Medical Device Link.

Originally Published IVD Technology July 2003

INDUSTRY NEWS

Diagnostic Device Evaluation and Safety (OIVD), FDA’s Center for Devices and Radiological Health (CDRH) is gearing up for a flood of new submissions from the IVD sector.

Speaking in June at the annual meeting of the Medical Device Manufacturers Association (MDMA; Washington, DC), center director David Feigal noted that the unique characteristics of the IVD sector made creation of OIVD essential. “We couldn’t go on conducting business as usual,” said Fiegal. “This is an area that needs to reinvent itself by creating its own logical scheme for premarket and postmarket reviews, and so on.”

Feigal indicated that the agency restructuring was also necessary to build scientific expertise in anticipation of growth in the field. “As a result of the Human Genome Project, we expect to receive more diagnostics submissions in the next 5 years than we have seen in the past 20 years,” he said. 
Noting that OIVD is “aware of its external environment”—including the coming requirements of the European Union’s IVD Directive—Feigal added that “we need to participate” in the development of reference standards called for by the directive.

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In its updated recommendations on genetic testing for cancer susceptibility, the American Society of Clinical Oncology (ASCO; Alexandria, VA) advocates the strengthening of regulatory oversight of laboratories that provide clinical cancer predisposition tests. ASCO also calls for the improvement of quality assurance mechanisms to include oversight of the reagents used in genetic testing, interlaboratory comparisons of reference samples, standardization of laboratory genetic test reports, and proficiency testing.

Recognizing the importance of financial resources in facilitating such testing, the society also states that it “supports efforts to ensure that individuals at increased risk of hereditary cancer have access to appropriate genetic testing, screening, and surveillance and that these services should be covered by public and private third-party payers.” The abstract and a link to the full guidance are available on-line at http://www.jco.org/cgi/content/abstract/21/12/2397. 

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Analysts at an IBC Life Sciences (London) conference predicted that current reimbursement systems would not be well suited for molecular diagnostics and personalized medicine. Molecular diagnostic test developers are likely to face several difficulties in securing reimbursement for their tests. The systems are centered on the precept of standardized medicine, and were not designed to address individualized coverage, coding, and payment based on personalized medicine. 

The Centers for Medicare and Medicaid Services (CMS; Baltimore) may decline to provide reimbursement for molecular diagnostic tests that estimate a patient’s ability to metabolize and response to drugs, since Medicare does not offer prescription drug coverage.
CMS will also have to assure that genetic tests are clearly diagnostic and not screening tests in order to guarantee reimbursement. Diagnostics looking for genes or mutations that are disease “risk factors” are considered screening tests and would not be reimbursed in every case.
An additional hurdle for molecular diagnostic manufacturers is that expensive molecular diagnostics may fall under existing codes with far lower payment rates than are sufficient to cover the cost of the test.

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FDA’s Center for Devices and Radiological Health (CDRH; Rockville, MD) may draft a separate guidance focusing on quality system regulations (QSR) and good manufacturing practices (GMP) for multiplex tests and microarrays in addition to its recently released draft guidance “Multiplex Tests for Heritable DNA Markers, Mutations, and Expression Patterns.” Regulatory issues such as product bundling and study design will probably be settled at pre-IDE meetings, and a more thorough explanation of IVD bundling will be presented in FDA’s impending guidance. However, the center is particularly interested in addressing issues related to QSR/GMP. 

CDRH would like to learn whether industry feels that a separate QSR/GMP guidance is needed. It has requested feedback on array and data processing, namely how manufacturers are optimizing their multiple simultaneous target detection. In addition, the center has noted that the algorithms being used for data processing are constantly changing, and the statistical methods employed differ, depending on the type of device under analysis. Comments conveying manufacturers’ experience with such analytical methods should be submitted to the center for consideration. CDRH is also willing to accept volunteers to write a draft guidance addressing concerns over QSR/GMP for multiplex tests and microarrays.

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Greater FDA oversight of genetic test labeling may pose a solution to problems related to underinformed or misinformed patients. Patients tested for cystic fibrosis (CF) via screening for the 5T polymorphism who then terminated pregnancies due to the presence of the 5T variant alone have raised concerns. In the absence of its accompanying CF-related mutations, the 5T variant is not correlated with increased risk of CF. 

At a meeting coordinated by Johns Hopkins’ Genetics and Public Policy Center (GPPC; Washington, DC), suspicions that inadequate education for both patients and practitioners may be endemic for genetic testing prompted the submission of several proposed solutions. Looking to the ASR rule as a precedent, suggestions were made to rely on the labeling of genetic tests as a resource for communication to the provider. In addition, more-strict oversight of the tests themselves was proposed. Payers’ refusal to reimburse for testing that breaches recommended guidelines might provide another solution. However, meeting panelists noted that genetics testing issues are so complex that both further clarification of existing guidelines and quantification of the extent of the problems stemming from improper testing should be accomplished before further measures are put in place. The full text of the GPPC statement can be accessed on-line at http://www.dnapolicy.org/pdfs/CF2statement.pdf.  

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