In cancer treatment, speed is of the essence. More rapid detection of breast cancer can reduce the painful waiting game most women go through from the time a mammogram reveals something noteworthy to the time a diagnosis of a benign or cancerous lesion is pathologically diagnosed. Reducing this time will save literally thousands of lives, and Itsi-Biosciences (Itsibio) is working hard to make it a reality.
| Itsibio serves as an extension of a client’s laboratory to expand their analytical capabilities and productivity without incurring additional personnel and/or capital equipment costs. |
"With our bio-marker technology, doctors will be more accurate in pinpointing the specific nature of the cancer," says Richard Somiari, Itsibio CEO. "This can dramatically increase the effectiveness of the prescribed treatment."
BFTP funded Itsibio with $125,000 in September 2005 to help bring the bio-marker technology through clinical trials and to commercialization. The company expects FDA approval soon after the validation process and a clinical trial that should last two to three years.
Identifying Key Indicators at the Genetic Level
"Typically, there are proteins or genes in the blood with very specific characteristics that help distinguish between a normal and diseased state," Somiari says. "Our technology tests the blood and identifies these characteristics to determine if a specific cancer is present."
Itsibio's technique is based on a process known as PCR, or Polymerase Chain Reaction. According to Somiari, there are about 100 biomarkers in the blood. Itsibio has discovered that about 15 of these markers -- in specific combinations -- can be used to better classify individuals who have a condition.
"By being able to quantify and detect those 15 markers, we are able to provide better care management and increase survival rates," Somiari says. "The specific level of each marker is very important."
| — Richard Somiari, CEO, Itsibio |
Complementing Current Protocol
While the technique may eventually be applied to other cancers, Itsibio is specifically targeting breast cancer. Each year, approximately 250,000 women are diagnosed with breast cancer and some 40,000 die.
Most experts agree that early detection is directly linked to improved survival rates and, though 32 million mammograms are conducted annually, that test can't clearly show whether a growth or lesion is benign or cancerous.
"Our test will complement current protocols and enable a more objective method for early detection," Somiari says.
Reducing the Wait Time
For most women, the waiting period from seeing something suspicious on a mammogram to the diagnosis -- which involves a biopsy and can take a week or longer -- is the hardest part. "With our technology, after a suspicious mammogram the doctor can order blood drawn and, within a day or two, have conclusive results back," Somiari says. "With cancer, every day matters."
In addition to more rapid and less invasive detection, the technology will enable doctors to more accurately classify a suspicious lesion. "Today the most typical treatment is chemotherapy," he says. "In the future, we will be able to better classify the disease both at the genetic and protein level which will then help doctors prescribe better and more specific treatment."
Where Business Meets Medicine
Beyond the financial investment, Somiari says BFTP has been an amazing resource for his start up. "(BFTP's) Transformation Group has been an amazing asset on the business side, working with us on everything from accounting issues to helping us fulfill a contract Itsibio has with the National Cancer Institute," he says. "We wouldn't be where we are today without their help."
Itsibio isn't relying solely on third-party funding to make its biomarker discovery a reality. The company currently generates revenue through the manufacturing and sales of reagent kits and by putting their specialized analytical skills to work through in-lab services and provision of support services to biomedical researchers in academia and industry worldwide.
Itsibio manufactures and sells six different reagent kits to labs that want to conduct their own protein analysis. They currently sell kits all over the country as well as Brazil, Mexico and Chile. In September 2005, Itsibio began talks to export into the Indian market.
"With one billion people in the country, there is huge potential. Our kits are so unique we envision market penetration once enough awareness is raised. Then our biggest challenge will be expanding our manufacturing space. We currently receive samples and requests for project works from all over the world," says Somiari.
The company serves as an extension of a client's laboratory, expanding their analytical capabilities and productivity without incurring the burden of additional personnel and/or capital equipment costs.
From the November/December 2005 issue
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