New Products

Roche subsidiary Foundation Medicine has launched its FoundationOne Monitor test for research use in retrospective studies. The tissue-naive circulating tumor DNA monitoring assay is available for biopharmaceutical customers and uses the firm's ctDNA tumor fraction biomarker. The test quantifies ctDNA tumor fraction at each timepoint and offers molecular response insights to complement standard imaging in early-phase clinical research, the company said. It can also assess resistance to therapy across more than 300 genes. The assay is currently in development for clinical use.

BostonGene has launched its CLIA-certified and CAP-accredited liquid biopsy, immunoprofiling, and spatial proteomics solutions that the company said provide a "holistic" view of a patient's disease by integrating multiple AI-based molecular and immune profiling techniques. The liquid biopsy solution offers high-sensitivity pan-cancer interrogation of 216 genes, including 200 genes with complete exonic coverage, the company said. The company's proprietary error reduction algorithms and filtration of hematopoietic (CHIP) mutations provide accurate testing results, it added. The immunoprofiling solution uses a single tube of blood to identify surrogate biomarkers for clinical trial patient selection, monitor disease progression and treatment response, and guide immunotherapy treatment, BostonGene said. The spatial proteomics offering comprises a multiplex immunofluorescence assay to provide a comprehensive overview of tumor cells, active and suppressive immune cell infiltration, stromal and vascular components, and advanced analytics of tissue architecture based on cell-to-cell interactions, the company said.

Myriad Genetics said that it has added folate receptor alpha (FRα) to its Precise Oncology Solutions portfolio. The new biomarker adds a companion diagnostic option for healthcare providers to help guide treatment decisions for patients with ovarian cancer. FRα establishes patient eligibility for Immunogen's Elahere(mirvetuximab soravtansine-gynx), the only US Food and Drug Administration-approved drug for patients who are FRα-positive and resistant to platinum-based chemotherapy. FRα is a newly recommended biomarker test included in the National Comprehensive Cancer Network treatment guidelines for ovarian cancer, Myriad noted. The new biomarker can be ordered from Myriad alongside other companion diagnostic tests, and oncologists can also choose to receive germline, HRD, FRα biomarker, and tumor testing results from a single laboratory.

Labcorp has launched its Plasma Focus liquid biopsy test, which analyzes cell-free DNA to enable targeted therapy selection for patients with advanced or metastatic solid tumors. The test in intended for use in patients with non-small cell lung, colorectal, breast, esophageal, gastroesophageal junction, and gastric cancers, and melanoma, and is meant as a complement to tissue-based genomic testing, particularly when tissue is not available or accessible. It uses next-generation sequencing for the detection of genomic sequence mutations in 33 clinically actionable or relevant genes, including amplifications in eight genes, translocations associated with five genes, and microsatellite instability.

Blood health company Versiti has launched its Anti-von Willebrand Factor Antibody Assay to help clinicians identify patients suspected of having acquired von Willebrand disease, a rare bleeding disorder. The test detects both inhibitory and non-inhibitory antibodies that bind von Willebrand factor (VWF), in contrast to the von Willebrand factor inhibitor assay that is unable to rule out an anti-VWF antibody, the company said in a statement. The new test can help determine whether a patient has acquired von Willebrand disease due to an autoimmune mechanism, which can guide treatment plans. The assay may also be used for patients with type 3 von Willebrand disease that are suspected of developing an antibody to VWF replacement therapy.

Simple HealthKit, a Fremont, California-based clinical diagnostic laboratory, has launched an expanded at-home sexual health kit for five common sexually transmitted infections: chlamydia, gonorrhea, and trichomoniasis (tested via molecular methods); and HIV and syphilis (tested via enzyme immunoassay). Users submit a self-collected finger stick and urine sample to the company's CLIA-certified labs, where tests are processed within 24 hours of receipt. The company includes a telehealth visit and aftercare for those who test positive for one or more conditions. The test is $99.99 and is not available in New York State, according to the company's website.

A. Menarini Diagnostics has launched the Prime MDx platform, a sample-to-result, all-in-one, fully-automated molecular diagnostics platform for real-time PCR testing. The system allows users to process a range of sample types using pre-filled plates together with a universal extraction solution. It enables them to run up to five different assays per sample with a maximum capacity of 240 samples per day, and includes AI-driven software for continuous sample loading to result interpretation. Prime MDx will be launched with a viral upper respiratory-tract infections panel and a viral transplant infections panel for a broad spectrum of sample matrices. Other testing panels are currently in development.

Siemens Healthineers has launched its Atellica 570 Analyzer and Atellica HEMA 580 Analyzer for high-volume hematology testing. The automated instruments provide complete blood count results with throughput of up to 120 tests per hour. The company said the instruments reduce daily maintenance, support rapid reagent changes, employ advanced data management capabilities to help provide consistent interpretations of results, send normal results to laboratory information systems, flag and code abnormalities that require a technician's evaluation, and provide guidance on follow-up steps such as dilution or slide reviews. The 570 instrument measures 43 cell parameters and the 580 instrument measures 55, including immature red blood cell indicators. Up to six of the 570 and 580 instruments can be integrated to increase throughput with automated workload balancing and reflexive testing with minimal operator involvement, the firm said.

Danaher subsidiary Beckman Coulter Diagnostics has launched its DxI 9000 Access Immunoassay Analyzer, which can run up to 215 tests per hour per square meter. The analyzer doesn't require daily maintenance and uses the firm's PrecisionVision machine vision technology, which relies on multiple cameras with defined algorithms to to detect processing errors in real time, the company said. The automated safeguards included with PrecisionVision are tube identification, cap detection, tip check, sample aspiration, and delivery, residual wash volume, and substrate volume. The analyzer also uses the firm's DxS IntelliServe remote service solution to monitor data and error trends and identify service experts to resolve issues with remote operation and troubleshooting, Beckman Coulter said.

The analyzer is currently available in most countries worldwide.

Grifols has launched in the US its AlphaID At Home over-the-counter genetic test for alpha-1-antitrypsin deficiency (alpha-1), a protein deficiency that can result in chronic obstructive pulmonary disease. The firm is providing for free its PCR-based AAT test that uses cheek swab samples and laboratory testing to identify 14 genetic variants in the serpin peptidase inhibitor class A member 1 (SERPINA1) gene. The firm received US Food and Drug Administration 510(k) clearance for the test in November 2022.