November 16, 2007 in Business

Biomedical success

By The Spokesman-Review
 
Christopher Anderson photo

Blake Ballif is framed in the cover of one of the automated machines used by Signature Genomic Laboratories.
(Full-size photo)

How it works

» The testing process begins when Signature Genomic employees, who work behind locked doors, receive vials of patients’ blood and use automated equipment to extract DNA. Other technicians stain patient and control DNA with fluorescent dye and place it on glass slides. Pieces of both sets of genetic material compete to match with spots on the “microarrays.”

» After the material incubates overnight, slides are washed to remove the excess. In a darkened room, employees use laser scanners and proprietary computer software to analyze the intensity of the dyed material. Software displays discrepancies visually.

» If analysts find abnormalities, the company does a final, more specific, test to take a closer look.

Four years ago, Signature Genomic Laboratories LLC had three employees, a 1,200-square-foot lab at a Spokane hospital and a new type of test for diagnosing children with genetic abnormalities that cause birth defects or developmental disabilities.

Now the swiftly growing Spokane biomedical firm employs 54. It’s preparing to move into its own 18,444-square-foot building in north Spokane. And it expects revenues of $12 million, a $3 million increase from last year, said CEO and co-founder Lisa Shaffer.

“We’re moving from childhood into adulthood now, and we skipped through adolescence,” said Bassem Bejjani, co-founder and medical director.

Signature has outgrown its current space in a lab building run by tech-business incubator Sirti, Shaffer said. It purchased and is renovating a former Sears, Roebuck and Co. repair center, at 2820 N. Astor St., for $3.8 million, and it expects to move this April.

“We were the first to do mircroarray-based cytogenetic testing – and we continue to be the leader,” Shaffer said. “We did a market survey in June, and we have the largest market share from the people who were surveyed.”

Signature recently was named technology “Company of the Year” for 2007 at the annual, regional Catalyst Awards, presented by Greater Spokane Inc.

The company’s test compares microscopic segments of patient DNA with control DNA, looking for gains or losses of genetic material. The newest and fifth version of its test spans more than 150 syndromes with more than 4,724 segments of DNA – more than 20 percent of the human genome, according to Signature.

A previous test, called FISH, examined more specific genetic regions, so doctors had to have an idea what they were looking for, said Blake Ballif, director of product development and research.

While older tests took a minimum of 10 days, the Signature test takes just a couple, according to the company.

“We also look for some very, very rare things, because we want to be able to provide the most information possible to patients,” Shaffer said. “A lot of times they’re sent to us because the clinician doesn’t know what the child has, so they want the test that can look at the whole genome.”

While Signature primarily tests children 4 or younger, it also does prenatal tests and checks some adults, including those considering conceiving.

The company expects to process more than 10,000 cases this year, up from 7,500 last year, Shaffer said. Signature claims it has made more than 2,000 clinical diagnoses.

“Even if it doesn’t cure everything, it gives families information, and that’s empowering,” said Justine Coppinger, lead genetic counselor. “From my perspective, it’s the greatest job in the world, because most of the time we’re finding the answer to that patient’s set of problems and how a physician can treat them.”

Tests cost $1,650.

“To put it in perspective, when patients spend a lifetime getting tests, getting painful procedures sometimes like a muscle biopsy, a skin biopsy, going under anesthesia to get an MRI of the brain, the costs are huge compared to this one-time cost that will give you a diagnosis,” Bejjani said.

Signature has two patents pending review on its microarray designs and methods, the founders said. It also has submitted a patent describing how to detect two new genetic syndromes Signature has discovered.

Competition has sprung up, and rivals don’t necessarily share Signature’s philosophy that people shouldn’t own genes, Bejjani said.

“We want to protect ourselves to have the freedom, once we discover something, to test for it,” he said.

The company currently sells its microarrays and use of its software to other companies for research purposes, but it must obtain U.S. Food and Drug Administration approval before it can sell them for clinical purposes – a company goal, Shaffer said.

Signature uses robotic machinery to manufacture samples in-house. Once remodeled, the building is slated to include a clean room and an ozone-free room, Shaffer said.

To keep the male and female control DNA samples consistent, Bejjani and Shaffer use their own blood. They donate about once every other month, Shaffer said.

Bejjani foresees expanding Signature’s range of microarray testing and looking at different technology. Signature continues to invest in research and development, he said.

The founders, then professors at Baylor College of Medicine in Texas, in 2002 moved to Spokane after being told by their chairman that using microarrays as they envisioned would be impossible, they said.

Next year, the company anticipates employing 75 and posting more than $20 million in revenue.

Bejjani said Signature has changed the way the rest of the world looks at chromosomes.

“Cytogenetic testing remained stagnant for a long time, and we believe that we started this revolution here in Spokane,” he said.


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