The Food and Drug Administration has granted de novo marketing authorization to Roche for the cobas vivoDx MRSA diagnostic test, which detects methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization. This test identifies patients who require enhanced precautions for infection control such as isolation and additional decolonization efforts. It detects MRSA from nasal swab samples in as little as 5 hours using Roche’s Smarticles technology, which uses bioparticles to deliver DNA encoded with a bioluminescent reporter gene into MRSA bacteria. These bioparticles have a shell derived from MRSA-specific bacteriophages that binds to receptors on the surface of target bacteria. Once the bioparticles bind to and inject DNA into their targets, live MRSA bacteria then go on to produce light when the proper substrate is added. This enables detection of viable bacteria directly from clinical samples.
In performance studies, this method correctly identified MRSA in approximately 90% of samples in which MRSA was present and correctly identified no MRSA in 98.6% of samples that did not have MRSA present.
PerkinElmer Gets FDA Nod for Duchenne Muscular Dystrophy Newborn Screening Test
PerkinElmer has received de novo marketing authorization from the Food and Drug Administration (FDA) for the GSP Neonatal Creatine Kinase-MM (CK-MM) kit. This is the first test to earn FDA authorization that aids in newborn screening for the genetic disorder Duchenne muscular dystrophy (DMD). The kit measures concentrations of the protein CK-MM from dried blood samples collected via heel-stick from newborns 24 to 48 hours after birth. If a patient’s CK-MM levels were found to be elevated, this could indicate the presence of DMD, and labs would then confirm this finding with further testing such as muscle biopsies, genetic, and other laboratory tests. To evaluate the GSP Neonatal Creatine Kinase-MM kit, FDA reviewed data from a clinical study of 3,041 newborns whose dried blood samples were tested for protein levels that are associated with DMD. In the study, the kit accurately identified the four screened newborns who had DMD-causing genetic mutations.
FDA Approves Myriad’s BRACAnalysis Test as a Co-Diagnostic for Pancreatic Cancer
The Food and Drug Administration (FDA) has approved Myriad Genetics’ BRACAnalysis CDx for use as a companion diagnostic to identify patients with metastatic pancreatic cancer who have a germline BRCA mutation and are candidates for treatment with Lynparza (olaparib). BRACAnalysis CDx detects and classifies oncogenic variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes, while Lynparza is a poly (ADP-ribose) polymerase inhibitor marketed by AstraZeneca and Merck. Previously, FDA approved BRACAnalysis CDx to identify candidates for Lynparza treatment who have either advanced ovarian cancer; recurrent platinum-sensitive germline BRCAm ovarian cancer; or germline BRCAm metastatic breast cancer that has been treated with chemotherapy. As part of Myriad’s ongoing collaboration with AstraZeneca, the company also recently submitted a new supplementary premarket approval application to FDA for BRACAnalysis CDx as a companion diagnostic to Lynparza for men with metastatic castration-resistant prostate cancer.
CareDx Receives CE Mark for cfDNA Organ Transplant Monitoring Test
CE mark approval has been given to CareDx for its AlloSeq cfDNA kit, which aids with organ transplant surveillance by quantifying donor-derived cell-free DNA (dd-cfDNA) in transplant recipients. When graft injury occurs, dd-cfDNA increases in the blood, and studies have shown that this is a more accurate indicator of active transplant rejection than serum creatinine. The AlloSeq cfDNA works by first preparing a sequencing library. For each sample, the test performs a single multiplex polymerase chain reaction (PCR) that involves simultaneous locus-specific amplification of the targeted genes of interest and index PCR. Next, samples are pooled, purified, and quantified for sequencing on an Illumina MiSeq instrument. The AlloSeq cfDNA software then analyzes the results, using the fraction of donor-specific nucleotides at single nucleotide polymorphism loci to determine the patient’s levels of dd-cfDNA. Altogether, this process takes 24 hours. Separate genotyping of the donor or recipient is typically not required but may be advised depending on the use case.
CE Mark Granted to Baebies for Pediatric Enzyme Deficiency POC Test
Baebies has earned the CE mark for Finder, a point-of-care testing platform that tests for glucose-6-phosphate dehydrogenase (G6PD) deficiency, which causes a spectrum of diseases including neonatal hyperbilirubinemia, acute hemolysis, and chronic hemolysis. Finder is designed for use in a variety of settings, from neonatal intensive care units to birthing centers. The platform uses digital microfluidic technology, which enables testing using a low volume (50 μL) of whole blood, and it has a turnaround time of approximately 15 minutes. It also involves only one step for the user—loading the sample—and features a cartridge with all necessary reagents onboard, including those for sample preparation, as well as a tablet for user interface. In the U.S., Finder is currently undergoing a clinical trial, which Baebies plans to complete in early 2020 for Food and Drug Administration 510(k) submission.
FDA Clears Applied BioCode’s Syndromic Respiratory Pathogen Panel
The Food and Drug Administration has given 510(k) clearance to Applied BioCode for its BioCode Respiratory Pathogen Panel (RPP) for use on the BioCode MDx-3000 system. The BioCode RPP tests nasopharyngeal swabs for the most common viruses and bacteria, including influenza A and subtypes H1, H1N1 2009pdm and H3; influenza B; respiratory syncytial virus A/B; parainfluenza virus types 1, 2, 3, and 4; human metapneumovirus A/B; adenovirus; rhinovirus/enterovirus; coronavirus (229E, OC43, HKU1, and NL63); Mycoplasma pneumoniae; Chlamydia pneumoniae; and Bordetella pertussis. The BioCode MDx-3000 system on which the test runs combines the amplification, hybridization and target capture, and detection steps for the RPP assay, and processes up to 188 samples in an 8-hour shift. The system is based on Applied BioCode’s Barcoded Magnetic Beads technology, which uses biocompatible polymeric magnetic beads to digitally barcode biomarkers. The BioCode MDx-3000 also offers flexible ordering and reporting capabilities to accommodate variations in test ordering patterns and potential changes in reimbursement.