CLN - Regulatory Roundup
Myriad Genetics’ My Choice CDx Test received Food and Drug Administration (FDA) approval as the companion diagnostic (CDx) for GSK’s polymerase (PARP) inhibitor Zejula (niraparib), which is intended for patients with advanced ovarian cancer.
The approval is based on final data from the PRIMA trial, which used the MyChoice CDx Test to determine homologous recombination deficiency (HRD) status and stratify advanced ovarian cancer patients. The test determines HRD status by leveraging next-generation sequencing technology to conduct a comprehensive assessment of BRCA1 and BRCA2 genes. The assessment offers information about large rearrangements and a tumor genomic instability score that includes loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions.
The MyChoice CDx is the only FDA-approved companion diagnostic test in the United States to identify patients with HRD-positive status (HRD+) who are eligible for treatment with Zejula.
Healthcare providers prescribe Zejula for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer that is associated with HRD+ status. That status is defined by a deleterious or suspected deleterious BRCA mutation or genomic instability. Patients receive Zejula after a complete or partial response to treatment with first-line platinum-based chemotherapy.
Nearly 50% of patients with advanced ovarian cancer have HRD+ tumors. Identifying these patients is critical to ensuring appropriate use of PARP inhibitor therapy and improving personalized treatment decisions, Myriad Genetics said.
MeMed recently announced Food and Drug Administration Breakthrough Device Designation for its investigational device MeMed BV Flex, designed to accurately distinguish between bacterial and viral infections based on the body’s immune response.
From just a few drops of capillary blood, the test measures multiple immune proteins and applies machine learning
algorithms to generate a clinically actionable score in 15 minutes. Running on the MeMed Key platform, the test is designed
for simplicity and intended for use across hospitals and CLIA-waived and decentralized care settings, pending regulatory clearance.
The test also expands accessibility, particularly for children and older people, while delivering accuracy traditionally limited to central laboratory infrastructure, MeMed said.
Qiagen’s QIAstat-Dx Gastrointestinal (GI) Panels on the QIAstat-Dx Rise automated syndromic testing system recently got Food and Drug Administration (FDA) clearance, the company said.
Laboratories now can run both QIAstat-Dx respiratory and QIAstat-Dx GI panels on QIAstat-Dx Rise, the high-throughput version of the QIAstat-Dx system. Both versions support comprehensive syndromic testing with panels designed to detect multiple pathogens associated with similar symptoms in a single test, and targeted mini panels that focus on a defined group of pathogens.
The FDA clearance includes the QIAstat-Dx GI Panel 2, which detects 16 bacterial, viral, and parasitic pathogens from a single stool sample. The pathogens include clinically relevant Shiga toxin-producing E. coli (STEC) subtypes such as stx2f. The clearance also includes QIAstat-Dx GI Panel 2 Mini B and Mini B&V, which provide targeted detection of five GI pathogens, including STEC.
QIAstat-Dx Rise automates cartridge loading and unloading and can process up to 160 tests per day. Laboratories can run 16 samples in a batch while maintaining dedicated urgent slots for high-priority samples.
Meridian Bioscience recently announced that a broad portfolio of its Alethia molecular assays achieved CE marking under the European In Vitro Diagnostic Regulation (IVDR).
The certification gives IVDR Class C certification to Alethia Pertussis and Alethia Pertussis External Controls, Alethia GBS and Alethia GBS External Controls, Alethia CMV and Alethia CMV External Controls, Alethia Malaria and Alethia Malaria External Controls, Alethia Chlamydia, Alethia Gonorrhea, and Alethia HSV 1&2 and Alethia HSV 1&2 External Controls.
The IVDR represents a significant evolution in the European regulatory framework for in vitro diagnostics and introduces more rigorous requirements for clinical evidence, performance evaluation, quality systems, and post-market surveillance. Achieving IVDR certification underscores Meridian Bioscience’s commitment to delivering high-quality, compliant diagnostic solutions to laboratories and healthcare providers across Europe, the company said.
LEX Diagnostics received Food and Drug Administration (FDA) 510(k) clearance and CLIA-waived status for its VELO system, an ultra-fast point-of-care molecular diagnostics platform designed to deliver highly sensitive PCR results for key respiratory pathogens directly from a swab sample in under 10 minutes.
Among the respiratory pathogens supported by the LEX multiplex system are influenza A, influenza B, and SARS-CoV-2. The system can be integrated into point-of-care clinical workflows across primary care settings, urgent care clinics, pharmacies, physician office laboratories, and decentralized acute settings, the company said. The system’s proprietary cartridge-based design eliminates the need for external liquid handling and promotes ease of use and reliability.
LEX completed clinical studies in the United States with the VELO system and the influenza and SARS-CoV-2 assay during the 2024-2025 respiratory season.
Biocartis recently announced that its Idylla CDx MSI Test received Class C companion diagnostic (CDx) certification under the European Union’s In Vitro Diagnostic Regulation as a CDx for colorectal cancer (CRC).
The test is indicated as an aid to identify adult patients with microsatellite instability-high (MSI-H) metastatic CRC who may benefit from treatment with nivolumab in combination with ipilimumab. Designed for use on the Idylla platform, the Idylla CDx MSI Test qualitatively detects MSI-H/microsatellite stable in CRC tissue samples within a single-use cartridge and requires less than 3 minutes of hands-on time. The test and platform deliver results in under 3 hours, Biocartis said.
The test is commercially available in the United States and soon will be available in Europe.