FDA Clears QIAGEN Bloodstream Infection Panel
QIAGEN has received FDA clearance for its QIAstat-Dx BCID GPF Plus AMR Panel, enabling detection of 20 pathogens and 10 antimicrobial resistance markers from positive blood cultures in about one hour.
Tag: molecular diagnostics
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OnsiteGene Introduces Handheld 10-Minute Real-Time PCR Instrument
OnsiteGene has unveiled myNAT, a handheld, battery-powered real-time PCR instrument capable of 40-cycle runs in under 10 minutes, with a target cost of under $5 per test, according to the company.
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Cepheid Introduces Third-Generation GeneXpert Molecular Testing System
Cepheid will debut its third-generation GeneXpert molecular testing system at ADLM 2024, featuring a touchscreen interface, updated software, and continued support for FDA-cleared tests and existing laboratory workflows.
Study Supports Multi-Omic Blood Test Strategy for Ovarian Cancer Detection
Researchers identified coordinated lipid, metabolite, and protein signatures in symptomatic patients, supporting a multi-omic strategy for earlier ovarian cancer detection.
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Roche Develops Rapid PCR Test for Rare Ebola Bundibugyo Virus
Roche has developed a rapid PCR assay for the rare Ebola Bundibugyo virus, enabling research-use detection within six days to support outbreak response in Central and East Africa, according to the company.
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Roche Introduces Automated Test for Hepatitis D Virus
The fully automated, high-throughput assay for Hepatitis D virus RNA is available on cobas 5800/6800/8800 systems in CE mark-accepting countries.
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Freenome Reports Clinical Validation Results for Updated Colorectal Cancer Blood Test
Freenome’s updated SimpleScreen CRC blood test met all primary and secondary endpoints in clinical validation, with improved sensitivity for precancerous lesions and colorectal cancer.
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Blood Test Finds Hidden Pancreatic Cancer After Treatment
A highly sensitive blood test for KRAS mutations detected pancreatic cancer recurrence in more patients than standard methods, according to Northwestern Medicine research.
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FDA-Approved PTEN Companion Diagnostic Becomes Available for Prostate Cancer Patients
NeoGenomics has launched the first FDA-approved PTEN IHC companion diagnostic for prostate adenocarcinoma, enabling identification of patients with PTEN deficiency who may benefit from AstraZeneca’s capivasertib therapy.
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Quest Diagnostics Integrates Oncology Tests into Electronic Health Record Platform
A pilot program with American Oncology Network allows clinicians to order molecular tests and receive results within their existing workflow.
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Bio-Rad Releases New Quality Control Kits for Cell and Gene Therapy
Bio-Rad has launched Vericheck ddPCR kits for quality control in cell and gene therapy manufacturing, offering validated workflows for mycoplasma detection, capsid analysis, and residual DNA quantification.
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WHO Adds First Diagnostic Test for Ebola Bundibugyo Virus to Emergency Use Listing
WHO has added the first molecular diagnostic test for Ebola Bundibugyo virus to its Emergency Use Listing, aiming to support rapid infection confirmation and surveillance during the ongoing outbreak in Central Africa.
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Study Shows Molecular Test Improves Treatment Accuracy for Vaginal Infections
A randomized trial found Cepheid’s Xpert Xpress MVP test improved appropriate treatment rates for vaginitis within 24 hours compared to standard diagnostic methods.
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Caris Life Sciences Launches New Blood Test for Early Cancer Detection
The test utilizes genomic sequencing and AI to identify biological signals associated with early-stage disease.
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Colombia Approves CRISPR-Based Blood Test for Tuberculosis
IntelliGenome receives regulatory clearance and partners with Velez Lab for distribution of its molecular diagnostic assay.
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Test Outperforms Traditional Tool in Predicting Melanoma Spread to Lymph Nodes
A prospective study shows the test more accurately identifies patients who may safely avoid biopsy compared to the Melanoma Institute Australia nomogram.
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InterVenn, Aranscia Expand Access to Blood-Based Ovarian Cancer Test
The expanded commercialization agreement aims to increase availability of the GlycoKnow Ovarian laboratory-developed test through Aranscia’s clinical workflow and technology platforms.
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bioMérieux Seeks FDA Clearance for Updated Gastrointestinal Testing Panels
The new molecular panels are designed to detect up to 22 pathogens in one hour with enhanced norovirus detection.
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