Becton Dickinson CPO Detect Test

Exagen launched the Avise Vasculitis AAV test panel of individual analytes to assess and monitor anti-neutrophil cytoplasmic antibody-associated vasculitis. ANCA-associated vasculitis is characterized by vascular inflammation and damage, and early symptoms of the disease vary widely. Exagen's test is intended for use in patients suspected of small vessel diseases, such as granulomatosis with polyangiitis, microscopic polyangiitis, and eosinophilic granulomatosis with polyangiitis. 

Bio-Rad Laboratories has launched the StarBright Violet 515 (SBV515) dye, the first of a new range of fluorescent nanoparticles for flow cytometry. SBV515 has an excitation maximum at 401 nanometers and emission maximum of 516 nanometers, offering improved brightness to better resolve rare and low antigen density populations. It has a narrow emission profile to reduce spillover into neighboring filters and minimize excitation by other lasers, making it suitable for inclusion in multicolor panels. The dye is not susceptible to photobleaching, delivers high lot-to-lot reproducibility, and is stable at 4° C with no loss of signal, Bio-Rad said.

Everlywell has launched Current, a membership program for sexually transmitted disease testing. For $14.99 per month, members can get tested for one STD of their choice each month. Tests are sent to members with instructions and materials to collect their samples, which are then sent to a CLIA-certified lab. The physician-reviewed results are sent to subscribers in a few days, and if a test result is positive, an Everlywell physician from a third-party telehealth network will contact the patient to discuss next steps and prescribe treatment, if necessary.

Bionano Genomics' recent acquisition Lineagen has launched the EpiPanel Dx Plus, a laboratory-developed test for epilepsy-related conditions.

The proprietary gene panel is based on 223 genes selected from a literature review, including genes with pathogenic variants identified in more than 2,000 epileptic patients tested by Lineagen. The test is designed for patients who have experienced seizures, infantile spasms, encephalopathy, or febrile seizures and can predict the recurrence risk for other members of the family and allows for personalized treatment. It has an expected diagnostic yield of 30 percent.

Castle Biosciences has launched DecisionDx-SCC, its prognostic gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC). DecisionDx-SCC is a qRT-PCR assay of 40 genes that uses a neural network algorithm to classify individual risk of squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A, or 2B risk category, predicts individual metastatic risk to inform risk-appropriate management.

Opko Health's BioReference Laboratories announced the launch of its next-generation sequencing assay OnKoSight Advanced, which enables DNA mutational profiling of tumor samples. The test, developed by BioReference's specialty oncology division GenPath, offers targeted gene content aligned with recent National Comprehensive Cancer Network and World Health Organization guidelines. The panels include key biomarkers, such as tumor mutation burden and tumor-only microsatellite, and are tumor-type specific. They are also "optimized to exclude extraneous gene content," the company said.  

Centogene has released an update to its curated rare disease mutation database, CentoMD 5.8. This latest version includes more than 12.7 million unique variants, greater than 81,000 classified and curated variants, and over 199,000 individuals linked to HPO terms. Since December 2019, the number of cases in CentoMD has grown to more than 430,000, covering more than 120 countries.