The Food and Drug Administration (FDA) has established a pathway to make it easier for certain molecular SARS-CoV-2 tests with emergency use authorizations (EUA) to gain additional authorization for use with pooled specimens from asymptomatic individuals as part of a serial testing program. To obtain authorization for this additional indication, test developers must submit a complete notification and meet required validation data as set forth in a letter that FDA issued on April 20. Once a test’s EUA is amended, the test may then be used with pooled anterior nasal specimens from individuals without known or suspected COVID-19 when such individuals are tested as part of a program that includes testing at regular intervals (e.g., at least once per week). The number of specimens that can be pooled (up to three, up to five, or up to 10) and the type of pooling that can be done with a test (media pooling or swab pooling) depends on the specific indication for which a manufacturer applies.
Once FDA confirms that the required documentation for a test has been submitted, the agency will add the test to a list on the agency’s website called, “Exhibit 1 of the Pooling and Serial Testing Amendment.” However, the agency notes that a test’s addition to Exhibit 1 does not necessarily mean that FDA has reviewed the underlying validation data or confirmed that the test is appropriately validated.
FDA AUTHORIZES HIGH-THROUGHPUT SYSTEM FOR THERMO FISHER SARS-COV-2 TEST
Thermo Fisher Scientific has received emergency use authorization (EUA) from the Food and Drug Administration for the Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo kit. The Amplitude Solution is designed to enable clinical and public health laboratories to expand polymerase chain reaction (PCR) testing and process up to 8,000 samples in a single day even with limited personnel. It combines Thermo Fisher’s extraction and real-time PCR instruments with liquid handling products from Tecan Group, and comes with a secured supply of kits, reagents, and other consumables to meet SARS-CoV-2 testing needs. The modular system also uses a high-throughput version of Thermo Fisher’s Applied Biosystems TaqPath COVID-19 Combo kit (which received an EUA in March 2020) to process samples in four steps with minimal hands-on time and laboratory space requirements. Additionally, the kit’s multigene target design and updated interpretive software could help labs detect SARS-CoV-2 variants.
CE MARK GIVEN TO ADVANCED BIOLOGICAL LABORATORIES SARS-COV-2 VARIANTS TEST
Advanced Biological Laboratories has earned the CE mark for its UltraGene SARS-CoV-2 Triplex assay. This test uses real-time reverse transcription polymerase chain reaction (PCR) to identify SARS-CoV-2 RNA, detect the presence of SARS-CoV-2 variants, and distinguish between the main circulating SARS-CoV-2 variants of lineages B.1.1.7, B.1.351, and P.1. Designed for use with upper respiratory specimens, the UltraGene SARS-CoV-2 Triplex assay is available in a two-wells-per-sample format. The first well includes primer and probe sets designed to detect RNA from the SARS-CoV-2 nucleocapsid (N) and envelope (E) genes, as well as an extraction, reverse transcription, and PCR amplification positive control. The second well includes primer and probe sets designed to detect RNA from the N gene, as well as genomic variations in the spike (S) and ORF1ab genes, enabling identification of the aforementioned SARS-CoV-2 variants. Validated on the UltraGene qPCR 48 and Applied Biosystems QuantStudio 5 instruments, the test works on platforms equipped with FAM, HEX, Cy 5, and ROX and fluorescent channels and is available in two models for two distinct workflows.
GENOMSYS EARNS CE MARK FOR GENOMIC PROCESSING DATA SOFTWARE
The CE mark has been granted to GenomSys for its MPEG-G Codec Suite, a collection of software tools designed to process genomic data so that it’s compliant with the ISO/IEC-23092 genomic data standard (MPEG-G). The MPEG-G Codec Suite includes source code examples, a comprehensive user manual, and additional software to transcode from and to legacy formats (to preserve past investments) and to integrate functionalities into existing applications and pipelines. With these tools, laboratories can transform their legacy formatted files into MPEG-G and leverage the accompanying efficiencies and high-security level that comes with this widely interoperable data standard. In addition to providing benefits related to data protection, MPEG-G can enable cost savings for organizations handling large volumes of genomic data by significantly reducing the size of whole-exome sequencing files. MPEG-G also can shorten the time needed to process genomic data by more than 89% since it does not require any preprocessing steps during analysis.
CE MARK GRANTED TO CURIOSITY DIAGNOSTICS FOR RAPID POC MRSA TEST
The ultrafast PCR|ONE system, developed by Curiosity Diagnostics (a wholly owned special purpose vehicle of Scope Fluidics), has received the CE mark for the diagnosis of methicillin-resistant Staphylococcus aureus (MRSA). Consisting of an analyzer and disposable cartridges, the PCR|ONE platform is a standalone system that detects up to 20 pathogens and genetic targets in a single run of the instrument at the point of care. It uses proprietary infrared amplification technology to perform 40 cycles of real-time polymerase chain reaction (PCR) in 7 minutes, enabling the system to identify bacteria and viruses on a molecular level in 15 minutes. It also performs each PCR in triplicate in order to maximize accuracy. For the drug-sensitive form of Staphylococcus aureus, the system demonstrates 96.8% sensitivity and 97.1% specificity, while for MRSA, the system demonstrates 95% sensitivity and 100% specificity.
BINX HEALTH GETS CLIA WAIVER FOR POC CHLAMYDIA/GONORRHEA TEST
The Food and Drug Administration (FDA) has granted a CLIA waiver to Binx Health for the IO CT/NG assay, which detects Chlamydia trachomatis and Neisseria gonorrhoeae in female vaginal swabs and male urine specimens. Using a single-use, assay-specific cartridge, the binx IO platform combines ultra-rapid polymerase chain reaction amplification with Binx Health’s proprietary electrochemical detection technology to produce results in approximately 30 minutes. Studies have evaluated the IO CT/NG assay in females 16 years and older and in males 17 years and older and have demonstrated that its performance is comparable to tests performed in a CLIA certified laboratory that meets the requirements for high or moderate complexity testing. With this CLIA waiver, the IO CT/NG assay can now be performed in point-of-care settings such as physician offices, community-based clinics, urgent care settings, and outpatient healthcare facilities.