New Food and Drug Administration (FDA) draft guidance makes recommendations to manufacturers about moving SARS-CoV-2 tests and other medical devices from emergency use authorization (EUA) to full marketing and regulatory approval once the COVID-19 public health emergency ends and normal operations resume.
Once FDA sets an EUA expiration date, developers cannot distribute their tests without full approval, the draft guidance notes. Manufacturers seeking full approval should include in their submissions a “transition implementation plan” that covers both approval and denial. That plan should include the estimated number of tests currently distributed in the U.S. and address how the manufacturer will dispose of already distributed products if FDA denies the marketing submission. The plan should also explain how the manufacturer will deal with previously distributed products if FDA approves the marketing submission. The draft guidance calls upon manufacturers to explain rationale for leaving already distributed products in place and to detail a process for notifying patients, consumers, providers, healthcare facilities, and distributors about the device’s regulatory status.
If the manufacturer has submitted its test for marketing approval and FDA accepts it before the EUA termination date, the manufacturer can continue distributing the test until the agency makes a final decision, provided the label is updated. Tests from manufacturers that did not seek their full approval may be used for 2 years after the EUA termination date, or until they expire.
FDA is seeking feedback on the draft guidance through March 23, 2022. Comments can be submitted at www.regulations.gov.
FDA Says Omicron Reduces Certain Tests’ Sensitivity
The Food and Drug Administration (FDA) has found that mutations in the omicron variant lead to reduced sensitivity in certain SARS-CoV-2 PCR tests with genetic targets that cover the portion of the gene where the omicron mutations occur.
The agency recommends against using two such tests until their manufacturers resolve issues with significantly reduced sensitivity that are caused by the omicron variant. The first of these tests is Revogene SARS-CoV-2, marketed by Meridian Bioscience. The second is the Linea COVID-19 assay kit, marketed by Applied DNA Biosciences. FDA is working with these manufacturers to address the issues with their tests.
Meanwhile, the DTPM COVID-19 RT-PCR test marketed by Tide Laboratories has been modified so that it can detect the omicron variant, FDA notes.
At www.fda.gov, the agency also lists 28 tests, all with multiple genetic targets, that it considers sensitive enough to detect the omicron variant.
Roche Gets CE Mark for Saliva SARS-CoV-2 Test, Launches Other Infectious Disease Tests
Roche has announced that its cobas SARS-CoV-2 Qualitative test has received the CE mark for use on saliva samples on the widely available, high-throughput cobas 6800/8800 systems. This noninvasive test is for all individuals suspected of having COVID-19, including those without symptoms.
In addition, Roche has received the CE mark for the first infectious disease tests for use on its new cobas 5800 system. These tests support patient management of HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV), and include the cobas HIV-1, cobas HBV, cobas HCV, cobas HIV-1/HIV-2 Qualitative, and the cobas omni Utility Channel kit. Along with the cobas 5800 system, they are designed to provide standardized performance and efficiencies across low, medium, and high-volume molecular testing laboratories.
FDA Clears 1-Hour Sepsis Test
Immunexpress has announced that its SeptiCyte Rapid sepsis test has received 510(k) clearance from the Food and Drug Administration (FDA). The fully automated, 1-hour test quantifies the relative expression levels of genes involved in a patient’s immune response to infection. Used in conjunction with clinical assessments, vital signs, and other laboratory findings, the test helps differentiate actual sepsis from infection-negative systemic inflammation in patients suspected
of sepsis.
Using reverse transcription PCR, SeptiCyte Rapid quantifies relative expression levels of host response genes isolated from whole blood collected in the PAXgene Blood RNA Tube. The test then generates a score that falls within discrete interpretation bands based on the increasing likelihood of infection-positive systemic inflammation. SeptiCyte Rapid is designed for use on the Biocartis Idylla system.
NGS-Based Companion Diagnostic for Non-Small Cell Lung Cancer Gets FDA Approval
The Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific’s Oncomine Dx Target test for use as a companion diagnostic. The test, which simultaneously evaluates 23 genes associated with non-small cell lung cancer, identifies patients with tumors carrying epidermal growth factor receptor exon20-insertion mutations. Patients with these mutations could potentially benefit from treatment with Rybrevant (amivantamab-vmjw), a targeted therapy developed by Janssen Biotech.
According to Thermo Fisher officials, the Oncomine Dx Target test is the first and only FDA-approved next-generation sequencing companion diagnostic on formalin-fixed, paraffin-embedded tissue for determining Rybrevant eligibility in patients whose disease has progressed on or after platinum-based chemotherapy. The test is also approved and reimbursed by government and commercial insurers in more than 15 countries.
BD Expands Fully Automated High-Throughput Molecular Diagnostic Platform
BD (Becton, Dickinson and Company) has expanded its BD COR system to include a new MX instrument for high-throughput molecular testing for infectious diseases. The new MX instrument and its first test for sexually transmitted infections have both been CE marked. The instrument is the final piece of the BD COR system, which also includes an instrument that prepares diagnostic samples by automating appropriate preanalytical processing steps, as well as an instrument that leverages the BD Onclarity HPV assay with extended genotyping to screen for HPV infections.
The first test available on the MX instrument is the BD CTGCTV2 for BD COR system assay. The single test detects the three most prevalent nonviral sexually transmitted infections, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.
Applied BioCode Gets EUA for Respiratory Disease Test
Applied BioCode has received Food and Drug Administration (FDA) emergency use authorization (EUA) for its BioCode CoV-2 Flu Plus assay. The PCR-based, multiplex assay simultaneously detects and differentiates between SARS-CoV-2, influenza A with subtypes (seasonal H1, 2009 H1N1, H3, and influenza B), and respiratory syncytial virus using nasopharyngeal swab specimens. The test runs on the automated high-throughput BioCode MDx-3000 molecular system and enables labs to process up to 564 samples per day.