The Food and Drug Administration (FDA) has issued a safety communication warning patients and healthcare professionals not to use test strips for glucose or warfarin international normalized ratio (INR) that are either from a previous owner or that FDA has not authorized for sale in the U.S. These test strips could lead to infection or inaccurate test results, causing serious harm or even death. FDA issued this warning because sellers are marketing pre-owned or unauthorized glucose and INR test strips either directly to consumers or through online marketplaces such as Amazon, eBay, and Craigslist. While the agency is not aware of any deaths or serious injuries specifically associated with these pre-owned or unauthorized test strips, these strips still might not be safe to use because they could be expired or stored improperly, which can lead to inaccurate results. It’s also possible that the test strips could have small amounts of blood from the previous owner on them, which can put users at risk of infection.
To determine whether or not a test strip is pre-owned or unauthorized, FDA recommends inspecting the package to check whether it has been opened or altered and to check expiration dates. An additional sign that prescription-only test strips may be unauthorized for sale in the U.S. is if they can be purchased without a prescription. Overall, FDA advises patients and healthcare providers to only purchase test strips from a trusted source, such as a local pharmacy or through the test strip manufacturer.
Following FDA Warning Letter, Inova Genomics Pulls Plug on Pharmacogenetic Tests
Inova Genomics Laboratory has stopped offering its MediMap pharmacogenetic tests in response to a warning letter from the Food and Drug Administration (FDA). The letter asserted that, because these tests had not been reviewed by FDA for safety and effectiveness, Inova was illegally marketing them. The MediMap tests claimed to use genetic variants to predict patients’ responses to specific medications, including antidepressants, opioids, cancer treatments, anesthesia, and diabetes medications. However, FDA stated that it was unaware of any data establishing that Inova’s tests were able to help patients or healthcare providers make appropriate treatment decisions for the listed drugs, and that the agency was concerned these tests could lead to serious health consequences for patients.
FDA requested that Inova respond to the warning letter within 15 working days of its receipt with details of how the company would address this issue. In response, Inova released a statement saying, “After thoroughly reviewing the letter, which clarified FDA’s approach to laboratory-developed tests for pharmacogenomics, Inova has decided to end MediMap tests.”
FDA Clears Beckman Sepsis Test, Flow Cytometry System for Leukemia, Lymphoma
Beckman Coulter has received Food and Drug Administration (FDA) clearance for both the Early Sepsis Indicator and the ClearLLab 10C system for clinical flow cytometry labs. The Early Sepsis Indicator tests for a hematology-based cellular biomarker, known as monocyte distribution width and is designed to help emergency department clinicians identify patients with sepsis or increased risk of developing sepsis. Results for the test are automatically reported as part of a routine complete blood count with differential for adult emergency department patients. Compared with reviewing white blood cell count alone, clinical trials show that the Early Sepsis Indicator strengthens clinician confidence in ruling in sepsis by 43% and, together with clinical signs and symptoms, improves clinician confidence in ruling out sepsis by 63%.
The ClearLLab 10C system comprises four 10-color in vitro diagnostic panels of immunophenotyping reagents cleared by FDA for both lymphoid and myeloid lineages. The panels’ four dry, premixed antibody tubes use the company’s Dry Unitized Reagent Assays Innovations technology, which eliminates the need to pipette antibodies. Alongside the panels, the ClearLLab 10C system includes ClearLLab control cells, a liquid preparation of stabilized human erythrocytes and leukocytes that serve as controls for leukemia and lymphoma immunophenotyping; and new ClearLLab compensation beads for use with the ClearLLab compensation kit.
InDevR Gets FDA OK for Test That Differentiates Seasonal, NonSeasonal Flu Viruses
The Food and Drug Administration has granted 510(k) clearance to InDevR for its FluChip-8G Influenza A+B assay. FluChip-8G is a single multiplexed assay that provides same-day results and is the first FDA-cleared influenza diagnostic that qualitatively detects and differentiates between seasonal and nonseasonal influenza A viruses, while also identifying the genetic lineage of influenza B viruses. The influenza A viruses characterized by the test include subtypes with recognized pandemic potential such as H7N9 and H5N1. Overall, this means that the test could be used as part of an early warning system for the emergence of new strains of influenza. The FluChip-8G is an open platform molecular diagnostic system consisting of a low-density microarray and reagent kit, microarray imaging system, and custom software. The assay uses multiplexed reverse transcriptase polymerase chain reaction to amplify whole influenza gene segments, followed by detection on a microarray. The test also uses artificial intelligence-based pattern-recognition to automate result interpretation.
NY State Authorizes Veracyte Genomic Test for Idiopathic Pulmonary Fibrosis
Veracyte has received regulatory authorization from the New York State Department of Health to offer the Envisia genomic classifier to patients in the state. This genomic test is the first commercially available diagnostic that helps distinguish idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases (ILD). It was developed using RNA whole-transcriptome sequencing and machine learning to identify the usual interstitial pneumonia pattern that is a hallmark of IPF. The test assesses patient samples obtained through bronchoscopy, a nonsurgical procedure commonly used in lung evaluation, and is used as a complement to high-resolution computed tomography (HRCT), the method typically used along with a clinical work-up to help identify IPF. Studies show a high correlation between results obtained with the Envisia classifier and histopathology results read by ILD experts, the latter being the gold standard method for confirming HRCT results. This means that Veracyte’s test will enable patients to forgo surgical lung biopsy even if their HRCT results are indeterminate.