Labcorp has announced Food and Drug Administration emergency use authorization for a home collection kit that detects SARS-CoV-2 and influenza A/B simultaneously in individuals as young as 2 years old.
Called Pixel by Labcorp, the kit became available in October 2021. Samples collected with the kit are analyzed using the Roche cobas SARS-CoV-2 & influenza A/B test, which runs on the high-volume cobas 6800/8800 systems. This PCR test simultaneously identifies and differentiates SARS-CoV-2, influenza A, and influenza B—a multiplex approach that will help to increase lab efficiency and save resources, according to Labcorp. The test also has full-process negative, positive, and internal controls.
Pixel is available at no upfront cost to those who meet clinical guideline criteria, which may include experiencing symptoms of COVID-19, being exposed to someone with COVID-19, or being asked to get tested by a healthcare provider.
Adult patients can order the combined collection kit online through the Pixel by Labcorp website. Physicians also can order the kits directly from their electronic medical record systems.
Labcorp ships the home collection kit to consumers via FedEx Priority Overnight along with a prepaid return envelope. Then, once an individual returns the completed collection kit to Labcorp, test results are available on average between 1-2 days after receipt.
LBT’s MRSA Analysis Module Gets FDA Clearance
The Australian medical technology company LBT Innovations recently announced that it has received Food and Drug Administration (FDA) 510(k) clearance for its APAS Independence with associated analysis methicillin-resistant Staphylococcus aureus (MRSA) module, a culture plate reading technology.
LBT’s MRSA analysis module automatically reads and reports the negative MRSA plates that typically account for over 95% of total MRSA workflow. This enables users to process more tests through the APAS instrument, delivering increased efficiency and cost savings for labs, according to company officials.
A study by Johns Hopkins Hospital found the APAS Independence successfully identified all positive MRSA specimens, including five positive samples previously missed by microbiologists.
Along with the June 2019 FDA clearance for the APAS Independence with urine analysis module, there are now two analysis modules cleared for use on the APAS Independence in the United States. Each analysis module is sold to customers as a separate software license and available to customers as a software upgrade.
Hologic’s Multiplex COVID-19/Flu Commercially Available in North America and Europe
Hologic’s Aptima SARS-CoV-2/Flu assay has received Food and Drug Administration emergency use authorization and is now available in the United States for the simultaneous detection and differentiation of three respiratory viruses that present with overlapping clinical symptoms. The three viruses—SARS-CoV-2, influenza A, and influenza B—typically cause fever, cough, headache, and fatigue.
The Aptima SARS-CoV-2/Flu assay uses both anterior nasal swab and nasopharyngeal samples. The test can also be used with samples from multiple collection devices, including Hologic’s Direct Load collection kits, which are designed to reduce risk of viral transmission and improve laboratory efficiency. The assay runs on Hologic’s fully automated Panther system, which provides initial results in approximately 3 hours and can process more than 1,000 tests in 24 hours.
Hologic said its assay will provide greater flexibility and testing options for labs and healthcare providers during the U.S. flu season.
PerkinElmer Respiratory Panel Receives FDA EUA
A Food and Drug Administration emergency use authorization for PerkinElmer’s PKamp Respiratory SARS-CoV-2 real-time PCR Panel 1 assay means that labs can now use it for simultaneous qualitative detection and differentiation of common respiratory viruses. Those viruses include SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus. The assay uses samples from nasopharyngeal swabs, anterior swabs, and mid-turbinate swabs.
PerkinElmer officials noted that the Centers for Disease Control and Prevention has encouraged labs to adopt a multiplex method that detects and differentiates these viruses, which cause similar symptoms. The new test will allow labs and the wider healthcare system to conserve resources by avoiding multiple tests on samples from individuals suspected to have COVID-19.
GenomSys Variant Analyzer Gets CE Mark
GenomSys, a pioneer in the development and adoption of the ISO/IEC 23092 MPEG-G open standard for genomic data, has obtained a CE mark for and launched its latest GenomSys Variant Analyzer. The tool enables genomic professionals to leverage the benefits of the new genomic standard MPEG-G and the most updated databases on human genetic variants. GenomSys officials noted that the National Institutes of Health predicts widespread genome sequencing by 2030, adding that their tool will help handle vast amounts of genomic data more reliably and efficiently.
The GenomSys Variant Analyzer takes full advantage of MPEG-G and user-friendly dashboard and cloud-based architecture, and is designed to allow geneticists to focus more on analysis than bioinformatics. Company officials added that the platform features an extensive range of dynamic filtering options to adapt and tailor analytical criteria, integration of Varsome-curated databases, faster data access time and storage reduction, and automated workflow for secondary and tertiary analysis.
Genetron Health’s Multi-Gene Cancer Mutation Detection Kit Obtains CE Mark
Genetron recently announced that its proprietary large-panel product, Onco PanScan (Mutation Detection Kit for Human Multi-Genes), has obtained the CE mark.
Genetron, a Chinese company, said that Onco PanScan is a comprehensive genomic profiling test based on hybridization capture and next-generation sequencing technology. By combining coverage of different gene mutation regions and genetic variants observed in thousands of cases with different tumor types, the detection kit covers more than 800 genes recommended by international treatment guidelines. Those guidelines were issued by groups including the World Health Organization, National Comprehensive Cancer Network, and the European Society for Medical Oncology.
Onco PanScan is suitable for targeted therapy, immunotherapy treatment guidance, and screening for susceptibility to genetic risks, the company added.
Genematrix HPV29 Kit Gets CE-IVD Certification
Genematrix, a South Korean specialist in real-time PCR diagnostics, recently announced that its NeoPlex HPV29 Detection test has received the CE mark in Europe. The test identifies 29 genotypes of human papillomavirus (HPV), which causes cervical cancer. Genematrix officials said that the product can also reduce turnaround time by more than an hour, compared to existing products on the market.