The FDA move means officials at Blaze Bioscience, the private Seattle biotechnology firm formed in 2010 to launch the Tumor Paint platform, can proceed with the clinical trial, which includes sites at Cedars-Sinai Medical Center in Los Angeles, California, and the NEWRO Foundation in Brisbane, Queensland, Australia.

Twenty-one adult patients who need surgery for often-deadly glioma brain tumors are expected to enroll in the study, which is aimed at examining the safety of injecting the BLZ-100 molecule into the bloodstream, where it rushes to highlight cancer cells.

It may be especially beneficial for patients whose cancer might otherwise be difficult for surgeons to see – and remove, said Heather Franklin, the president and chief executive of Blaze Bioscience.

“We think that one of the benefits of this particular product is they may be able to see low-grade tumors,” she said.

It may help solve a long-standing problem in medicine: How to identify tumor cells so surgeons don’t remove too little, leaving disease behind – or too much, removing healthy tissue.

This first product based on Tumor Paint technology is a molecule that consists of two parts: a chlorotoxin protein that penetrates tumor cells and a dye that glows under near-infrared light.

“We believe it binds to a target protein on the surface of cancer cells,” Olson explained. “We believe (the target) is not present on the surface of normal cells.”

The chlorotoxin is the part that comes from death stalker scorpion venom, a discovery that Olson said came only after sorting through hundreds, if not thousands, of potential targets.

It’s chemically produced now; there’s no actual venom involved, Franklin said. Tests of the compound in skin cancer patients in Australia are ongoing, she added.

Participants are expected to enroll in the new trial through December 2015, according to the federal description. Patients must be adults ages 18 to 75 who meet a variety of criteria; eventually, Blaze researchers hope to test BLZ-100 in children, too.

The Phase 1 clinical trial is only one step toward routine use of Tumor Paint in hospitals around the world, Franklin said. It will be tested in brain tumors now, but preclinical evidence suggests that it may be helpful for a wide range of cancers, including lung, breast, prostate, colorectal, skin and sarcomas.

Olson, who is a founder of Blaze Bioscience, serves on the board of directors and is the firm's scientific director, said Franklin and others should be commended for getting a new product to this point so quickly.

"They moved from a licensed molecule to human clinical trials in record time and at a record low cost," he said. "When I tell pharmaceutical executives what the Blaze team has accomplished, it's a jaw dropper."

The firm has poured nearly $10 million from investors into the effort, said Franklin, who estimates that it could take five or more years before the product is ready for the commercial market.

"We will get it there as fast as we can," she added.