One of Spokane’s fastest growing technology companies, Signature Genomic Laboratories, is about to take on the next big challenge in medical testing: devising a way to use human DNA to detect genetic changes associated with cancer.
If successful, the test developed at the company’s north Spokane lab will likely change how doctors diagnose cancer. Instead of using any number of tests that each identify a single type of cancer, the Signature Genomic method would scan a person’s full set of chromosomes – the genome – and find all possible DNA signatures tied to many cancers.
DNA is the genetic building block making up the 46 chromosomes found in nearly every human cell. The growth seen at Signature Genomic reflects the company’s use of tools that can analyze human DNA and identify medical disorders quickly and more accurately than older methods.
Since CEO Lisa Shaffer and Medical Director Dr. Bassem Bejjani founded the company in 2003, Signature Genomic has pulled ahead of the pack in the fast-changing and competitive area of medical cytogenetic testing, industry observers say.
Cytogenetic tests, which examine the structure of human chromosomes, allow doctors and clinics to test for more than 200 genetic syndromes, many quite rare and most involving a form of mental retardation. Some conditions are apparent at birth, others not until later in childhood.
The company’s success has been impressive, say observers. In 2005 it had about a dozen Spokane workers. Today it has more than 115 at its north Spokane complex.
One of the company’s major investors, Evan Jones, sees even stronger growth if Signature continues moving forward with the cancer test product.
Jones, chairman of the private company’s board, joined the company in 2008, investing an undisclosed amount of money in exchange for roughly a 10 percent stake in Signature.
He’s spent 25 years developing life science and biotech companies. His major accomplishment, as CEO of diagnostic medical firm Digene, was turning it into a successful public company later bought for $1.6 billion by a Dutch corporation.
After that, Jones launched jVen Capital, a venture investment firm based in Potomac, Md.
Originally skeptical that the company could develop a cancer screening tool, Jones said he’s now confident that Shaffer, Bejjani and the team will succeed.
“What convinced me is that there are very special people working at Signature Genomic,” he said.
“I’ve come to appreciate the community of geneticists in Spokane, growing around Signature Genomic. That group is in the right place at the right time,” Jones said.
Success and growth
Bejjani and Shaffer were first recruited to Spokane from the Baylor College of Medicine by Sacred Heart Medical Center and by Washington State University.
During a recent tour of the company’s north Spokane building, Shaffer said the company’s fast success has surprised her as well. For 2008, she projected Signature would provide about 5,000 commercial medical tests. The total was closer to 14,000 tests.
During the firm’s first five years the strategy was to build on the technology used by doctors and clinics to identify genetic conditions, Shaffer said.
“It was a natural extension for us, as cytogeneticists, to take what we built and apply it to chromosome changes associated with cancer,” she said.
Even so, developing DNA-based cancer testing technology is difficult, Jones said. Beyond the challenges of creating accurate tools is the added complexity of gaining approval from the U.S. Food and Drug Administration for an entirely new medical method, he said.
“No one has ever done it before, and there are others trying to do it. But we are going to be in the lead from a technology point of view,” Jones said.
Shaffer said the initial cancer tests Signature has developed target blood disorders such as leukemia and lymphoma. Validation testing has been conducted over the past several months.
She knows the company can expect competition, including the university labs that up to now had been sending test samples to Spokane. Those labs are buying similar testing tools to try those tests in-house.
These advanced tests are all ordered by physicians or specialized geneticists, not patients.
Interest in advanced prenatal and pediatric testing is growing. For now Signature Genomic has about 1,000 clinicians and medical centers using its services. Most of its work comes from within the U.S., but the company sees a growing interest from overseas clinics and doctors, Shaffer said.
Each test costs from $1,400 to $2,000. Most patients use medical insurance to pay for them.
Signature was the first approved lab to offer commercial microarray CGH (comparative genomic hybridization) tests.
Microarrays are carefully packed glass slides with thousands of dots of DNA arranged on the surface. After sample DNA is mixed and applied to the slides, computer chips analyze whether the chromosomes reveal aberrations at key points in the person’s genetic material. A duplicated chunk of genetic material, or a deleted section of a DNA sequence, typically indicates a specific disorder, such as Down syndrome.
The standard microarray CGH test looks for deleted or duplicated genes. But the new cancer tests have to look for a different target. “Many cancers are associated with very balanced translocations (of a genetic sequence on the chromosome),” Shaffer said. “All the DNA is there, but it is just rearranged.”
The goal for the cancer tool is to help doctors diagnose cancer more quickly. The one downside, so far, is that the tool will not find instances of relatively small numbers of cancer cells in a specimen. It will only detect a cancer if the abnormality is in at least 30 percent of cells in the specimen.
Jones said he comes to Spokane once a month to discuss business with the Signature Genomic team. He laughs when he recalls his initial reaction when he listened to Shaffer and Bejjani at an investors’ presentation in 2007. He liked what he heard but decided not to invest then.
“It was too far away for me. I didn’t want to travel that far,” Jones said.
But he continued doing research in the area of genetic medicine and concluded that Signature Genomic was a potentially significant player. Within a year he invested in the firm and joined the board.
“The team they’ve put together had done a wonderful job building the company to where it is,” Jones said.
He’s convinced the team will continue playing a part in the 21st century genetic revolution in medical care, and that its technology and talent will remain based in Spokane.
It’s possible another large company would try to buy the firm, but Jones insists that wouldn’t mean the company would relocate.
“It’s hard to move the core expertise and science base of this company,” he said. “I’m confident they will stay right there in Spokane.”