Diagnostics

ECRI wants to bring transparency to molecular diagnostics, an arena plagued by useless tests

There are many thousands of genetic tests out there but many of them are useful for research purposes and aren't clinically relevant.

A doctor takes blood from a patient (Photo: Getty Images/ Adam Berry)

A doctor takes blood from a patient (Photo: Getty Images/ Adam Berry)

Less than 5 percent of molecular diagnostic tests are clinically relevant, says Diane Robertson, director of health technology assessment at the ECRI Institute, a non-profit organized devoted to assessing medical technology.

“With 60,000 genetic tests ‘out there’ and a landscape that changes day to day, payers and hospitals have a huge challenge to keep up with the landscape of the tests available, what those tests do, who makes and performs the test, how the tests inform (or not) patient management, and which have evidence to support their clinical use,” she wrote in emailed response to questions.

To help hospitals and other stakeholders filter through the noise and hype, the Institute just launched a database of genetic tests dubbed Ecrigene. It contains the tests’ descriptions, indications of use, regulatory status, reimbursement information, and links to evidence reports prepared by the institute.

Even the database can’t keep track of all 60,000 tests. A proprietary methodology was used to determine which diagnostics to include. “The ones that matter are typically problematic, controversial, complex, and aggressively marketed to consumers,” says the ECRI institute in a release.

According to Robertson, stakeholders of all sorts are interested and will pay for the membership-based service. “Payers want to understand what tests are in clinical use and what the tests purport to do so coverage policies can be established and updated. Hospitals are interested because they have a problem of inappropriate ordering of tests due to lack of sufficient knowledge about what tests are out there and what their clinical validity and clinical utility is, and when it’s appropriate to order. For manufacturers, the database is a landscape of the tests that can inform what competes with their tests or complements their product,” she said in the email.

While the ECRI institute looks to fill the void of disaggregated, often low quality information, the feds are scrambling to police the burgeoning pool of molecular diagnostics so that unhelpful (and sometimes dishonestly marketed) tests are weeded out.

Right now the FDA only regulates makers of diagnostics testing equipment, while tests that are performed in centralized laboratories do not have to prove clinical relevance to the government. The agency is aiming to bring all tests under its regulatory umbrella, but its plan to do that has not been finalized, perhaps because of opposition by the American Clinical Laboratory Association, which has been lawyering up since the regulation was drafted in October 2014.

The Centers for Medicare & Medicaid Services is also struggling to evaluate the plethora of diagnostics to determine whether they are worthy of Medicare and Medicaid reimbursement. In addition to being accurate, the tests should provide information that will impact clinical physician decision making and change the course of care (ie, be clinically relevant), the agency says, echoing the view of others.

“In other words, just because one can test for a certain gene or panel genes does not mean that it will be helpful for patients,” Robertson said in the email. “Many genetic tests are useful for research purposes only—which means their utility isn’t clear and they are not clinically relevant,” she added.

To stay on top of the ever changing field of molecular diagnostics, the ECRI institute is deploying a team of medical librarians and has a “protocol for identifying new tests, searching for evidence, identifying new information on existing tests, and inputting new information daily to the database,” according to Robertson.

Hopefully, Ecrigene works, because more transparency is sorely needed in molecular diagnostics. Just consider the sad state of Theranos, or if you are uninitiated to the fiasco, wait for the upcoming movie about Elizabeth Holmes, to be played by Jenifer Lawrence.

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