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Iris Biotech to Submit Microfluidics-Based Breast Cancer Chip to FDA by End of Year

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Iris Biotechnologies, a Santa Clara, Calif.-based diagnostics company, plans to submit its first assay to the US Food and Drug Administration for 510(k) clearance as an in vitro diagnostic by the second half of this year, according to a company official.
 
CEO Simon Chin told BioArray News last week that the test, called BreastCancerChip, designed to determine treatments for women with breast cancer, will become available as both a catalog product and as a service sometime this year.
 
BreastCancerChip uses a 100-gene expression signature plus an internally developed program that looks at medical history and lifestyle to recommend a treatment regimen for breast cancer patients.
 
The test differs from Agendia’s MammaPrint and Genomic Health’s OncotypeDx in that those assays test for disease recurrence. In addition, BreastCancerChip is a microfluidic chip rather than the spotted array employed by Agendia or the RT-PCR platform supporting OncotypeDx.
 
“They are only doing prediction of probable recurrence of breast cancer,” Chin said. “What we are doing with 100-plus genes is looking at how best to treat the patients from the beginning.”
 
While Iris is eager to battle Agendia in the marketplace, the firm also sees itself riding the Dutch company’s coattails through the FDA submission process. Agendia’s MammaPrint was cleared by the FDA in February 2007 (see BAN 2/13/2007). Chin said that because its test also relies on a gene-expression signature to make a diagnosis, the path has already been established for the BreastCancerChip to be cleared.
 
“Since Agendia set a precedent it will take less time for us to get approved,” Chen said. “We don’t need to reinvent the wheel.”
 
Lifestyle Expression
 
The main differentiator in Iris’ approach is its BioWindows program, which combines the information from the BreastCancerChip with medical history and surveys about lifestyle to produce a report that Chin believes will tailor treatment to an individual. Iris can hypothetically stratify patients into those that will best respond to certain treatments.
 
“Our advantage is that we have another product used in conjunction with our chip,” said Chin, referring to the BioWindows tool, which addresses a patient’s epigenetic profile as well as her medical history and lifestyle to determine how she might respond to different therapies.
 

“Since Agendia set a precedent it will take less time for us to get approved. We don’t need to reinvent the wheel.”

“We have a comprehensive medical survey so that we can subgroup patients not only according to gene profile, but also according to demographics and lifestyles,” Chin said. “It is the totality of pictures that gives us the ability to do this kind of clinical analysis.”
 
Referring to the company’s microfluidics technology, Chin said that Iris was founded “with the goal to overcome limitations associated with array technology.” While Chin didn’t elaborate, the company said in a filing with the US Securities and Exchange Commission last year that it believes that microarrays "lack the necessary test sensitivity, gene marker specificity and speed for the best and most cost-efficient medical decision-making and patient care."
 
Arrays, the company said, "will ultimately prove to be clinically less useful and too expensive for large-scale use" because "clinical diagnostic testing requires a highly sensitive platform that provides very specific findings at an affordable price." 
 
Chin said that the company also ruled out RT-PCR because it “would be prohibitively expensive, and the process will take longer as well.”
 
Chin declined to discuss pricing for the BreastCancerChip test, but said that Iris is looking to be cost competitive with MammaPrint and OncotypeDx.
 
The company is estimating that the market for its test is worth around $2.5 billion in the US. “Annually there are approximately 2 million biopsies done in the US,” said Chin. “In Europe, this number is slightly higher. Those are the potential breast cancer biopsies that can be looked at using our test.”
 
The BreastCancerChip will be marketed in two ways: Iris will directly market and sell the chip to major hospital networks as well as clinical labs, while the firm will use “various distribution networks” to market the test to smaller labs, Chin said.
 
Public Company
 
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.
 
However, Chin said that the launch of both chips will “be dependent on the worldwide result of different studies on various genes affiliated with cardiovascular disorders and neurological disorders.
 

“From our side, assuming that there is sufficient understanding of the genes that are involved, we can create a new product,” Chin said. “The limiting factor is that the global scientific community is still doing a lot of research on these disorders, and current knowledge on these disease areas is insufficient. That is the reason why we have not introduced these chips. We will introduce these products when we feel there is sufficient correlation between these genes and diseases.”