With $30 million in recent financing, a Seattle-based company has launched operations to develop and market inexpensive tests for thousands of blood proteins, offering a comprehensive picture of the health of all the body’s organs. The Seattle startup, called Integrated Diagnostics, is developing cheap diagnostics that work in minutes and could be used to detect diseases at early, more treatable stages. The company’s technology has been in development for the past nine years in labs at the University of California, Los Angeles, and at the Institute for Systems Biology in Seattle. The company hopes to provide tests for early diagnosis of neurological disorders and other diseases.
Today’s diagnostic tests tend to focus on a single disease marker, such as the prostate-specific antigen (PSA) test that’s used as a predictor of prostate cancer. However, such tests are unreliable and often inaccurate. Integrated Diagnostics’ technology is based on a systems biology approach that leverages large amounts of information about various biomolecules associated with health and diseases. Leroy Hood, one of the company’s founders, is also the founder and president of the Institute for Systems Biology. Instead of focusing on one gene or protein at a time, systems biology, Hood says, is based on “the idea that diseases arise from a perturbed network” of many genes and proteins.
Using such an approach, diseases like cancer can be detected much earlier, and researchers can determine how aggressive a disease is and how far it’s progressed. Researchers can even predict which therapies will be most effective for individuals. “PSA is deemed by many people to be a failure because of high rates of false positives” that happen when focusing on a single indicator, says Hood. “You have to have multiple parameters.”
While the systems approach has borne fruit in the lab, it hasn’t yet been brought to the clinic, says Paul Kearny, president and chief scientific officer at Integrated Diagnostics. That’s because of the expense and complexity of these more comprehensive, multiple-parameter tests. Integrated Diagnostics is focused on detecting proteins present in the blood. Testing for blood proteins with today’s technologies is time-consuming and too expensive to scale up. The PSA test is about $40; detecting other proteins can cost upwards of $500 for a single test. Kearny says Integrated Diagnostics plans to drastically reduce these costs. “It’s realistic with our technology to get the measurement costs down into pennies,” he says.
The company is developing an inexpensive microfluidic chip that can rapidly process a single drop of blood in 10 minutes to separate out proteins that act as health markers. The chip was developed by Hood and James Heath, a professor of chemistry at Caltech and another cofounder of Integrated Diagnostics. A key part of the chip is a second technology licensed by the company and developed by Heath: protein fragments called peptides that capture blood proteins of interest. These capture agents are more stable and cheaper to manufacture than the antibodies that are usually used for such tests.
The company has also licensed a large database of organ-specific proteins amassed by researchers at the Institute for Systems Biology. The advantage of the organ-specific approach, says Kearny, is that it will allow a doctor to determine not just what a disease is but where it’s causing problems. If a breast cancer recurs and metastasizes to the lungs, for example, that organ will shed proteins in the blood that could help doctors detect the tumor location with a blood test.
Current versions of the diagnostic technology being tested in clinical trials at the University of California, Los Angeles, monitor 35 blood proteins in order to evaluate patients’ responses to treatment for aggressive brain and skin cancers. The tests require only a single drop of blood and 5 to 10 minutes to complete.
Integrated Diagnostics has not yet announced which diseases its products will target. Possibilities include central-nervous-system disorders such as Creutzfeldt-Jakob disease, Alzheimer’s disease, and brain cancer. Hood’s lab has amassed a database of proteins in the blood that come from the brain and can be used to detect these diseases early and follow their progression.
Kearny says the company will spend the next three years developing its first products.