News From the FDA

FDA Proposes Amending Overseas Requirements for Medical Device Submissions

FDA has proposed updating the regulations on acceptance of data from clinical studies for medical devices. The goal of the update would be to protect the human subjects involved in these studies, as well as to ensure high-quality data and results. Currently, the changes would affect medical device submissions involving clinical studies conducted outside the U.S., though FDA is considering amending the investigational device exemption (IDE) and 510(k) regulations for clinical studies conducted in the U.S.

The suggested changes would require that international clinical studies conducted as support for an IDE application, a 510(k) submission, a premarket approval application, a product development protocol application, or a humanitarian device exemption application comply with good clinical practice (GCP). Following GCP involves obtaining and documenting the review and approval of the study by an independent ethics committee, and obtaining and documenting freely given informed consent of study subjects. FDA hopes that these proposed updates will help standardize FDA requirements for acceptance of clinical data for all application and submission types.

The agency is accepting comments on the proposal until May 28.

Roche Receives FDA Approval for HCV Test

FDA approved Roche's COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0. The new assay is intended as an aid in the management of patients with chronic hepatitis C virus (HCV) infection. This addition to Roche's HCV diagnostics portfolio uses real-time polymerase chain reaction to quantify HCV RNA genotypes 1 to 6 in human EDTA plasma or serum. It works on Roche's fully automated, viral load monitoring platform, the COBAS AmpliPrep/COBAS TaqMan system, and includes a dual-probe approach that offers extra protection to users when detecting and quantifying the virus. Clinicians can use the test's results to assess patients' response to antiviral therapy and to predict the probability of a sustained virologic response.

ASI Receives FDA Nod for ALK Gene Analysis Aid

Applied Spectral Imaging (ASI) received FDA clearance for its GenASIs Scan & Analysis automated microscopy platform that functions as an aid in ALK gene analysis for lung cancer therapy selection.

GenASIs is cleared for Abbott's Vysis ALK Break Apart FISH Probe test, which identifies ALK-positive non-small cell lung cancer (NSCLC) patients for Pfizer’s NSCLC oral ALK inhibitor, Xalkori (crizotinib). Using an 81-slide continuous scanning robot, GenASIs enables clinicians to perform automated genetic analysis on tissue samples stained with Abbott’s ALK probe kit to detect the ALK gene rearrangement. Additional FISH clinical applications for which GenASIs is FDA cleared include UroVysion, HER2/neu, CEP XY, and karyotyping.

FDA Clears U.S. Arkray Urine Analyzer

FDA cleared U.S. Arkray's Fully Automated Integrated Urine Analyzer Aution Hybrid AU-4050. The Aution Hybrid AU-4050 combines Arkray's urinalysis strip technology with fluorescent flow cytometry sediment analysis in a compact unit designed to fit laboratories of all sizes. This latest addition to Arkray's urinalysis portfolio also offers continuous sample loading averaging a rate of 150 samples per hour, and full reflex testing capabilities that allow labs to perform urine analysis on the same platform with minimal interaction.

FDA Approves Dako Breast Cancer CDx

Dako received FDA approval for HER2 IQFISH pharmDx, a fluorescence in situ hybridization (FISH) assay, for the assessment of breast cancer patients being considered for therapy that specifically targets HER2, such as trastuzumab. This is the first product approved by FDA based on Dako's instant quality in situ hybridization (IQISH) technology. Using this technology, the HER2 IQFISH pharmDx assay reduces the time needed to identify HER2 gene status in breast cancer patients from 2 days to 3.5 hours. IQFISH also replaces a hazardous formamide buffer traditionally used in FISH analysis with a nontoxic ethylene carbonate.

FDA also granted Dako approval for the addition of Kadcyla in the labeling of HER2 IQFISH pharmDx and HercepTest, the company's other co-diagnostic for HER-specific treatment. Kadcyla is Genentech's new therapeutic for patients with HER2-positive metastatic breast cancer who have received prior treatment with Genentech's medicine Herceptin (trastuzumab) and a taxane chemotherapy. Both HER2 IQFISH pharmDx and HercepTest were developed as part of a collaboration with Genentech initiated in early 2012.