Sangamo Therapeutics and Astellas Collaborate on Innovative Gene Therapy for Neurological Diseases

FDA Clears IND for Arbor Biotechnologies’ ABO-101 Gene Editing Therapeutic for Primary Hyperoxaluria Type 1

Fortis Healthcare Acquires Stake in Agilus Diagnostics

FDA Approves BRAFTOVI® Combination Regimen as First-Line Treatment for BRAF V600E-Mutant Metastatic Colorectal Cancer

The Role of Big Data in Precision Medicine

Caris Life Sciences Celebrates 1,000+ Precision Medicine Studies, Advancing Cancer Research and Patient Outcomes

OncoHelix and Qualisure Diagnostics Partner to Bring Thyroid GuidePx® Test to Canadian Patients

Gates Foundation Invests $50 Million in Tessera Therapeutics to Advance Gene Therapy for Sickle Cell Disease

FDA Approves Ensartinib (Ensacove) as First-Line Treatment for ALK-Positive NSCLC

Guardant Health and Boehringer Ingelheim Collaborate to Advance Liquid Biopsy CDx for HER2-Targeted Therapy in NSCLC

Cartherics Receives $300K G-Rex Grant to Advance Cancer Cell Therapy Manufacturing

Roche Revolutionizes Mass Spectrometry Diagnostics with Launch of cobas® Mass Spec Solution

Complete Genomics Partners with Eurofins Clinical Enterprise to Expand Sequencing Service Offerings

NeuroKaire Secures $10M to Transform Precision Medicine in Psychiatry and Neurology

Redcliffe Labs Announces Leadership Transition to Drive Healthcare Accessibility

Home
/
update
/
details

Diasorin Secures FDA 510(k) Clearance for Fungemia Panel

NextEdge Admin

06 Jun 2024

2 min 32 sec

healthcare,syndromic panel,antimicrobial stewardship

Diasorin, headquartered in Saluggia, Italy, recently obtained 510(k) clearance from the US Food and Drug Administration for its Liaison Plex Yeast Blood Culture Assay, a molecular test designed to detect common fungal bloodstream infections. This assay targets 16 pathogens frequently associated with fungemia, a condition of great concern due to its potential transmission between patients in healthcare settings.

This marks Diasorin's second syndromic panel to receive clearance for use on the Liaison Plex instrument, following the Liaison Plex Respiratory Flex Assay. The company is also in the process of developing Gram-positive and Gram-negative blood culture panels to aid in diagnosing bloodstream infections on the same instrument.

Angelo Rago, president of Diasorin's Luminex business, highlighted the significance of the Liaison Plex Yeast Blood Culture Assay in addressing the critical need for rapid diagnosis of fungal infections, thus facilitating better patient outcomes. Diasorin CEO Carlo Rosa affirmed the company's dedication to expanding its multiplex test offerings on the Liaison Plex system.

In March, Diasorin had announced the clearance of the Liaison Plex platform for syndromic testing. This system incorporates a flexible pricing model, allowing users to pay for either specific results or the entire panel. It supports both direct DNA detection and PCR amplification methods and serves as a replacement for the Verigene sample-to-answer benchtop instrument, acquired by Diasorin through its 2021 purchase of Luminex. The clearance of the Liaison Plex Yeast Blood Culture Assay further solidifies Diasorin's commitment to advancing diagnostic capabilities and enhancing antimicrobial stewardship in clinical laboratories and healthcare systems across the United States.