The Food and Drug Administration (FDA) has given emergency use authorization (EUA) to Labcorp’s Seasonal Respiratory Virus RT-PCR DTC test. This direct-to-consumer test detects and differentiates RNA from SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) in patients with respiratory viral infection symptoms aligning with COVID-19. Consumers may use the Pixel by Labcorp COVID-19+Flu+RSV test home collection kit to collect anterior nasal swab specimens. Users should then follow Pixel’s instructions to mail specimens to authorized laboratories for analysis with the Seasonal Respiratory Virus test. This testing is limited to Labcorp-designated laboratories that are certified
under CLIA to perform high complexity tests.

Under the terms of FDA’s EUA for the product, people age 18 years or older can use the test themselves, people age 14 years or older can test themselves under adult supervision, and people age 2 years or older can test with adult assistance. Patients receive their test results through an online portal. If a patient receives positive results, a healthcare provider will contact the person and determine if self-isolation or quarantine is appropriate.

FDA Clears Abbott’s Freestyle Libre 3

Abbott has received Food and Drug Administration clearance for the Freestyle Libre 3, a 14-day continuous glucose monitor (CGM) that is the smallest in the world, according to the company. With this clearance, people 4 years and older who have diabetes may use this CGM system. It has a 7.9% overall mean absolute relative difference (MARD), making it the first CGM to feature a MARD under 8%. Alongside its high accuracy, the system is the size of two stacked U.S. pennies and comes with a one-piece applicator that makes it easy to apply. The Freestyle Libre 3 also includes an iOS and Android app that provides real-time glucose tracking and alerts users to the onset of serious medical events.

Freestyle Libre 3 will be available at pharmacies later this year and will be sold for the same price as previous Freestyle Libre models.

FDA Approves Hologic’s Aptima CMV Quant Assay

The Food and Drug Administration (FDA) has approved Hologic’s Aptima CMV Quant assay, which quantifies cytomegalovirus (CMV) in patients who have had solid organ or stem cell transplants. Performed on plasma samples, it uses real-time transcription-mediated amplification and targets the UL56 gene, with a time-to-result of < 3 hours. It is the first test that Hologic has introduced in the U.S. for post-transplant pathogen detection and monitoring on the company’s fully automated Panther system. This system also features tests for HIV-1, hepatitis C, and hepatitis B.

In addition to being approved by FDA, the Aptima CMV Quant assay is CE-marked for diagnostic and viral load monitoring use in Europe. For the future, Hologic also hopes to pursue regulatory approvals for other transplant assays that are currently in development for the BK virus and Epstein-Barr virus.

Health Canada Approves Panel for Rapid Molecular Bloodstream Infection Identification

BioMérieux’s Biofire Blood Culture Identification 2 (BCID2) panel has received Health Canada’s approval for identifying bloodstream pathogens, antimicrobial resistance genes, and other targets. The test is designed to accelerate sepsis diagnosis, which in turn will help clinicians to identify appropriate therapy for patients faster. According to Jessica Blavignac, director of Scientific and Medical Affairs of bioMérieux Canada, the new panel identifies pathogens up to 70% faster than other bloodstream infection tests. Additionally, it decreases optimal therapy initiation by 33.5 hours.

Biofire BCID2 tests for 43 bloodstream infection targets, including both gram-negative and gram-positive bacteria, yeast, and 10 different antimicrobial resistance genes. The test identifies all these targets from one sample, with results yielding in about an hour from positive blood culture. According to bioMérieux, the new panel has one of the broadest menus available today for a highly multiplexed syndromic panel, as it also covers respiratory, meningitis/encephalitis, and gastrointestinal syndromes.

Angle Earns FDA Clearance for Parsortix System

The Food and Drug Administration (FDA) has cleared Angle’s Parsortix system, a liquid biopsy for breast cancer patients. The test analyzes circulating tumor cells, in contrast to standard liquid biopsies, which analyze circulating tumor DNA. This enables the Parsortix system to provide a more complete picture of a patient’s cancer development, one that doesn’t just examine DNA, but also RNA, protein expression, and the cytology and morphology of the actual cancer cells. This also means that Parsortix results closely approximate the information obtained from metastatic tissue biopsies, and that the test can be used for repeat noninvasive biopsies to assess cancer status. 

Angle worked for 6 years to achieve FDA clearance for this test. Over that time, the company conducted validation studies on 300 metastatic breast cancer patients and several thousand healthy volunteer donors.

BD Gets CE Mark for SARS-CoV-2 and Influenza A/B Test

The BD SARS-CoV-2/Flu assay from Becton, Dickinson, and Company (BD) has been CE marked, making it the second test available on the BD Cor PX/MX system to receive this regulatory authorization. This new test is an automated, multiplexed real-time PCR assay that detects and differentiates SARS-CoV-2, influenza A, and influenza B from a single sample. It is intended for use in both symptomatic and asymptomatic patients.

The BD Cor PX instrument prepares samples for the BD SARS-CoV-2/Flu assay by performing the appropriate pre-analytical processing steps and automatically delivering the samples to the BD Cor MX instrument for molecular analysis. The BD Cor MX instrument then performs the extraction, amplification, and detection steps of the test.

Additionally, the BD Cor MX/PX system allows up to 1,700 specimens to be loaded at a time. It has an onboard capacity for reagents and samples that provides more than 6 hours of unimpeded system processing and up to 1,000 sample results in 24 hours.