Datar Cancer Genetics Unveils Exacta AI: A Revolutionary AI-Driven Cancer Treatment Platform

Metropolis Healthcare Partners with Roche to Launch Self-Sampling HPV DNA Test for Cervical Cancer Screening in India

Union Budget 2025: Full Exemption from Basic Customs Duty (BCD) for 36 Lifesaving Drugs

Dr. Jitendra Singh Inaugurates Centre for Advanced Genomics & Precision Medicine at AIIMS Jammu

Union Budget 2025-26: Key Healthcare Measures for Cancer Care and Access to Life-Saving Drugs

FDA Approves Roche’s PATHWAY HER2 Test for Identifying HER2-Ultralow Breast Cancer Patients Eligible for ENHERTU

Bristol Myers Squibb’s Breyanzi® Receives CHMP Recommendation for Relapsed or Refractory Follicular Lymphoma in the EU

NHS to Offer Groundbreaking Gene Therapy for Sickle Cell Disease

Quibim Secures $50M Series A to Advance AI-Powered Imaging for Precision Medicine

Apollo Hospitals Unveils Advanced Oncology Facility in Chennai

Beckman Coulter’s Alzheimer’s Blood Test Receives FDA Breakthrough Device Designation

ANGLE Announces Breakthrough Dual CTC-DNA and ctDNA Analysis with Illumina’s NGS Solution

Diatech Pharmacogenetics and Merck Expand Collaboration to Enhance RAS Biomarker Testing in MEA Region

DCG Unveils AI-Powered Video-Reporting for Personalized Chemotherapy Selection

FDA Approves Monthly Maintenance Dosing for LEQEMBI® in Alzheimer’s Treatment

Home
/
update
/
details

Diasorin Secures FDA 510(k) Clearance for Enhanced Respiratory Panel

NextEdge Admin

17 May 2024

1 min 40 sec

Diasorin recently announced that the US Food and Drug Administration has granted 510(k) marketing clearance for their updated molecular respiratory panel, now including SARS-CoV-2 detection. The NxTag Respiratory Pathogen Panel v2, based in Saluggia, Italy, utilizes multiplex PCR to identify 19 viral and two bacterial targets in nasopharyngeal swab samples from patients displaying respiratory symptoms.

Designed for use with the Luminex Magpix instrument, capable of processing 96 specimens per run, the test employs ready-to-use lyophilized reagent wells. Enhancements in the v2 version aim to improve accuracy and user experience, featuring easier-to-identify plate seals. Alongside SARS-CoV-2, the panel identifies infections from other coronaviruses, flu A/B, respiratory syncytial virus, Chlamydia pneumoniae, and Mycoplasma pneumoniae.

Diasorin credits funding from the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) for the expanded panel’s development. Prior to Diasorin’s acquisition, Luminex had received approximately $5.4 million from BARDA in September 2020 to expand the NxTag RPP assay, enabling inclusion of SARS-CoV-2 and facilitating high-throughput COVID-19 testing.