We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
ZeptoMetrix an Antylia scientific company

T2 Biosystems

T2 Biosystems, a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, is dedica... read more Featured Products: More products

Download Mobile App




Direct-From-Blood Molecular Diagnostic Test Detects Candida Auris in Just 3-5 Hours

By LabMedica International staff writers
Posted on 21 Jul 2023

Candida auris (C. More...

auris) is a fungal pathogen resistant to multiple drugs and is recognized as a significant worldwide health risk due to its high mortality rate of up to 60%. Its identification is challenging with conventional lab techniques, often leading to improper treatment. To reduce the burden of this fungal disease, public health officials are being urged to continue promoting the crucial benefits of early detection and appropriate treatment. Now, a direct-from-blood molecular diagnostic test can detect C. auris directly from blood in just 3-5 hours, eliminating the need to wait for several days for a positive blood culture.

T2 Biosystems’ (Lexington, MA, USA) C. auris direct-from-blood molecular diagnostic test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). This is the third product from T2 Biosystems to receive FDA Breakthrough Device designation after the company's T2Resistance Panel and T2Lyme Panel previously received the same designation. The company intends to expand its FDA-approved T2Dx Instrument's test options by including the C. auris diagnostic test, designed to detect C. auris directly from the blood within 3-5 hours, thus eliminating the days-long wait for a positive blood culture.

Currently, T2 Biosystems markets and sells the T2Candida Panel, the only FDA-approved diagnostic test capable of detecting sepsis-causing fungal pathogens directly from blood, thereby eliminating the need to wait for days for a positive blood culture. The T2Candida Panel, which runs on the fully automated T2Dx Instrument, can simultaneously detect five Candida species, including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata. Rapid detection of these pathogens, as well as C. auris, is critical to ensuring infected patients receive suitable antifungal therapy, enhancing clinical outcomes.

"We are pleased with the FDA’s decision to grant Breakthrough Device designation for our Candida auris test, which provides greater and more frequent access to the FDA and may accelerate our path to FDA clearance,” said John Sperzel, Chairman and CEO of T2 Biosystems. “We believe adding Candida auris to the test menu on our FDA-cleared T2Dx Instrument will provide clinicians with a valuable tool to rapidly detect a dangerous, multidrug-resistant fungal pathogen much faster than blood culture-based methods, strengthening our value proposition and increasing the attractiveness of our products to U.S. hospitals.”

Related Links:
T2 Biosystems 


Gold Member
Troponin T QC
Troponin T Quality Control
Verification Panels for Assay Development & QC
Seroconversion Panels
New
Clostridium Difficile Test
Immunocard Toxins A&B
New
mRNA Extraction Kits
TurboCapture mRNA Kits
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Clinical Chemistry

view channel
Image: The POC device rapidly predicts neonatal respiratory disease at birth in the NICU (Photo courtesy of SIME Diagnostics)

AI-Powered Lung Maturity Test Identifies Newborns at Higher Risk of Respiratory Distress

Each year, approximately 300,000 babies in the United States are born between 32 and 36 weeks' gestation, according to national health data. This group is at an elevated risk for respiratory distress,... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: The cancer stem cell test can accurately choose more effective treatments (Photo courtesy of University of Cincinnati)

Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer

Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more

Pathology

view channel
Image: A biomarker discovery pipeline has shown promise as a noninvasive method of diagnosing CRC (Photo courtesy of NCI Center for Cancer Research)

Machine Learning Tool Enables Noninvasive Diagnosis and Monitoring of Colorectal Cancer

Colorectal cancer (CRC) is the second leading cause of cancer-related deaths in the United States when considering both genders. Colonoscopy remains the gold standard for CRC diagnosis, but it is invasive,... Read more

Technology

view channel
Image: Scanning electron microscopy images showing 3D micro-printed Limacon-shaped whispering-gallery-mode microcavities with different amounts of deformation (Photo courtesy of A. Ping Zhang/PolyU)

Tiny Microlaser Sensors with Supercharged Biosensing Ability to Enable Early Disease Diagnosis

Optical whispering-gallery-mode microlaser sensors function by trapping light within tiny microcavities. When target molecules bind to the cavity, they induce subtle changes in the laser’s frequency, allowing... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.