Qiagen has launched the NeuMoDx MPXV Test Strip, a research-use-only multiplex assay that identifies both clades of monkeypox. The test comprises DNA extraction from lesion fluid swabs to isolate target nucleic acids followed by real-time PCR. It is designed as a dual-target assay to reduce false negatives, and provides results in about 70 minutes running on Qiagen's NeuMoDx and NeuMoDx 288 Molecular Systems. Test strips and core reagents and consumables are ready to use, can remain on board a NeuMoDx system for a minimum of seven days, and can be loaded while the system is operating, Qiagen noted.
Juno Diagnostics has launched Juno Hazel, a noninvasive prenatal screening test that uses blood from a finger prick. The assay makes use of JunoDx's proprietary sample collection kit and does not require phlebotomy. It tests for common chromosomal aneuploidies, including trisomy 21, 18, and 13, and promises greater than 99 percent sensitivity and specificity.
Bio-Rad Laboratories said this week that its Exact Diagnostics HBV, HCV, and HIV-1 Screen Controls are now available to laboratories in Europe after having received CE IVD marking earlier this year. These controls are designed to monitor the performance of blood donor screening assays, including extraction, amplification, and detection, and are calibrated against WHO International Standards for HBV, HCV, and HIV-1. The products are made of whole viruses in a high-quality citrate plasma matrix to ensure lot-to-lot reproducibility, have an 18-month shelf life from date of manufacture (when stored at -20° C or below), and have a 24-hour stability (when stored at 2-8° C).
Cepheid has launched its Xpert GBS LB XC test to qualitatively detect Group B Streptococcus (GBS) from enriched Lim broth cultures of patient samples. The new assay builds on Cepheid's previous Xpert GBS LB test launched in 2012 by adding another target. The new molecular test includes dual targets in highly conserved regions of the GBS genome to improve coverage and performance, Cepheid said in a statement. The test can provide positive results in 27 minutes and negative results in 43 minutes.
Cepheid has also launched its Xpert Xpress MVP test, a multiplexed PCR test to detect DNA from organisms associated with bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis from a single vaginal swab sample. The test returns results in an hour and runs on Cepheid's GeneXpert systems.
Sentinel Diagnostics has launched the fully automated SentiNat 200 sample-to-result system and Stat-Nat SN200 real-time PCR assays to quantitatively detect 10 viruses. According to the Milan, Italy-based firm, the products are for midsized to large laboratories that diagnose viral infections. SentiNat 200 is a compact platform for DNA/RNA extraction, PCR setup, and amplification. It contains two integrated thermal cyclers and FastFinder analysis software and can be used to perform a multiparametric analysis of up to 15 viruses in one run, Sentinel said, adding the assay can process as many as 48 samples in four hours.
Roche has announced a new name and brand for its at-home COVID-19 test -- the Pilot COVID-19 At-Home Test. The over-the-counter assay, which uses a nasal swab to detect the nucleocapsid protein of SARS-CoV-2, returns results in as few as 20 minutes and will be available at CVS, Amazon, and in the Optum Store, the company said. The lateral flow test is manufactured by SD Biosensor and distributed by Roche. It first received Emergency Use Authorization from the US Food and Drug Administration in December 2021. In a prospective clinical study, the test showed relative sensitivity of 93 percent and relative specificity of 100 percent.
Myriad Genetics launched UroSuite, a suite of prostate cancer genetic risk assessment tests. The suite includes the Polaris Prostate Cancer Test, MyRisk Hereditary Cancer Test, BRACAnalysis CDx, and Precise Tumor Molecular Profile Test. UroSuite enables providers to order multiple Myriad tests and receive a one-sheet summary of results through an online portal, use Myriad's Precise Treatment Registry health data platform, and connect with genetic counselors and clinical experts.
FIND has launched its publicly available and searchable directory of Ebola diagnostic tests. The directory is aimed at providing a central directory of tests for ebolavirus species detection outside the World Health Organization's and FIND's emergency use authorization lists. FIND noted that while many point-of-care and near point-of-care tests developed during the 2013-2016 West Africa Ebola epidemic were made for the Zaire ebolavirus, or ZEBOV, strain, a need to confirm the Sudan ebolavirus, or SUBOV, strain remains. The Geneva-based global diagnostic alliance invites diagnostic developers to submit details about their Ebola test for inclusion in the directory. Questions about submitting a test to the database can be sent here.
Bio-Rad Laboratories has launched two new Exact Diagnostics-branded products: CT/NG Positive Run Control and STI Negative Run Control for use with molecular assays to monitor their intra- and inter-run performance.
CT/NG Positive Run Control is intended to be used with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) molecular assays. It contains a mix of formalin-inactivated whole CT elementary bodies with heat-inactivated whole NG microorganisms and is formulated in a synthetic matrix. The product is internally value-assigned using Bio-Rad Droplet Digital PCR.
The STI Negative Run Control is a formulated synthetic matrix containing human cells. This simulates adequate specimen sampling, which is tested by some assays, Bio-Rad said. The product may also be used to dilute or spike-in patient specimens or analyte-containing materials for purposes such as assay validation and verification, the company added.
BioAro has begun marketing genetic and microbiome testing services. According to the company, Canadians can now order its genomic testing for various acquired health risks, which involves sequencing and analysis of approximately 20,000 genes. The company said in a statement that interested customers can order a collection kit online and either mail their sample back or drop it off at a BioAro laboratory. The firm has labs in Calgary, Alberta;, Vancouver, British Columbia; Winnipeg, Manitoba; and Toronto, Ontario, but is making sample collection kits available to customers across North America.