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New Products

Amoy Diagnostics AmoyDx Pan Lung Cancer PCR Panel

Amoy Diagnostics and Premia have launched the AmoyDx Pan Lung Cancer PCR Panel in Japan as a reimbursed companion diagnostic for multiple anti-cancer agents. The panel was conceived by AmoyDx, who also manufactures it, and developed in Japan by Premia. It uses real-time PCR to evaluate 11 driver genes. In Japan, the use of five driver genes on the panel has been approved as a companion diagnostic for 10 targeted therapies for non-small cell lung cancer.

Roche Cobas Infinity Edge

Roche has launched its Cobas Infinity Edge cloud-based platform that connects patient test results, medical records, and third-party applications to allow clinicians to monitor patient health and adjust treatment protocols. The software suite is designed as an open platform for point-of-care healthcare providers to be able to adopt third-party digital tools from Roche's digital marketplace. Test results can be integrated into a patient's electronic medical record and new applications can be deployed in a POC device, such as a glucose meter. Testing devices can also be installed and managed remotely using the software.

Roche is launching the test in select markets and plans to expand commercial availability globally throughout 2022 and 2023.

Centogene CentoCloud

Centogene has released CentoCloud, a software-as-a-service platform for the decentralized analysis, interpretation, and reporting of genomic variants linked to rare diseases. CentoCloud uses next-generation sequencing data from laboratories for automated, curated, bioinformatic analysis and AI-based variant prioritization and classification, followed by reporting. Results from consented data will also be used to augment Centogene's rare disease-focused bio/databank.

Hologic Panther Trax for High-Volume Molecular Testing

Hologic has launched Panther Trax, the latest addition to its Panther Scalable Solutions portfolio, making it available in several countries and regions. Panther Trax enables lab automation by physically linking multiple Panther instruments into a single workcell. It enables high-volume molecular testing and an increase of testing volumes without increasing staff. With it, labs can customize configurations to meet space constraints and minimize facility costs, the firm said. Panther Trax is now listed as a Class I medical device with the US Food and Drug Administration; CE-marked for diagnostic use in Europe; and will also be commercially available in Canada, Australia, and New Zealand.

AusDiagnostics Puryx Access

AusDiagnostics has launched Puryx Access for high-throughput nucleic acid extraction. Puryx Access was developed as a convenient, faster option for customers who need to purify nucleic acids from 96 samples simultaneously with minimal setup time and less training, the firm said. It can be automated on the company's new MT-Prep Access instruments, which can process 96 samples in 30 minutes.

Personalis NeXT Personal

Personalis has launched NeXT Personal, a tumor-informed liquid biopsy assay designed to detect and quantify molecular residual disease and recurrence in patients previously diagnosed with cancer. The assay boasts sensitivity down to the 1 part-per-million range and uses whole-genome sequencing of a patient's tumor to identify up to 1,800 somatic variants that are subsequently used to create a personalized liquid biopsy panel for each patient. 

With broader content than other available assays, these panels can also be used to detect clinically relevant alterations with a potential impact on therapeutic decision-making. Personalis said NeXT Personal is currently for research use only and that it plans to release it as a clinical test next year. 

Bionano Genomics: BioDiscovery NxClinical Software Version 6.1

Bionano Genomics has released version 6.1 of BioDiscovery's NxClinical software.

The upgrade comes with expanded capabilities for next-generation sequencing data in genetic diseases and cancer and could improve the ability to detect more clinically relevant variants. It includes uniparental disomy functionality and an expanded sequence knowledge base for visualization and reporting of relevant genomic variants.

The firm has streamlined data interpretation by automatically calculating the relevance for many of the evidence categories described by the American College of Medical Genetics technical standards for copy number variant interpretation, which can simplify data interpretation and reduce time to reportable result.

Fulgent Genetics HelioLiver

Fulgent Genetics has announced the commercial launch of its HelioLiver assay. The multi-analyte blood test incorporates cell free DNA methylation patterns and serum protein markers for the detection of hepatocellular carcinoma. The firm said HelioLiver can detect HCC at its earliest stages when lesions are still small.

GenDx NGStrack, TRKengine for chimerism monitoring

Genome Diagnostics (GenDx) has launched its NGStrack reagents and TRKengine software for monitoring chimerism in a recipient after a stem cell transplant by next-generation sequencing. NGStrack uses 32 indel markers to distinguish between donor and recipient, which cover 362 nucleotide positions across 18 chromosomes, and only requires small amounts of DNA. The TRKengine software interprets the markers and determines the percentage of chimerism. The products are compatible with Illumina sequencing platforms.

PerkinElmer PKeye Workflow Monitor

PerkinElmer has launched the PKeye Workflow Monitor, a cloud-based platform for laboratory personnel to remotely monitor and manage their PerkinElmer instruments and workflows in real time. PKeye Workflow Monitor allows users to receive notifications via email or texts to inform them of the start, stop, and completion of operations. It will also notify them if manual intervention is needed and can currently facilitate visual monitoring of the PerkinElmer Janus G3, Sciclone G3, and Zephry G3 workstations. It is also compatible with the firm's LabChip GX Touch instrument and the Chemagic 360 platform.