Lybe Scientific, a startup commercializing nanoparticle-based technology developed at the Norwegian University of Science and Technology, has launched its first product with CE marking, the NAxtra nucleic acid extraction kit, a magnetic bead-based technology intended for viral RNA extraction from human nasopharyngeal and/or oropharyngeal swab samples. The kit should be used for the isolation and purification of viral RNA when preparing clinical samples for downstream molecular diagnostics, and is intended for use by clinical laboratory personnel specifically instructed and trained in magnetic bead-based nucleic acid purification and in vitro diagnostic procedures, the company said.
CareDx has launched AlloSure Lung. AlloSure, the company's donor-derived cell-free DNA test for noninvasive transplant surveillance, is available for assessing kidney and heart transplantation. It will now also be available for use in lung transplantation.
Versiti this week announced the creation of a new assay for transplant patients that detects and characterizes genomic loss of heterozygosity (LOH) in the human leukocyte antigen (HLA) region. The assay, from the Versiti Histocompatibility Lab, consists of flow cytometric enrichment of a patient's cancer cells, followed by genomic analysis. Versiti uses two separate genomic analysis methods to better ensure accurate detection of HLA LOH. The company has partnered with Seattle-based HematoLogics to identify and isolate abnormal cells in relapse samples via flow cytometry and cell sorting.
ImmunoIVD, a Stockholm-based diagnostic company specializing in severe combined immunodeficiency (SCID) newborn screening, has launched the CE IVD marked SPOT-it TREC & SMN1 Screening kit in the EU. The real-time qPCR assay is designed to simultaneously screen or SCID and spinal muscular atrophy (SMA) in newborns using DNA extracted from fresh, dried blood spots sampled on filter paper. The assay is based on the same plate-stacking procedure as the SPOT-it SCID screening assays, making it efficient and affordable for small to medium sized screening laboratories, a company spokesperson said. SCID screening is performed by semi-quantification of T-cell receptor excision circle, while SMA screening is performed through the qualitative detection of exon 7 of the SMN1 gene, according to the company's website.
Amprion, a San Francisco-based biomarker testing company, has launched the SynTap Biomarker test out of its San Diego CLIA lab. The laboratory-developed test is designed to detect a-synuclein aggregates, a hallmark in various brain diseases. As such, the assay aids in diagnosing synucleinopathies such as Parkinson's disease, Lewy body dementia, and multiple system atrophy. In addition, the test helps distinguish underlying synucleinopathies in other neurodegenerative conditions, such as Alzheimer's disease. Based on Amprion's proprietary Seed Aggregation Assay technology, SynTap identifies prion-like a-synuclein aggregates using approximately 100 µl of cerebrospinal fluid. Test results are intended to accompany other clinical and diagnostic findings for patient case management, the company said.
Meridian Bioscience launched its Air-Dryable Direct RNA/DNA qPCR Blood Mix, a master mix for developing room-temperature stable molecular diagnostic tests that directly amplify RNA from crude whole blood, serum, or plasma. The mix eliminates the need for an extraction step in a qPCR test by using specialized enzymes and an advanced buffer formulation pre-optimized specifically for whole blood, serum, and plasma. It was designed to be compatible with air-drying in an oven while maintaining the highest activity and sensitivity, bypassing the costs associated with cold storage or lyophilization, Meridian said.
SpeeDx has launched a SARS-CoV-2 variant genotyping assay designed to detect the Lambda variant. PlexPrime SARS-CoV-2 L452Q Lambda is a single-well mix designed to detect a spike mutation found in the C.37 variant of interest as well as an RdRp gene target of SARS-CoV-2. The reagent is the third product in the PlexPrime SARS-CoV-2 genotyping portfolio and can be used as a standalone reflex test or combined with PlexPrime SARS-CoV-2 Alpha/Beta/Gamma+ and PlexPrime P681R Delta. The assays are compatible with standard qPCR and liquid-handling instrumentation and can potentially reduce cost and manual steps in labs running high-volume sequence analysis, SpeeDx said.
Bio-Rad Laboratories has launched an enhanced version of its Exact Diagnostics RP Positive Run Control for syndromic respiratory panels. The new version contains inactivated whole SARS-CoV-2 virus. Intended to monitor the performance of clinical respiratory panel assays, the positive control set now contains a total of 23 respiratory analytes in a single vial and can be used to assess the entire molecular diagnostic process, including extraction, detection, and amplification.
Thermo Fisher Scientific has launched the MagMAX Wastewater Ultra Nucleic Acid Isolation Kit. The kit is meant to support the efforts of public health laboratories and researchers who have been developing SARS-CoV-2 surveillance methods using wastewater to help identify asymptomatic carriers on college campuses, monitor regional spread among communities, and capture emerging viral mutations, the company said.
The MagMAX Wastewater Ultra Nucleic Acid Isolation Kit is compatible with a range of input volumes from 200 µl to 500 mL, and works with various upfront concentration methods, including ultracentrifugation, precipitation, and filtration. For labs in need of an automated viral enrichment method, the MagMAX Wastewater Ultra Nucleic Acid Isolation Kit with virus enrichment uses Dynabeads technology to automate and streamline sample concentration.
Amprion has launched the SynTap Biomarker Test, a laboratory-developed test for the detection of a-synuclein aggregates, which is associated with a range of brain diseases. The test is for use in helping to diagnose synucleinopathies including Parkinson's disease, Lewy Body dementia, and multiple system atrophy. It can also help distinguish underlying synucleinopathies in other neurodegenerative diseases such as Alzheimer's disease. The test is based on Amprion's Seed Aggregation Assay, and it identifies prion-like a-synuclein aggregates in a few drops of cerebrospinal fluid. It is intended to be used with other clinical and diagnostic results to manage patients.