finds the disparate features between them. Eventually, a pattern profile that typically consists of about 8 to 12 biomarkers is honed in on and used as a diagnostic tool for a disease or condition.
Predictive Diagnostics’ BAMF technology is different from other biomarker technologies in that it identifies a pattern profile, without identifying the proteins represented by the profile. Wolfe said that the company has had discussions with the US Food and Drug Administration about such a technology being approved, and has come to the conclusion that approval of a pattern profile is not necessarily harder than approval of a panel of identified biomarkers.
“An image is a pattern,” Wolfe pointed out. “An ultrasound is a pattern. A CAT scan is a pattern. [Diagnostics based on patterns] are done all the time.”
The next step after identifying a pattern profile would be to identify the proteins that make up the pattern and to characterize their function, but right now Predictive Diagnostics is just concerned with the pattern itself, Wolfe said.
“From a diagnostic point of view, if you can differentiate a disease from a benign condition, that’s something you can tie a nice ribbon around,” said Wolfe. “The next step would be to characterize the proteins, and we want to pursue that in the future, but we can’t put the cart before the horse. We’ve got to get the diagnostics brought to market first.”
As part of their deal to develop the pregnancy-related diagnostics, Wolfe said the University of Utah would be providing Predictive Diagnostics with several different sample sets, as well as proprietary purification procedures. The samples would be used for retrospective studies, as well as a prospective study with over 600 samples, Wolfe said.
“We’re going to perform the mass spec and data analysis, and the plan is that we want to publish this and commercialize this,” said Wolfe.
In terms of the multiple sclerosis blood test, Wolfe said that Predictive Diagnostics is looking to validate the test through a prospective study. The company is looking at both the traditional Premarket Approval-route with the FDA, and the “home brew” route to get the diagnostic to market, Wolfe said.
In addition to developing diagnostic biomarkers for multiple sclerosis and pregnancy-related complications, Predictive Diagnostics is also working on biomarkers for breast, lung, pancreatic, and prostate cancer, and for Alzheimer’s disease.
“Our platform is disease independent,” said Wolfe. “It doesn’t have to be cancer. It can be all kinds of conditions. One of the more exciting areas right now is the idea of being able to use this technology in preclinical trials for drug development to weed out responders from non-responders. This is very important and it’s applicable to any therapeutic.”
To illustrate his point, Wolfe pointed to the pain medication Vioxx, which Merck recently withdrew from the market because of life-threatening adverse events. Vioxx “works great on some people, and on others it’s devastating,” Said Wolfe. Predictive Diagnostics’ BAMF technology could be used to develop a screening test that could weed out those patients for whom the drug will be effective on, he said.
While Predictive Diagnostics is not specifically working on a Vioxx screening test, it is working on developing screening tests for other drugs, Wolfe said.
“Definitely it’s going to benefit the drug companies immensely,” he said. “It helps put the drug out into the market, and the drug becomes a patient-tailored therapeutic.”