In its first product launch, a 6-year-old biotechnology company in downtown Yonkers has marketed a prognostic lab test that could spare some prostate cancer patients from unneeded treatment and save the lives of other men in whom the disease”™s high-level risk cannot be predicted by conventional measures.
Aureon Laboratories, whose headquarters and laboratories are in the i.park Hudson office complex at 28 Wells Ave., early this year launched its Prostate Px test on the East Coast. Using a patient”™s biopsy tissue after a diagnosis of prostate cancer, the test applies proprietary image analysis technology to cancer cells, molecular analysis of proteins and advanced mathematics to predict the disease”™s severity and risk of recurrence.
“It”™s a way of being able to look at tissue samples and personalize” the data, said Aureon Laboratories CEO and President Vijay Aggarwal. The test is designed for use by physicians and must be ordered by one.
Annually, about 218,000 men in the nation are diagnosed with prostate cancer and 30,000 die of the disease, making it the second-leading cause of cancer deaths and seventh-leading cause of death overall among American men, according to the National Cancer Institute. With early detection, prostate cancer is treatable and has a high cure rate. If detected while still in the prostate gland, the five-year survival rate is nearly 100 percent, according to the American Cancer Society.
Yet, since no consensus on best treatment exists among physicians, most patients must choose from a variety of treatment options, ranging from removal of the prostate to “watchful waiting.”
Each year about 186,000 newly diagnosed men are grouped into low or intermediate risk categories for the disease. But about 10 percent of those patients eventually will die of prostate cancer, Aggarwal said.
“It”™s not necessarily a better tool for diagnosing prostate cancer,” he said of Prostate Px, “but once it has been diagnosed it better guides the physicians and patients” in deciding what the next step should be. If the test indicates a low probability of progression, therapy might be deferred for five years, he said. “For others you can”™t afford to wait and this test helps you determine whether you need aggressive therapy right away.”      Â
The test could serve to reduce the number of patients receiving treatments, which include radiation and hormone therapy and all of which have potentially adverse side effects, such as impotence and incontinence. Today, “Essentially we”™re overtreating cancer once it”™s been diagnosed,” Aggarwal said.
Aureon officials said the product was based on results of a large study using data and tissue samples from a group of 1,027 men assembled from the Mayo Clinic, Sweden”™s Uppsala University, the University of Connecticut and Duke University Medical Center. The company”™s predictive model identified twice as many high-risk events in low- and intermediate-risk patients than did the best available method for prognosis.
Since launching the product last January in the Northeast, Aureon has hired sales representatives from Boston to Miami and now is hiring on the West Coast, Aggarwal said. Having had a “very positive” response to the new product from physicians and prostate cancer support groups, the company plans to have a nationwide sales force of 20 to 25 people by early next year. About 35 office and lab workers are employed in Yonkers, where more medical technologists and pathologists are being hired as a result of the product launch, the CEO said.
To date the company”™s revenues ”“ about $1 million this year ”“ have come largely from its laboratory research work with medical and scientific collaborators in both the United States and Europe, which include the Memorial Sloan-Kettering Cancer Center in New York, the University of Texas M. D. Anderson Cancer Center and Cancer Research UK in London, England. “2008 is really a year of launching the test, building up the sales force, increasing the visibility, and we expect a significant increase in revenues in 2009,” Aggarwal said.
The company plans to expand into prognostics for other forms of cancer and disease, particularly small cell lung cancer, melanoma and breast cancer.
“Having spent five years in developing the technology, it”™s a technology that”™s applicable to a wide variety of tissue types,” Aggarwal said. “We haven”™t made that final decision about where we would next apply the technology.”
Aureon”™s proprietary technology, by measuring androgen receptors in men, higher levels of which are associated with tumors, also could be used to predict responses to therapies for prostate cancer patients.
“Until our technology was developed, there wasn”™t a great way of measuring androgen receptors in prostate cancer patients,” the CEO said. “Hopefully in five years you will not treat a prostate cancer patient until you know the androgen receptor capacity of a patient. That”™s a future application.” Aureon could introduce its therapeutic-outcome predictor in one to two years, he said. Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â
The company was started in 2002 with a $23 million venture-capital investment, Aggarwal said. Investors include New Leaf Venture Partners/Sprout Group, BD Ventures, Pfizer Strategic Investments and Atlas Venture.
“We already have spent about $40 million in development of the assay, commercial infrastructure and getting us to this point,” he said.
Starting with 14,000 square feet at i.park Hudson six years ago, the company has expanded into 20,000 square feet, which includes 9,000 square feet of laboratory space.  Â
“At the end of the day, this is a state-of-the art molecular pathology facility,” said Charles J. DiComo, Aureon director of laboratories, who has been with the company since its start and oversaw the initial build-out of corporate offices and clinical labs. Â Â Â Â
