Private investors have staked $50 million on the future of Aureon Laboratories Inc., a Yonkers biotech company. They'll soon know if it was worth it as Aureon prepares to take its first major service to market.

Prostate Px+ is a diagnostic tool that uses sophisticated technology and advanced mathematics to analyze tissue samples from men with prostate cancer following their diagnosis.

Aureon says its techniques can predict how serious the cancer will become, allowing doctors and patients to make more informed decisions on how aggressively to treat the disease.

The company was founded by three molecular pathologists in 2001. It has research collaborations with pharmaceutical giants such as Pfizer and Astra Zeneca.

"It's been a long seven years getting to this point," said Vijay Aggarwal, Aureon's president and chief executive. "We've spent a lot of money. We believe we've spent it wisely. We think the market demands and deserves rigorous clinical development and validation, which is expensive."

The company employs about two dozen people at its offices at the former Otis Elevator building near Getty Square. By year's end, the staff will double as the company adds a sales force to market Prostate Px+ across the nation.

Aggarwal said Aureon is seeking another $35 million for the expansion and more research into other applications for its patented technology. Aureon introduced its centerpiece this month at the annual meeting of the American Urological Association in Orlando, Fla.

Jason Alter, the company's marketing director, said interest at the convention was high.

"It's been accepted for a long time that there's a tremendous need for what this test does," he said. "When you read the literature and go to the meetings, this is what everybody talks about."

About 220,000 men are diagnosed with prostate cancer each year, and 30,000 men die from it annually. After lung cancer, it's the second leading cause of cancer death among men.

About 85 percent of men who are diagnosed with prostate cancer are classified as facing low or intermediate risk of death, yet many who subsequently die from the condition fall within these classifications. Others may opt for aggressive treatment, such as radiation therapy or removal of the organ, and subsequently suffer burdensome side effects such as incontinence or impotence.

The demand for knowing how bad such cancer can become is keen. Aggarwal, the former executive vice president of laboratories for SmithKline Beecham Clinical Laboratories, estimates the market for such prognostic tests as Aureon's at $500 million.

Using high-resolution digital images, Aureon studies the molecular circuitry of a patient's cancer tissue on a pixel-by-pixel basis. Computers sort through thousands of bits of data that are gleaned from the samples to chose specific data that can offer meaningful sense of how the cancer will progress.

Statistical models help place a patient on a scale of 1 to 100, with low numbers representing the least risk from the disease. Alter said the list price for the test is $3,000. Such tests do not require approval from the U.S. Food and Drug Administration, although the FDA is evaluating whether that's necessary, he said.

Dr. Howard Soule, executive vice president of the Prostate Cancer Foundation, said Aureon is one of several researchers that are trying to develop better diagnostic tests in the field. He declined to comment on the efficacy of tests.

"I would say that's a very large market and a very important thing to do," he said. "Most of them (men with prostate cancer diagnosis) are treated aggressively because the physician can't tell the difference between one (tumor) that's unimportant and one that's going to be lethal."

Reach Jerry Gleeson at jgleeson@lohud.com or 914-694-5026.

Dr. Ricardo Mesa-Tejada, medical director and vice president of pathology, digitally captures a patient's protein expression profile Wednesday on the MIDAS system at Aureon Laboratories in Yonkers. Aureon has developed a new test for prostate cancer patients that is designed to assist physicians as they counsel patients on the range of treatment options and on probability of disease recurrence and progression. (Anya Savayan/The Journal News)