By Tony Fong
NEW YORK (GenomeWeb News) – Diagnostic companies developing biomarker-based tests usually work with patient samples from subjects who already have a disease for comparison with samples taken from healthy subjects.
But leveraging a biobank that it has licensed from University College London, UK firm Abcodia is betting that samples that allow researchers to track changes in patients going back years to before the onset of disease and through the progression of disease can provide new methods of disease detection.
Founded last month, Abcodia is seeking partners to develop tests from biomarkers discovered and validated from the biobank, and is now in discussions with drug manufacturers, molecular diagnostic platform firms, and test developers about potential collaborations.
The value proposition that Abcodia's serum biobank offers, Julie Barnes, the firm's CEO, told GenomeWeb Daily News, is that because of the longitudinal nature of the study for which the serum was collected, the samples may open new avenues of research for biomarker discovery and provide clues to the development of various diseases that other patient samples wouldn't.
Unlike traditional methods of sample collection for diagnostic test development, the samples from UCL were collected starting a decade ago and include preclinical samples from patients who were healthy when they first donated, but then eventually developed various diseases.
It is this change in health state within single patients that Abcodia believes will offer a game-changer in biomarker discovery.
The serum was collected by Ian Jacobs, the principal investigator on the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Now the vice president and dean of the faculty of medical and human sciences at the University of Manchester, UK, Jacobs had been the dean of biomedical services at UCL.
About 10 years ago, Jacobs began the UKCTOCS trial, directed at evaluating the use of the protein CA-125 and ultrasound scanning as screening methods for ovarian cancer, which was anticipated to last 15 years. Writing to about 1 million women in the UK, he eventually signed on about 200,000 women to participate in the trial.
After using the serum they collected for their research, Jacobs and his colleagues froze the serum, resulting in 500,000 samples from the 200,000 trial participants. About 50,000 of those participants have provided serum samples each year for the past seven or eight years.
Because the participants had to have a diagnosis of no cancer at the time they started the trial, and the samples are preclinical, "we're in a unique position of having serum samples collected before diagnosis of any age-related condition," including not only cancer but other illnesses as well, such as diabetes, osteoarthritis, and rheumatoid arthritis, Barnes said.
Data was also collected on the subjects' lifestyle factors, such as smoking status and alcohol-consumption status, offering further data that may be useful in analyzing disease development and progression.
"We have quite a unique opportunity to work with various communities to help validate and advance diagnostics for screening indications," Barnes said. "Because we have cancers and non-cancers, we can also align specificity studies. We can check, for example, if a biomarker is specific for pancreatic cancer over other pancreatic conditions … as well as do these nice longitudinal designs by having each subject used as [his or her] own control."
While not common, a few other research efforts have taken a longitudinal approach similar to the one that Abcodia is advocating. In 2009, BG Medicine, the National Heart, Lung, and Blood Institute, and Boston University began collaborating with researchers from the Framingham Heart Study to develop blood tests for heart disease and stroke, using frozen blood samples, imaging studies, and other medical test results collected during the 60 years of FHS.
And in August, Sigma-Aldrich reached a deal with NHLBI and BU to develop methods of measuring potential biomarkers for atherosclerosis cardiovascular disease in plasma samples from FHS.
Abcodia has been granted the rights to commercialize the IP from the UCL biobank, and while Barnes said that the company may eventually do some of the biomarker research itself, doing so would require significant investment to build out the scientific capabilities of Abcodia, something it does not plan to do at the moment.
"We don't want to invest lots and lots of money developing biomarkers on our own without having a sense where that biomarker would be taken," she said.
She didn't name any of the companies that Abcodia is in discussions with for potential partnerships. As a model of the type of collaboration that would be ideal for her firm, Barnes cited a recent agreement between UCL and Becton Dickinson. In such an arrangement, the diagnostic partner would be a well established firm and provide expertise in the regulatory and commercialization pathways.
In addition to major diagnostic firms, Abcodia is exploring teaming up with niche players interested in specific disease areas, as well as technology firms performing biomarker discovery and development work.
There is "a lot of interest" in DNA methylation and microRNA, as well as autoantibodies and protein-based biomarkers, and players with platforms that can run tests with such biomarkers, "are of interest to us," Barnes said.
Drug firms interested in how diseases progress and the identification of biomarkers "that may help them identify new mechanisms and new drugs for therapy" are also potential collaborators, she added.
The firm has secured seed financing and is in the process of closing a Series A tranche, Barnes added. The tranche is anticipated to close in a couple of months, though she declined to say how much Abcodia is targeting in the round.
At the moment, Abcodia consists of two employees, Barnes and Chris Hodkinson, the chief operating officer. Prior to joining the company, Barnes was the CSO at healthcare technology firm BioWisdom, where Hodkinson was the COO.
Last week, Andy Richards joined the company as chairman. Once additional funding is secured, the company will hire additional staff with an emphasis on people with backgrounds in business development to target collaborations and partnerships.
Barnes added that Abcodia also will seek scientists to strengthen its analytical capabilities, particularly in the areas of cancer research and molecular biology.