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Biotechs aim for noninvasive prostate cancer biopsies

What if doctors could screen men for prostate cancer without a painful, and often unneeded, biopsy? A handful of biotech firms are working on techniques that would instead use simple blood or urine tests -- and that could result in a new multibillion-dollar business.

A company called OPKO Health (OPK) has a new procedure involving a blood draw that aims to find whether a man has a dangerous cancer lurking in his prostate -- or not. "We can eliminate 60 percent of the biopsies," said David Okrongly, the firm's president. "A lot of men don't need them anyway."

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A competitor, Belgium-based MDx Health, bills its approach as completely noninvasive because it doesn't even use a needle; it's the one that analyzes a patient's urine. "Of the more than 2 million prostate biopsies performed each year, less than a third find cancer," the company said in a statement. "Most of these men could have avoided a painful and invasive procedure."

Meanwhile, Illumina (ILMN), the world's largest maker of DNA sequencing devices, has launched a company known as Grail to develop a gene-based cancer test for the prostate, but also for all other forms of cancer from breast to lung. Backed by a group of A-list investors that includes Bill Gates, Grail hopes to have this blood test ready by 2019.

The other two companies analyze enzymes. OPKO calls its approach the 4-K score, because it evaluates four enzymes. Its chief executive is billionaire drug entrepreneur Phillip Frost.

Prostate cancer, the second deadliest for men after skin malignancies, claimed 27,540 lives last year, according to the American Cancer Society. Typically, men over 50 get an initial test for prostate problems during their yearly checkups, using a blood sample that measures a protein called prostate specific antigen, or PSA. If the PSA level is high, the next step usually is a biopsy.

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Health statistics show that 60 percent of prostate biopsy recipients have no sign of cancer; 20 percent have a slight trace of it that bears watching, but may go nowhere; and 20 percent are at risk and should have the gland removed.

In a biopsy, a long device is inserted up the rectum, and then as many as a dozen needles are fired into the walnut-sized prostate to get tissue samples, which are evaluated for evidence of cancer. Because the derriere is bacteria-laden, an estimated 4 percent of biopsy recipients end up in the hospital with infections. At best, a man will experience internal aching and days of urinating blood.

A prostate biopsy costs about $2,000, although it can be double or triple that. The operation to remove the prostate isn't cheap. A study by the Journal of Urology pegged the average at around $35,000, and health insurance doesn't always cover the tab. Medicare may reimburse only half of it.

OPKO said its blood-draw test costs a little more than $1,000, and MDx's urine exam lists at $500. Both are eligible for health insurance coverage.

At this stage, the PSA test likely will remain the first screen for prostate cancer because it's less costly than the liquid biopsies.

Nothing involving surgery is pleasant, of course. "The treatment of cancer can be harmful," said Dipin Parekh, chairman of the urology department at the University of Miami, who isn't affiliated with the biotechs producing biopsy alternatives. He prefers OPKO's approach as "best in class."

In business terms, the potential for a big payoff from a liquid biopsy is intriguing, although the risk is high for any new medical procedure. OPKO, which also deals with human-growth hormone and kidney treatments, had a huge stock run-up in 2015's first half. That deflated after it bought clinical lab Bio-Reference in June.

OPKO is unprofitable, like rival MDx, which is the norm for biotech outfits. But analysts expect that to turn around. Barrington Research projects OPKO to swing into the black this year, partly on the strength of the 4K prostate test. A big help will be the added revenue from Bio-Reference, plus the muscle of its 400 sales reps.

Larry Feinberg, managing partner of Oracle Investment Management and owner of OPKO stock, believes the prostate test will boost OPKO's annual revenue by up to $1 billion, from 2015's estimated $480 million.

Other companies looking at improved prostate screening focus on analyzing tissue after a biopsy, hoping to better determine the threat level. Genomic Health (GHDX) has a procedure called Oncotype DX that examines 17 genes from a sample to predict how aggressive the condition is.

If the liquid biopsy does take off, at least prostate screening would be a little more bearable.

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