FDA Approvals: AmpliChip, Stratis ST, QuantiFERON-TB GOLD, and Others

Yael Waknine

January 11, 2005

Jan. 11, 2005 — The U.S. Food and Drug Administration (FDA) has approved a test to identify individual patient variations in drug metabolism; an implant system that simplifies the arthroscopic reconstruction of an anterior cruciate ligament torn during exercise; a blood test with higher specificity for tuberculosis than the tuberculin skin test; an expanded indication for a hair-removal system that reflects its long-term benefits; and a chronic dialysis catheter that does not require a delivery sheath to facilitate placement.

Genetic Test (AmpliChip) Identifies Slow and Fast Drug Metabolizers

On Dec. 23, the first microarray DNA test (AmpliChip Cytochrome P450 Genotyping Test, made by Roche Molecular Systems, Inc.) was approved by the FDA for use with a scanner (Affymetrix GeneChip Microarray Instrumentation System, made by Affymetrix, Inc.) to determine individual patient variations in the gene for the cytochrome P450 2D6 enzyme.

The enzyme plays a key role in the metabolism of commonly prescribed drugs, including antidepressants, antipsychotics, beta-blockers, and some chemotherapy drugs.

The in-vitro diagnostic test determines a patient's DNA sequence for the cytochrome P450 2D6 gene by matching blood-sample DNA with a "probe" of known DNA molecules arranged in a chip-like microarray. Variations in the cytochrome P450 gene provide the associated predictive phenotype (poor, intermediate, extensive, or ultra-rapid metabolizer).

The test is intended for use in conjunction with clinical evaluation and other diagnostic tools to assist physicians in selecting optimal drugs and dosing regimens for each patient while avoiding common drug interactions.

The genetic test was approved for use in the European Union on Sept. 1, 2004.

Implant System for Simplified Arthroscopic Reconstruction of Torn ACL (Stratis ST)

On Nov. 8, the FDA approved a system that includes reusable instruments and a fixation implant (Stratis ST ACL Reconstruction System) for reconstructing a torn anterior cruciate ligament (ACL).

The design of the system allows arthroscopic reconstruction with a reduced number of required steps in a procedure that eliminates complicated, time-consuming measurements. According to a company news release, the tissue-to-bone tunnel compression and fixation at the femur joint line provided by the system address key areas of surgical need that are unmet by current technology.

Use of the instruments and implant is expected to make the results of ACL reconstruction more reliable and reproducible, while reducing surgical time and patient trauma.

TB Blood Test (QuantiFERON-TB GOLD) More Accurate Than Tuberculin Skin Test

On Dec. 3, the FDA approved a diagnostic test (QuantiFERON-TB GOLD, made by Cellestis, Inc.) that detects the presence of Mycobacterium tuberculosis (TB) infection. The blood test uses synthetic TB peptides to detect gamma interferon, a protein produced by the immune system in response to TB infection.

The approval was based on the results of clinical studies showing the new test to have higher specificity (> 99%) than the tuberculin skin test. The nonsubjective test is intended to provide an effective and cost-effective screening method for TB by eliminating common false-positive results caused by non-TB mycobacterial infections and cross-reactivity to previous Bacillus Calmette-Guerin vaccination.

According to a company news release, the test is expected to replace the tuberculin skin test and provide an improved standard of care for TB control worldwide.

Hair Removal System (Aurora) for Long-term, Permanent Hair Reduction

On Oct. 25, the FDA approved an expanded indication for hair-removal systems (Aurora and derivative systems Galaxy and Pitanga, all made by Syneron, Inc., a subsidiary of Syneron Medical, Ltd.), allowing their use in effecting stable long-term or permanent hair reduction. According to a company news release, the expansion was based on positive long-term results that were reported from more than two years of clinical studies.

The systems use a proprietary electro-optical synergy platform that combines electrical energy (bipolar radiofrequency) with optical energy to treat unwanted hair on all parts of the body. The systems were originally approved in July 2002 for the removal of unwanted hair from skin types I to VI and for hair reduction.

Chronic Dialysis Catheter (ProGuide) Does Not Require Placement Sheath

On Dec. 6, the FDA approved a chronic dialysis catheter (ProGuide, made by Datascope Corp.) for use in the needleless connection of patients with end-stage renal disease to the dialysis machine.

The over-the-wire catheter does not require a sheath, thereby facilitating its placement and potentially lowering the risk of air embolism. According to a company news release, the high flow rates and low recirculation provided by the device offer a superior level of patient care.

Reviewed by Gary D. Vogin, MD

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