From Center research, a good birth

Cancer study leads to unexpected creation of a product to help predict risk of premature childbirth
pregnant woman
"FullTerm, The Fetal Fibronectin Test" helps doctors determine whether a woman is at imminent risk of premature delivery. The product's creation demonstrates the ripple effect of the Center's cancer research. Hutchinson Center File Photo

Dr. Sen-itiroh Hakomori has spent a lifetime studying the dynamics of cell growth and movement in hopes of improving the treatment of cancer and other diseases. Along the way, the former Hutchinson Center scientist unlocked a door to an unimagined outcome — better care for pregnant women.

From 1972-87 Hakomori was head of the Biochemical Oncology Program at the Hutchinson Center. In 1973, Hakomori and Dr. Carl Gahmberg, a postdoc from the University of Helsinki working in his lab, described a macromolecule that helps cells adhere to nearby materials in their environment. The macromolecule was later named fibronectin.

Hakomori was looking for clues about how cancer cells come unglued and spread — or metastasize — from one part of the body to another. At first, nothing suggested that fibronectin could help predict a pregnant woman's risk of giving premature birth. But it does. Nor was there any hint it would become the backbone of a thriving company with more than $50 million in annual sales. But it did.

"We were not expecting that kind of thing to happen when we found oncofetal fibronectin, but I'm very pleased with the outcome," said Hakomori, now head of the Division of Biomembrane Research at the Pacific Northwest Research Institute in Seattle.

"That's the thing about science," said Spencer Lemons, vice president for Industry Relations and Technology Transfer at the Hutchinson Center. "One thing leads to another and you never know what kind of impact it's going to have."

In addition to working toward the elimination of cancer and related diseases as causes of human suffering and death, the Center recognizes the need to turn basic knowledge into products that benefit the public. By patenting and then licensing discoveries made by its scientists, the Center provides companies with the raw material they need to develop commercial applications.

That's how the fibronectin research of Hakomori wound up in the hands of the fledgling Adeza Biomedical Corporation. After the Hutchinson Center obtained a patent and awarded Adeza a license, the company created FullTerm, The Fetal Fibronectin Test. With a half million tests administered annually, FullTerm is one of the most successful examples of how Center research serves as a springboard for creating products while at the same time generating royalty payments to support future research.

Based in Sunnyvale, Calif., Adeza was a women's health-care company that had yet to develop a product when its leaders came across Hakomori's fibronectin research. Hakomori's research had continued to advance and he had made a related discovery. Still investigating the cause of metastasis, he found that fibronectin in cancer cells is different than fibronectin in normal cells — a difference that gives scientists another potential way to target cancer cells for treatment.

Putting fibronectin to the test

But that's not what caught Adeza's eye. In the process of discovering that the fibronectin in cancer cells is different from normal cells, Hakomori discovered that fetal-cell fibronectin demonstrated the same difference as cancer-cell fibronectin (the shared term for this deviation is oncofetal fibronectin). That meant it would be possible to identify the presence of fetal fibronectin in a mother's system — a telltale sign of impending birth.

Fetal fibronectin helps bind a baby to the womb, said Mark Fischer-Colbrie, chief financial officer at Adeza. As birth nears, fetal fibronectin begins to slough away and enters the mother's circulatory system. Normally, that would occur late in pregnancy. If this sloughing away occurs between weeks 22 and 35, it's a red flag.

In the past, doctors had no good way to determine whether a woman was at imminent risk of giving premature birth, Fischer-Colbrie said. If a woman was experiencing early contractions, had previously given premature birth or displayed some other symptom, a doctor's best option was to error on the side of caution and prescribe medication and/or bed rest.

'An impressive success story'

By testing for fetal fibronectin in a mother's cervico-vaginal excretions, FullTerm can confirm the risk of a premature birth. As a result, doctors can avoid prescribing needless treatment if tests are negative or provide proper treatment if they're positive. If necessary, results can be available almost immediately.

Adeza launched FullTerm in 1999. Buoyed by the test's success, Adeza became profitable in 2002, went public in 2004 and expects to report revenues of $51 million to $53 million this year — 95 percent of which stems from FullTerm sales, Fischer-Colbrie said. Now the company is pursuing three other potential applications involving fetal fibronectin: a test to determine whether labor should be induced, a test to predict delivery dates and a test to detect bladder cancer. In addition, Adeza is pursuing Federal Drug Administration approval of a therapy that prevents pre-term births.

"It's an impressive success story," Lemons said. It's also a powerful example of how Hutchinson Center research inspires ongoing waves of medical advances.

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