Canary Global has received the CE mark for its DigiGENE COVID-19 Rapid Molecular test kit, a self-collected, multi use, rapid point-of-care molecular test that uses saliva to detect SARS-CoV-2.

The test is now cleared for sale and distribution in the European Union. It processes four samples simultaneously, yields a positive result in 5 minutes, and a negative result in less than 20 minutes. DigiGENE says the test is suitable for settings where quick, accurate results are needed for large numbers of people. These settings include schools, airports, event venues, international border crossings, and businesses.

The kit consists of a handheld, reusable digital reader and disposable testing cartridges that feature digital detection technology capable of analyzing multiple targets to detect SARS-CoV-2. This lab-on-a-chip technology combines loop-mediated isothermal amplification, smart sensors, and cloud-based analytics.

With a limit of detection of 600 copies of RNA per mL, this molecular test is on par with most lab-based PCR tests, according to the company. It requires neither special lab equipment nor professional operators. Users get an immediate, verified test result sent to their mobile devices. HIPAA-compliant results from the test can also be sent to public health authorities for contact tracing and surveillance purposes.

DigiGENE says it is now preparing to submit the test kit for Food and Drug Administration review, with an eye toward emergency use authorization for use at home and at the point of care.

Mammoth Biosciences Gets FDA EUA for First CRISPR-based High-Throughput SARS-CoV-2 Test

The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Mammoth Biosciences’ Detectr Boost SARS-CoV-2 Reagent kit, a high-throughput solution that combines the sensitivity of CRISPR with laboratory automation for SARS-CoV-2 testing.

According to the company, the Detectr Boost platform is a turnkey, CRISPR-based molecular diagnostic system that enables high-throughput, sample-to-answer testing with PCR-equivalent performance and minimal hands-on time. Together with the Agilent Bravo BenchCel DB liquid handling platform, the Detectr Boost SARS-CoV-2 Reagent kit detects SARS-CoV-2 RNA in nasopharyngeal, anterior nasal, mid-turbinate nasal, or oropharyngeal swab specimens from individuals with COVID-19.

FDA Clears Sepsis Quality Control Product

Streck recently announced that the Food and Drug Administration (FDA) has cleared its MDx-Chex for BCID2, which provides quality control designed to meet standards for verifying performance of the BioFire BCID2 panel for sepsis.

 MDx-Chex for BCID2 is a patient-like, full process control designed to validate each sample processing step included in the pouch for BioFire’s BCID2 panel. The control kit contains 43 bacteria, yeast, and antimicrobial resistance gene targets. They are packaged in two separate vials, one for gram-negative bacteria and one for the gram-positive bacteria and yeasts detected by the BioFire BCID2 assay. The microorganisms are intact, inactivated, and suspended in a matrix of stabilized red blood cells, white blood cells, and blood culture media components, which are designed to challenge the lysis and purification processes like a patient sample.

Company officials say the cleared control will enable labs to perform all crucial sample processing steps needed for nucleic acid amplification tests and instrumentation.

FDA Clears Molecular test and Workstation for Sexually Transmitted Infections

The Food and Drug Administration (FDA) recently granted 510(k) clearance to the Rheonix automated Encompass MDx workstation, along with the company’s STI TriPlex assay and Male Urine Collection Kit for the detection of sexually transmitted infections (STIs).

The fully automated Encompass MDx workstation enables
multiplexed sample-to-answer detection, and is designed to simplify laboratory workflows and reduce the burden on laboratory technicians.

The Rheonix STI TriPlex assay is approved for simultaneous detection and differentiation of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Rheonix will also seek FDA approval for additional syndromic diagnostic panels that leverage the Encompass MDx workstation’s ability to perform simultaneous detection of multiple target organisms from a single clinical sample.

Other assays in the Rheonix pipeline include a multiplexed
test for simultaneous detection of respiratory pathogens including SARS-CoV-2, influenza, and
respiratory syncytial virus; a panel of leading organisms that cause gastrointestinal infection; and STI assays with expanded targets and sample types.

Microbiome Test CE-Marked and Launched on New Platform

The microbiome diagnostics company Genetic Analysis (GA) recently announced that it has received the CE mark for its GA-map Dysbiosis test on Magpix, a new platform from the company Luminex.

The Magpix instrument is the most affordable among Luminex’s xMAP instruments and enables up to 50 plex using MagPlex Microspheres. It has already become a widely used platform for performing other tests.

The availability of GA-map on the Magpix instrument system complements GA’s new availability on the Luminex LX200 instrument. It provides a less costly option to customers who plan to install a Luminex system for GA-map testing only, and it also enables Magpix customers to add microbiome testing to their current test portfolios.

Seegene’s Allplex Respiratory Panel Receives Canadian Interim Approval

Seegene, a South Korean molecular diagnostic company, has earned approval of its Allplex SARS-CoV-2 FluA/FluB/RSV assay under Health Canada’s Interim Order. The test is a multiplex real-time PCR assay that can both amplify and distinguish among influenza A, influenza B, respiratory syncytial virus, and SARS-CoV-2. Noting the demand for SARS-CoV-2 tests, Seegene officials say the company is prepared to provide its Allplex test globally. The company also hopes that the assay will aid in the response to a surge in both flu patients and COVID-19 patients.

Newly CE-Marked Test Detects SARS-CoV-2 Variants

PathogenDx recently announced that its real-time SARS-CoV-2 PCR test Detectx-Cv+ has received the CE mark. The PathogenDx Detectx-Cv+ test is a molecular biology real-time PCR test coupled with DNA microarrays designed to detect the SARS-CoV-2 virus plus emerging variants of concern and
of interest.

Company officials noted that as of 2021, the virus had mutated more than 30 times. Without genomic surveillance involving quick turnaround, data on new variants becomes too old to have public health value. The officials said that Detectx-Cv+ can identify both SARS-CoV-2 and its variants with a turnaround time of less than 6 hours, enabling same-day results. No high-end bioinformatics are required, officials added.