June 2007 Clinical Laboratory News: News From the FDA

June 2007: Volume 33, Number 6

Guidance on Breast Cancer Assays
First Following IVDMIA Announcement

Just three months after clearing the MammaPrint test, the FDA kept its promise to offer greater direction on such assays, releasing a new guidance document classifying multi-gene, algorithm-based prognostic tests for breast cancer as class II devices.

For manufactures, this means fewer regulatory requirements to bring a test to market than the higher class III level. But as the first guidance document that focuses on a multi-gene, algorithm-based test system—branded IVDMIAs by the FDA—the new guidance may give stakeholders a glimpse of how the FDA is thinking.

The new guidance “should indicate that FDA will continue to review submissions of all types (including expression arrays) in a risk-based manner using flexible review tools that allow for timely and transparent work processes,” said Steve Gutman, MD, Director of OIVD. The FDA is still in the process of reviewing comments on the controversial IVDMIA draft guidance, which the agency has had since March 5.

The new guidance document, “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis,” is available on the Web.

FDA Clears Two Roche Assays

Roche Diagnostics (Indianapolis, Ind.) announced the FDA clearance of its 9-minute STAT Parathyroid Hormone (PTH) test on the Elecsys 1010 and 2010 systems and Cobas e 411 analyzer. The assay is the only STAT PTH test on an automated immunoassay platform. Designed for quantitative determination of intact parathyroid hormone, the immunoassay allows differential diagnosis of hypercalcemia and hpyocalcemia from serum and plasma.

The FDA also cleared the Roche D-Dimer assay for an expanded claim to exclude, or rule out, deep vein thrombosis (DVT) and pulmonary embolism (PE) when used in combination with a non-high clinical probability score. It is the first D-dimer test to offer the exclusion claim on a fully automated clinical chemistry analyzer that allows consolidation of D-dimer testing with routine testing.

Final Guidance Relaxes Rules on HSV Tests

In a final guidance, the FDA reclassified herpes simplex virus serological assays from class III into class II, lowering the regulatory hurdle for these tests. Tests classified under class II require only a 510(k) premarket notification, in which the manufacturer demonstrates that its product is similar to those already on the market and is less burdensome for the manufacturer. The guidance, “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays,” is available online.

Direct Enzymatic HbA1c Assay Cleared

Diazyme (San Diego, Calif.) announced the FDA clearance of its Direct Enzymatic HbA1c Assay kit for the qualitative determination of HbA1c in whole-blood samples. The test uses two ready-to-use, liquid-stable reagents. It does not require a separate measurement of total hemoglobin content; therefore, the assay only needs a single channel to perform the test on chemistry analyzers. Results are directly reported as percent of HbA1c.

MRSA Test Cleared

Cepheid announced the FDA clearance of its Xpert MRSA assay for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA). The Xpert MRSA test is designed for use on the GeneXpert system and provides results in about an hour. According to the CDC, MRSA is the leading cause of hospital-acquired infections.
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