Sysmex Inostics has launched its HPV-SEQ next-generation sequencing test for measuring HPV DNA in the plasma of patients with HPV-related cancers. The test measures HPV 16 and HPV 18, two of the most common high-risk HPV strains. To assess its future utility in guiding treatment de-escalation strategies, HPV-SEQ has been employed to evaluate levels of circulating HPV alongside the radiographic assessment of therapy response in patients.
Avellino Lab has launched AvaGen, a test that assesses risk for keratoconus and other corneal distrophies, with full nationwide availability in the US. According to the company, the test examines more than 2,000 variants in 75 keratoconus-related genes. The assay reports a keratoconus risk score that is intended to inform decisions around the use and timing of US Food and Drug Administration-approved cross-linking treatment, which can halt disease progression and preserve vision. AvaGen results can also influence an eye care professional's choice of refractive surgery options.
For corneal dystrophies, the test determines the presence of any of the 70 TGFBI gene variants and provides a conclusive diagnosis of corneal dystrophy subtypes, such as epithelial basement membrane, granular and lattice disease distinctions, Reis-Bucklers, Schnyder and Theill-Behnke.
Invitae said it has begun offering its Personalized Cancer Monitoring (PCM) platform as a laboratory-developed test within an early access program for academic and pharmaceutical researchers. The test for detecting minimal residual disease and monitoring cancer recurrence involves whole-exome sequencing a patient's tumor biopsy and blood sample to select 50 variants that can "fingerprint" the tumor, the company said in a statement. These variants are then included on a personalized ctDNA panel that can be used longitudinally to gauge how well the patient's tumor has responded to treatment or for signs of cancer recurrence. Invitae will perform the test in a centralized lab in Iselin, New Jersey, with the goal of detecting residual disease or cancer recurrence before standard of care methods, such as imaging.
Centogene has launched New CentoXome, a whole-exome sequencing test that the company claims increases diagnostic yield by up to 20 percent compared to conventional WES assays. The test offers enhanced coverage of the exome, mitochondrial genome, and medically relevant genes and variants. It also has improved clinical reporting based on bioinformatics, artificial intelligence, and analysis of Centogene's database by medical experts, according to the firm.
Diazyme has launched an enzymatic BHB Assay for the quantitative determination of beta-hydroxybutyrate in human serum or plasma. The assay is a dual vial liquid-stable reagent used with clinical chemistry analyzers. Healthcare professionals use measurements of BHB and blood glucose to assess the severity of diabetic coma. They use BHB measurements to guide the monitoring of patients, who are taking insulin therapy, for diabetic ketoacidosis, and for the testing of patients who present to the emergency room with documented hypoglycemia, acidosis, alcohol ingestion, or an unexplained increase in the anion gap.
Novacyt has launched VersaLab Portable, an eight-piece portable molecular testing lab in a lightweight carrying case for rapid-turnaround and on-site PCR testing, initially COVID-19 testing. The system includes Novacyt's PROmate rapid direct-to-PCR COVID-19 assay running on the Genesig q16 PCR instrument, which can provide results in under 80 minutes with just a single pipetting step. The portable lab also provides a Bluetooth barcode scanner, adjustable pipette, vortex mixer, sample tube rack, magazine rack, pipette tips, and 8-GB memory stick, according to the company's website. Novacyt said that VersaLab Portable includes all equipment required to provide near-patient PCR testing using the PROmate workflow in non-clinical settings such as offices and workplaces.
MicroGen Diagnostics (MicroGenDx) has released the OrthoKey and OrthoKey Surgery workflows for diagnosing orthopedic infections.
OrthoKey integrates synovial fluid analyses for biomarkers and white blood cell count with other parameters needed to diagnose periprosthetic joint infections based on International Consensus Meeting diagnostic criteria. This evidence-based, algorithmic approach provides clinicians with the likelihood of infection with additional guidance on antimicrobial treatment through the analysis of 17 antimicrobial resistance genes, the company said. OrthoKey offers comprehensive, actionable diagnostic information in one to two days, followed by NGS identification of causative bacteria and fungi in three to five days, the company said.
OrthoKey surgery comprises the same workflow but includes the CaptiGen flat swab for absorption of microbial DNA, biofilm retrieval, and nucleic acid extraction.
Precipio launched a new HemeScreen panel for acute myeloid leukemia that returns results in four hours and determines the genetics of the disease. The test is intended to be used at oncology physician office laboratories and uses a single-sample plate to test blood samples for a variety of genes related to AML. It tests for FLT3, which can indicate how aggressive the disease is; CEBPA, which can provide prognostic information; NPM1, which can serve as a monitoring tool for minimal residual disease; IDH1, which is associated with decreased complete remission and IDH2 which is often associated with IDH1; and KIT, which reveals a poor prognosis and need for more aggressive treatment.
Meridian Bioscience has launched the Lyo-Ready DNA LAMP Mix to accelerate the development of ambient temperature-stable loop-mediated isothermal amplification assays. The new mix is formulated for rapid, robust, and sensitive DNA amplification through nucleic acid strand displacement, Meridian said. Its glycerol-free, 4x concentration format contains pre-optimized lyo-excipients. Once target-specific primers/probes are added, he mix is ready to be lyophilized, making it ideal for faster development LAMP assays, the company said.
Centogene has released CentoMD 6.0, a new version of its rare disease mutation database. The latest update includes more than 465,000 patients from 120 countries, with more than 225,000 linked to Human Phenotype Ontology (HPO) terms. It contains more than 31 million unique variants, an increase of 150 percent since the last release. The number of classified and curated variants has grown to 145,000, of which about 65 percent were previously unpublished. CentoMD 6.0 also features an updated variant classification tool that follows ACMG guidelines, visualized branching structure for HPO parent and child terms, and an integrated module to show individuals who have undergone biochemical testing.