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Iris Biotech Views Its Informatics Platform As Competitive Edge in Genomic Dx Market

Iris Biotechnologies, a developer of microfluidics-based molecular diagnostics, is currently beta-testing a comprehensive database and software system that it expects to give it a boost over its rivals in the competitive genomics-based breast cancer testing market.
The platform, called BioWindows, is an artificial intelligence system that acquires and analyzes genomic hybridization information from the company’s microfluidic chips and then compares that data with a repository of hybridization profiles, patient profiles, reference information, clinical information, and other data in order to provide appropriate treatment scenarios for individual patients.
The key to the system is an interactive survey that allows patients to enter their personal information and medical history through a secure, online interface. The company plans to collect as many of 1 million such profiles in order to refine the platform in an iterative fashion.
“The informatics side is extremely important because when you talk about the human genome or how best to treat patients or develop new drugs, it’s all about getting the right information and being able to piece together, in our case, a patient’s personal medical history as well as family medical history, with lifestyle, with exposure, and other relevant information,” Simon Chin, CEO of Iris, told BioInform.
In the BioWindows survey, “we ask hundreds of questions, and that information goes into the database, and then we combine this information with the information from the chip so it makes a really powerful platform,” he said.
Chin said the company is not disclosing the number of patients who have already submitted data into the system, but he said that it is aiming for a million profiles eventually. “We don’t need a million people for what we plan to do, but the more we have participating, the more refined the information becomes,” he said.
Iris plans to partner with breast cancer advocacy groups, research groups, and physicians in order to encourage further participation in the BioWindows database, Chin said.
The system will ultimately be able to recommend specific cancer treatment regimens based on the collection of profiles in the database, Chin said. “The biggest question that people will have is related to chemotherapy. There are more than 30 chemotherapy agents in use, and which combination of those will actually work for the patient? Today, doctors don’t know, so it’s a trial-end-error process,” he said.
Chin noted that the survey tracks information such as the treatments that are given to patients, as well as whether those patients survived or not — information that can be used as part of a predictive tool once it is aggregated with similar data from other patients.
“Let’s take, for example, an Irish woman aged 40 to 45. Say she drinks a fair amount but she doesn’t smoke. And let’s say she’s been exposed to various diseases and a certain amount of stress and a whole host of other questions that come into play,” Chin said. “If you subgroup these people, then a pattern would emerge that would show that maybe for this group of people one particular chemotherapy might work better.”

“We ask hundreds of questions, and that information goes into the database, and then we combine this information with the information from the chip so it makes a really powerful platform.”

The technology underlying BioWindows is protected under a patent awarded in 2006, US No. 7,062,076, entitled “Artificial intelligence system for genetic analysis.”
But BioWindows is only half of the company’s business. Iris has also developed a proprietary silicon biochip platform for analyzing gene-expression patterns that it believes offers a number of advantages over microarrays or PCR in diagnostic settings. 
Chin last week told BioInform sister publication BioArray News that the company plans to submit its first assay on the platform — a 100-gene breast cancer diagnostic called BreastCancerChip — to the US Food and Drug Administration for 510(k) clearance as an in vitro diagnostic by the second half of this year.
In a prospectus filed with the US Securities and Exchange commission in December, the company acknowledged that it faces competition in this market from Genomic Health, which markets the PCR-based Oncotype DX test for breast cancer recurrence, and Agendia, which recently received FDA approval for its microarray-based MammaPrint breast cancer test.
The company said in the filing that its management “believes that research-based microarrays lack the necessary test sensitivity, gene marker specificity and speed for the best and most cost-efficient medical decision-making and patient care.”
PCR, meanwhile, “is a practical system to use for clinical diagnostic if it is used to detect only a few genes,” but would be “too expensive to use to detect 100 or more genes in a clinical setting to obtain the gene profile necessary for predicting the best treatment regimen for an individual patient.”
The company is also differentiating itself from its competitors in its application of the technology. Chin told BioArray News that while companies like Genomic Health and Agendia are focused solely on predicting probable recurrence of breast cancer, “what we are doing with 100-plus genes is looking at how best to treat the patients from the beginning.”
The company believes that the market for its test is worth around $2.5 billion in the US, based on an estimate of around 2 million biopsies each year.
Chin founded Iris in 1999. In December 2007, the firm filed a prospectus with the US Securities and Exchange Commission to go public.
According to the filing, the firm incurred an accumulated net loss of around $5 million between the time it was founded and Sept. 30, 2007, and generated no revenues during that time. Iris had five full-time employees and 10 part-time staffers as of Dec. 3, 2007.
As of Sept. 30, 2007, the company had $251,000 in cash. It expects to spend around $1.5 million this year to get the BreastCancerChip approved in the US.
Iris said in the filing that it plans to price its shares at $2.25 each. Based on 10.7 million shares currently outstanding, it could raise as much as $24 million in an IPO.
A company spokeswoman said that Iris expects to begin trading publicly on the over-the-counter bulletin board under the ticker symbol IRSB.OB "in the near future." 
The company also has several other diagnostics in the pipeline, including a CardioChip for detecting and treating heart disease, and a NeuroChip, designed to diagnose degenerative neurological disorders such as Alzheimer’s disease and Parkinson’s disease.
Chin said that the company is collecting information on these disease areas through the BioWindows survey so that it will become part of the predictive platform in the future.

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