Signature Genomics-developed test is first of its kind to use microarrays
A year after it was acquired by a Boston corporation, Spokane genetic testing company Signature Genomics Laboratories is expecting strong growth for its newest product, a cancer-screening test. But it may take awhile.
As it did in 2004 when introducing the first microarray-based test for detecting DNA alterations in fetuses and newborns, Signature Genomics finds itself at a disadvantage by being first out of the gate doing something similar for detecting major changes in human chromosomes related to cancers.
Its novel cancer-screening tests, commercially branded as OncoChip, have not been on the market long enough to be recognized as a clinical test.
The result is that many insurance companies won’t cover the cost of OncoChip tests, which range from $1,500 to $2,000.
Launched in January, the OncoChip tests provide clinics and oncologists with a precise method of looking for changes in human genetic material, or DNA.
While OncoChip’s uptake is still at the early stage, the company expects the new lab test will gain ground over time, said Dr. Lisa Shaffer, president of the North Spokane company.
Demand for OncoChip testing will grow over time, as happened with prenatal testing, as clinicians and scientists validate its clinical potential, Shaffer predicted.
“We’re gaining momentum in the market,” Shaffer said. “Everyone believes in the technology.”
In May 2010, Boston-based PerkinElmer purchased Signature Genomics, which Shaffer started with fellow researcher Dr. Bassem Bejjani in 2003. Bejjani has since left the company.
Publicly traded PerkinElmer made the purchase in part because Signature Genomics was the first diagnostic laboratory to provide microarray-based diagnostic tests for mental retardation and birth defects.
Microarrays are sheets that contain thousands of human genes, which are tested for alterations in DNA. A key advantage of the OncoChip test is providing the same results that clinics now get through two separate standard tests that look for changes in human genes, Shaffer said.
The specialists and clinics that now are ordering OncoChip tests find they’re puzzled by a patient with a cancer diagnosis but whose DNA tests fail to reveal the expected genetic changes or alterations associated with that disease, she said.
Signature’s technology allows clinicians or oncologists the ability to find those “cryptic” genetic alterations or translocations – a switch of DNA segment from one chromosome to another – that can’t be seen through microscopes, Shaffer added.
The OncoChip test, at present, has been marketed for diagnosis of leukemias and lymphomas, Shaffer said. The goal is to broaden the number of cancers that can be tested.
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