CLN Article

News From the FDA

In This Issue...

FDA Releases Final Guidance on Research Use Only/Investigational Use Only Products

The Food and Drug Administration (FDA) has issued a final guidance on properly labeling in vitro diagnostic (IVD) products "for research use only" (RUO) or "for investigational use only" (IUO). FDA is concerned about the distribution of unapproved or uncleared IVD products labeled RUO or IUO for purposes other than research or investigation. Many labs use RUO products for lab-developed tests. While not barring labs from using RUO and IUO products, the agency emphasized in the final guidance that it believes that in some instances, clinical use of RUO and IUO products has led healthcare providers to use products with unproven performance characteristics and inadequate manufacturing controls. Patients could suffer serious negative health consequences if they are diagnosed with or treated based on the results of such tests, FDA warned. To reduce risk, FDA is clarifying the requirements for RUO and IUO diagnostic products, including how RUO and IUO labeling must reflect the manufacturer's intended use of the device.

More information about this guidance is available at

FDA Clears Additional Specimen Types for Roche Chlamydia, Gonorrhea Test

FDA gave Roche 510(k) clearance for the use of four additional specimen types with the cobas CT/NG v2.0 Test, a real-time PCR-based assay for the diagnosis of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in symptomatic and asymptomatic patients. In addition to self-collected vaginal swabs (collected in a clinical setting) and male urine specimens, the test can now be performed with endocervical and clinician-collected vaginal specimens, female urine specimens collected in cobas PCR media, and cervical specimens collected in PreservCyt solution. The test is designed to run on the cobas 4800 system, the only FDA-approved platform to offer primary vial loading for both CT/NG and HPV testing. The clearance of these new specimen types will allow labs using the cobas 4800 system to combine CT/NG and HPV testing onto a single automated platform.

FDA Grants BD Clearance for Assay That Detects Staph, New MRSA Strains

BD Diagnostics received FDA clearance for the BD Max StaphSR Assay that runs on the fully-automated BD Max system. Using Extended Detection Technology, this test directly identifies Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs, including mecA dropout mutants and new strains of MRSA that other assays may not detect. It is also the first commercially-available molecular assay in the U.S. that detects recently discovered MRSA strains with the mecC gene. According to BD, the assay produces results within approximately 2 hours compared to the 2 or more days needed for culture methods.

Illumina Receives FDA Clearance for Next-Generation Sequencing Device, Assays

Illumina's MiSeqDx system has become the first high-throughput DNA sequencing analyzer to receive FDA clearance. This bench top sequencer uses the company's sequencing by synthesis chemistry, and allows users to run diagnostic or research applications on a single system. The first tests cleared for this platform include Illumina's MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal kit.

The MiSeqDx Cystic Fibrosis 139-Variant Assay simultaneously detects 139 clinically relevant disease-causing mutations and variants within the cystic fibrosis transmembrane conductance regulator (CFTR) gene. These include all cystic fibrosis-causing variants recommended for carrier screening purposes by the American College of Medical Genetics and Genomics and the American College of Obstetricians and Gynecologists. The MiSeqDx Cystic Fibrosis Clinical Sequencing Assay also analyzes the CFTR gene, and provides sequencing data for the gene's protein coding regions and intron/exon boundaries.

As for the MiSeqDx Universal kit, it allows laboratories to develop and validate sequencing of any part of a patient's genome. The kit includes library preparation reagents, sample index primers, and sequencing consumables needed for developing amplicon assays on the MiSeqDx platform.

FDA Clears PrimeraDx PCR System and C. difficile Assay

PrimeraDx received FDA clearance for the IcePlex system, a quantitative multiplex PCR system that combines PCR technology with capillary electrophoresis. Integrating both of these technologies into a single bench top instrument enables the amplification and quantification of multiple nucleic acid species of different types in a single reaction, starting from fresh, frozen, or formalin-fixed paraffin-embedded samples. This makes the IcePlex system suitable for high-multiplex assays that test for disparate target types such as SNPs, expression biomarkers, microRNAs, and fusion genes.

The first test cleared on this platform is the IcePlex C. difficile Assay kit, a molecular diagnostic test for the detection of Clostridium difficile in human stool samples.

RPS Gets FDA Nod for Dry Eye Disease Test

FDA has granted clearance to Rapid Pathogen Screening for InflammaDry, the company's dry eye disease test. InflammaDry is the first and only disposable, single-use, point-of-care test to detect matrix metalloproteinase 9, a biomarker that is consistently elevated in the tears of patients with dry eye disease. Using a small sample of human tears, the four-step test takes less than 2 minutes to administer, and within 10 minutes, it displays a blue control line for a negative result or blue and red lines for a positive result. No additional equipment is required to perform InflammaDry or interpret its results. This clearance allows physicians' offices to use the InflammaDry test if they are certified under CLIA to perform moderately complex tests.