March 2007 Clinical Laboratory News: News From the FDA

March 2007: Volume 33, Number 3

Breast Cancer Recurrence Assay Becomes First Cleared IVDMIA
Agendia (Amsterdam, The Netherlands) announced the FDA clearance of a test that predicts the likelihood that a woman’s breast cancer will metastasize and return within 5–10 years after her initial diagnosis. The first in vitro diagnostic multivariate index assay (IVDMIA) to receive FDA clearance, the MammaPrint assay measures the level of expression of 70 genes. A special algorithm then produces a score indicating whether the patient is at low risk or high risk for a return of her cancer. Together with other clinical information and laboratory tests, results of the assay can help physicians decide on follow-up treatment for patients. The assay has been on the market in The Netherlands since 2005. In a press release announcing clearance of the MammaPrint, FDA said it plans to publish a special controls guidance document describing types of data that should support claims for genetic profiling for breast cancer prognosis.
FDA Panel Cautious on Clinical Value of Lipoprotein Subfraction Assays 
At a December meeting, the FDA Clinical Chemistry and Clinical Toxicology Devices Panel concluded that until accuracy and other analytical issues are properly addressed, lipoprotein subfraction assays should be used only to supplement traditional CVD risk assessment tools. However, the panel did not go so far as to suggest that the assays did currently not have clinical value. In general, the panel felt that the assays could be useful for testing certain patient populations. But members cautioned that until reference ranges and standards are developed, the assays are best used in conjunction with traditional assessment tools that are already well established and fully understood. The summary of the meeting is available at the Food and Drug Administration website.
FDA Clears First Assay for Mesothelioma
Fujirebio (Malvern, Pa.) announced FDA approval of its MESOMARK assay, the first in vitro diagnostic test for mesothelioma, a cancer linked to asbestos exposure. The blood test allows physicians to monitor patients diagnosed with biphasic or epithelioid forms of the disease, both for recurrence following surgery and for measuring response to therapies. The assay measures levels of the biomarker mesothelin in serum, and results correlate with the patient’s tumor volume. The FDA approved the MESOMARK assay under its Humanitarian Device Exemption (HDE) program, which has less rigorous effectiveness requirements when the device is for a disease or condition that affects fewer than 4,000 people in the U.S. each year. According to CEO Jeffrey Allard, Fujirebio plans to collect additional data in the future to support the use of the test to detect mesothelioma.
Automated Bladder Cancer Test Cleared

Ikonisys (New Haven, Conn.) announced the FDA clearance of the oncoFISH bladder diagnostic assay. The FDA cleared the test for use on the Ikoniscope robotic digital microscopy platform. The oncoFISH assay enables automated testing of cells found in urine specimens to aid in the detection of bladder cancer.

Ortho-Clinical Diagnostics Gets Clearance for Five DOA Assays

The FDA cleared five Ortho-Clinical Diagnostics (Raritan, N.J.) MicroTip assays used to detect the presence of barbiturates, benzodiazepines, cannabinoids, methadone, and opiates in urine. The assays are for use on the company’s VITROS 5,1 system, and are processed using single-use tips and cuvettes that eliminate the risk of sample and reagent carryover.

Human Genomic Reference Controls Cleared

Gentris Corporation (Research Triangle Park, N.C.) announced the FDA clearance of its six GentriSure human genomic reference controls, the first such FDA-cleared products for genetic testing, as well as the first FDA clearance for the 6-year-old pharmacogenomics firm. The reference controls are cleared to perform diagnostic testing for the cytochrome P450 2D6 gene. Approximately 7% of the U.S. population carries a variation in the CYP2D6 gene that can cause adverse drug reactions. Gentris tested the controls using the Roche (Basel, Switzerland) AmpliChip CYP450 test. Previously, the only other sources of reference materials for CYP2D6 testing came from surplus human specimens and synthetics.

FDA Clears DCP Test for HCC Risk Assessment

Wako USA (Richmond, Va.) announced the FDA clearance of its des-gamma carboxyprothrobin (DCP) test, a test that physicians can use to assess a patient’s risk for developing liver cancer. Physicians can test for DCP, which is expressed in liver tumors, in conjunction with AFP and AFP-L3% to find liver cancer earlier in high-risk patient populations. Wako designed the DCP assay for use on its LiBASys instrument.

Drug Test Gets CLIA Waiver

The FDA granted a CLIA Waiver to the FasTox 12 drug test, marketed by Advanced Toxicology Network (Memphis, Tenn.). Designed for hospital use, the test detects 12 classes of drugs with a 10-second dip into urine and a 5-minute read time.

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