Complex genetic tests—without the complexity

For personalized medicine to take hold, the genetic testing market must undergo dramatic technological and economic changes. These changes are necessary to switch the market from simple, single-target tests to highly complex, multi-target tests necessary for accurate disease identification and prognostication. These tests will provide greater amounts of actionable information about disease state and progression at a significantly lower cost, enabling doctors to make more precise and effective therapy decisions.

The last decade has seen the development of tests that can be used to improve the diagnosis of disease, guide therapy decisions in cancer, and predict unfavorable drug reactions. Despite the immense promise, the challenge still exists for how to validate and integrate these breakthrough diagnostic tests into patient care. The routine incorporation of genetic testing into patient care requires that the tests be delivered quickly, simply, and cost-effectively at the point of care. DxTerity can meet this significant unmet need with its NEAT™-enabled automated genetic tests.

Genetic testing today

Genetic testing in the United States today is an approximately $3 billion market with testing conducted primarily in commercial reference labs. With the recent introduction of the first automated platforms for low-complexity gene tests into hospitals, genetic testing is beginning to migrate into an environment where it can become a routine part of medical care. However, this is true only for low-complexity tests. High-complexity tests, which test dozens of genes, currently require days or weeks to obtain an answer. As a result, the clinical utility of the tests is greatly diminished.

As new technologies that allow these more complex genetic tests to be run quickly and cost-effectively are commercialized, genetic testing will migrate from the reference lab to the doctor’s office. As a result, the United States genetic testing market is expected to grow rapidly to approximately $12 billion by 2017.

Genetic testing: part of the cure

By enabling complex gene signatures to be run at the point of care on a simple-to-use, quick, and affordable platform, DxTerity can help drive genomic market growth. This will allow practitioners, for the first time, to have a complete individualized patient assessment prior to prescribing a treatment for many of the major disease states that affect millions of people worldwide and consume many of our healthcare resources.

Molecular diagnostics growth to point of care depends upon:

  • Ability to multiplex complex signatures
  • Test turnaround time
  • Ease of use
  • Reasonable cost

NEAT: a new pathway to clinical use

DxTerity Diagnostics’ NEAT platform will provide a new pathway to clinical use for companies with genetic signatures. By providing a validation platform for proving signatures that can scale directly to a simple end-point test, DxTerity provides reduced risk and faster time-to-market for genetic signatures. DxTerity plans to populate NEAT-based, highly automated, FDA-cleared platforms in thousands of hospitals, clinics, and emergency response installations across the United States, giving signature holders a cost-effective delivery channel to market their tests.

These developments provide gene signature test holders with a well-defined pathway from development to volume delivery of tests and a more cost-effective and rapid market entry.

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