Should doctors insist on a genetic test for each patient before prescribing a new drug? They don’t today, but if a new generation of low-cost, easy-to-use gene testing systems comes to market, such tests could become standard fare.
There are already a number of companies in the Puget Sound region selling products that combine laboratories and information technology to offer the potential for improved health care, including Bothell-based Iverson Genetics, Seattle-based Genelex, and Natural Molecular Testing Corp. of Renton. Meanwhile, Stratos Genomics of Seattle is focusing on ways to sequence genes more cheaply while Seattle-based Spiral Genetics is offering a service to improve the way in which genetic information is stored and processed.
Iverson Genetics shows both the promise and the gamble involved in this market. It is a genetic sequencing and information technology company that sells a program to help doctors or hospitals interpret the results of those tests. CEO Dean Sproles says Iverson’s products and services will vastly expand the use of genetic testing by making results easier to read and interpret.
“What we are providing with Physicians Logic [proprietary software] is an easier operating system—the Windows of genetic medicine,” says Sproles.
One of Iverson’s genetic tests can be used by doctors before they prescribe a blood thinner to a patient. It is well-documented that patients differ in their responses to Warfarin, which is among the most commonly prescribed drugs in the United States. Adverse reactions to drugs are listed as one of the top 10 causes of death in the country, and genetic testing can identify some patients who would respond atypically to Warfarin. The hope is that doctors can prevent adverse reactions by filtering patients based on genetic information.
Genelex and Natural Molecular Testing also sell a variety of gene-testing products. Genelex has its own version of a Warfarin test and sells software to create a better user experience for health care professionals.
Whether the market will embrace these products and services is still unclear. While there are 1.9 million hospitalizations annually due to medication side effects or errors, many are not because of genetic differences but because patients don’t follow directions or there are dosing errors. The Center for Medicare and Medicaid Services (CMMS) has a nationwide clinical trial under way using the Iverson test to try to determine its clinical effectiveness. Seattle’s Group Health Research Institute will soon begin a study of the effectiveness of such tests. Meanwhile, the institute’s director, Eric Larson, remains skeptical.
“So far, the gain [in health] from genetic information has not been as dramatic as we would all like it to be,” he notes. While he recognizes that, over time, genetic tests may make a significant difference, developing such tests and proving their effectiveness could take a long time.
The Seattle area has a long history of innovation in sequencing and genomics. Leroy Hood, who helped design the first machines that sequenced DNA while he was at California Institute of Technology, moved to the University of Washington and later created the Institute for Systems Biology in Seattle, where Sproles once worked. Sproles started Iverson in 2007, and Hood is on Iverson’s advisory board. Hood believes that a greater understanding of the genetic makeup of individuals will result in huge improvements in health care.
But the health care system has been slow to adopt “personalized medicine,” as the approach is often called. One challenge is that it’s often unclear whether health care providers will be reimbursed for such tests. And many physicians remain doubtful about the tests’ effectiveness.
Another Seattle spinoff from the Institute for Systems Biology is NanoString Technologies, which announced in September that it would seek European approval to sell a testing system for breast cancer that shows what is known as a “gene expression analysis.” According to a recent story in the online magazine Xconomy, CEO Brad Gray predicted NanoString would also seek approval from the U.S. Food and Drug Administration in 2013.
An additional challenge to adoption of personalized medicine is the high cost. New technology could quickly drive down some of those costs. Stratos Genomics, which has about 15 employees and is housed inside of Seattle-based Stratos Product Development, believes it has developed a machine for reading an individual’s genetic makeup more quickly and less expensively.
Allan Stephan, founder and CEO of Stratos Genomics, says the system, called Sequencing by Expansion, first expands the DNA molecule (made up of about 3 million base pairs) and then threads it through what is called a nanopore that reads the sequence. Two of Stratos’ competitors in this space are Oxford Nanopore Technologies in England and Ion Torrent of Guilford, Connecticut, and San Francisco.
Spiral Genetics, by contrast, has developed a service that makes it easier to store, access and analyze genomic information. CEO Adina Mangubat admits that the field of genetic sequencing is littered with bold claims that have not panned out, but she thinks she can help the prospects of the entire industry by allowing researchers to analyze more genetic data and understand its impact faster.
For all the skepticism about the promise of genetics research, few doubt the sector will have a huge impact over the longer term. But at this early stage, it’s far from certain what companies will survive and thrive. Makers of genetic tests and equipment think they are in the right part of the business. As Allan Stephan of Stratos says: “During a gold rush, you want to be selling tools.”