IDSA seeks pathway to better diagnostic tests

Saying physicians too often must make treatment decisions with inadequate information, the Infectious Diseases Society of America (IDSA) issued recommendations today designed to spur the development of better diagnostic tests and encourage their use.

Better tests are needed not only to improve treatment decisions, but also to preserve the effectiveness of antibiotics and enhance the response to disease outbreaks, the IDSA said in releasing its report in Clinical Infectious Diseases.

The society called for steps to increase funding for development of tests, smooth the regulatory pathway for them, and make it easier for biotechnology companies to obtain clinical specimens for use in test development, among other things.

Angela M. Caliendo, MD, PhD, lead author of the IDSA report, cited acute respiratory infections as a prime example of a condition for which better tests are needed.

Speaking at a press teleconference yesterday, she said that when a patient comes to an emergency department with a fever, cough, and shortness of breath, it would be very helpful to have a test to tell if the infection is bacterial or viral. She is executive vice chair of the Department of Medicine at the Warren Alpert Medical School at Brown University.

Faster tests wanted

She stressed the need for faster tests: "In order for us to use these tests routinely, they must be simple to use, inexpensive, and rapid. We're talking about a result in an hour. Currently clinicians can wait hours to even days for some results that influence their management decisions. We often prescribe antibiotics or antivirals even in situations where they might not be necessary."

Half of patients who see doctors for upper respiratory infections receive antibiotics, even though most such infections are viral and thus not treatable with antibiotics, the IDSA noted in a press release. It said there is no test that can easily and inexpensively help doctors identify the cause of such infections.

Improved tests would also help doctors and public health officials to quickly identify emerging infections, assess the spread of diseases like malaria, measles, and dengue, detect and track foodborne illnesses, and respond more effectively to outbreaks, the IDSA said.

Caliendo said encephalitis is another condition for which better tests are sorely needed, since antiviral medications are indicated for some forms but not for others.

The IDSA recommendations fall into four general areas: (1) financial incentives and regulatory streamlining; (2) improved clinical research infrastructure; (3) funding for outcomes research; and (4) appropriate reimbursement, additional infrastructure, and education.

Appealing for more dollars

The IDSA leads off its extensive set of recommendations by calling on the National Institutes of Health to increase funding of diagnostic research, especially through the Small Business Innovation Research Program and the U01 funding mechanism, which pertains to research project cooperative agreements.

The group also calls for establishing "biorepositories or other infrastructure" to ease the procurement of clinical specimens needed to validate novel diagnostic tests.

"To facilitate the regulatory process it would be helpful to have a bank of specimens that were well defined and available to both researchers and companies to assess the performance of tests and ensure they provide accurate results," said Caliendo. An example of such specimens would be nasal swabs from people known to have flu and others known not to have it.

The report also calls on Congress to increase funding for diagnostics development by the Biomedical Advanced Research and Development Agency and for the Centers for Disease Control and Prevention's Advanced Molecular Detection Initiative, which aims to improve technology for public health surveillance.

Lowering regulatory hurdles

If more federal funding isn't possible in today's budgetary climate, at least reducing the regulatory burden on companies that develop diagnostics should help, said Caliendo.

"For years now in the diagnostic world, we've relied heavily on companies to support research and development of these tests," she said. "I think we're going to have to find ways to relieve the financial burden on companies. . . . If Congress isn't going to invest [in development], then we need to turn to the regulatory phase and see if we can reduce the regulatory burden to make it more feasible for companies to get tests through [the approval process]."

The US diagnostics industry spends 35% of overall revenue on research and development, according to an estimate from AdvaMedDx, a diagnostics trade association. The group said that compares with an overall US industry average of 3.3%.

Caliendo said the Food and Drug Administration (FDA) has already taken some steps in this direction. An example in the influenza realm is allowing the use of "spiked specimens," or specimens to which flu virus has been added, for validating flu tests. She said that approach is helpful because naturally infected clinical specimens are hard to get.

The IDSA also is calling for the continued use of "de-identified residual clinical specimens" for diagnostic development. The group wants the Department of Health and Human Services to drop a proposal for a new informed-consent requirement for research with such samples, which was released in 2011.

Another suggestion is that the FDA use its authority to "exempt companies from redemonstrating the clinical validity of a novel diagnostic product after multiple studies for similar products have been conducted."

Here are a few of the many other IDSA recommendations:

  • The Center for Medicare and Medicaid Services (CMS) should eliminate the wide regional differences in reimbursements for diagnostic testing and ensure the reimbursements cover the cost of testing.
  • To provide labs with greater clarity about the process for clinically validating new tests, CMS should work to harmonize recommendations under the Clinical Laboratory Improvement Amendments with those from professional societies.
  • The federal Agency for Healthcare Research and Quality and the Healthcare Resources and Services Administration should fund and encourage healthcare institutions and societies to inform physicians about the utility of available tests and the results of diagnostics research.

See also:

Nov 7 IDSA press release

Nov 7 Clin Infect Dis report landing page

Full text of IDSA report

AdvaMedDx fact sheet with figures on R&D spending

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