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
Sign In
Advertise with Us
Technopath Clinical Diagnostics

Download Mobile App




Events

ATTENTION: Due to the COVID-19 PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event.

Next Generation Rapid Antibiotic Susceptibility Testing (AST) Platform Granted FDA Breakthrough Device Designation

By LabMedica International staff writers
Posted on 05 Oct 2021
Print article
Image: Next Generation Phenotyping Platform from Selux (Photo courtesy of Selux Diagnostics, Inc.)
Image: Next Generation Phenotyping Platform from Selux (Photo courtesy of Selux Diagnostics, Inc.)

Selux Diagnostics, Inc.’s (Boston, MA, USA) Next Generation Phenotyping (NGP) platform has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for positive blood culture and sterile body fluid samples.

Selux NGP is the only single-platform technology capable of delivering rapid AST results across all sample types with an unprecedented antibiotic menu. Selux's NGP technology delivers phenotypic AST from both Positive Blood Bottles and isolated colonies - which may provide actionable results to indicate which therapies may effectively treat a patient's infection. The proprietary Selux technology uniquely provides targeted therapy results days faster than the current standard of care providing actionable information to inform patient treatment for all Infectious Diseases. Selux's NGP platform provides unprecedented speed-to-results and breadth of menu while meeting the accuracy, throughput, and cost effectiveness requirements of clinical microbiology laboratories and integrated healthcare systems.

"While currently under review for our rapid antimicrobial susceptibility test (AST) system for isolated bacterial colonies, the FDA recognized the urgent need to perform AST directly from blood and other sterile body fluids by granting us Breakthrough Designation," said Steve Lufkin, CEO of Selux. "The NGP technology is uniquely positioned to accelerate personalized therapy selection for patients while leading the fight against antibiotic resistance. We are honored by the FDA recognition of the Selux platform for these sample types."

"Today's delay of as much as 4+ days before AST results are available for the sickest patients is not optimal. The Selux platform is capable of testing up to 40 drugs in parallel, with room to expand as new therapies become available," added Lufkin "Providing more rapid results for patients with drug resistant infections may allow Physicians to prescribe targeted antimicrobial therapy much sooner, reducing hospital length of stays and help combat drug resistance."

Related Links:
Selux Diagnostics, Inc. 

Gold Supplier
SARS-CoV-2 S-IgG Antibody Assay
Lumipulse G SARS-CoV-2 S-IgG
New
Flu A/B Antibodies and Antigens
HyTest Flu A/B Antibodies and Antigens
New
Cytology Sample Processor
SDSCP9000 CytoPath Processor
New
Tuberculosis (TB) Test
QIAreach QuantiFERON-TB

Print article

Channels

Molecular Diagnostics

view channel
Image: Absence of nuclear immunohistochemical staining of MSH2 protein (A) and presence of MLH1 protein (B) in urothelial cell carcinoma of the urinary bladder of a patient carrying a germline MSH2 mutation. Observe the nuclear staining in stromal cells as an internal control (Photo courtesy of Radboud University Nijmegen Medical Centre)

Simple Urine Test Detects Urothelial Cancers in Lynch Syndrome Patients

Lynch Syndrome (LS) is an inherited genetic disorder that carries a high risk of cancer. LS is caused by mutations affecting MLH1, MSH2, MSH6 or PMS2 genes. More than one in 300 people have LS but most... Read more

Hematology

view channel
Image: The Gazelle Hb Variant Test for screening, diagnosis and management of sickle cell disease and related hemoglobinopathies at the point of care (Photo courtesy of Hemex Health)

Point-of-Care Device Accurately Rapidly Diagnoses Sickle Cell Disease

Hemoglobinopathies are the most common autosomal hereditary disorders. Approximately 7% of the global population carries hemoglobin gene mutation including structural hemoglobin variants like sickle hemoglobin... Read more

Immunology

view channel
Image: The IMMULITE 2000 XPi Immunoassay System provides multiple tests on a single, easy-to-use analyzer, including the thyroid-stimulating immunoglobulin assay (Photo courtesy of Siemens Healthcare)

Immunoassays Evaluated for Thyroid-Stimulating Receptor Antibody in Graves’ Disease

Graves' disease (GD), also known as toxic diffuse goiter, is an autoimmune disease that affects the thyroid. It frequently results in and is the most common cause of hyperthyroidism and it also often results... Read more

Pathology

view channel
Illustration

AI Accurately Detects and Diagnoses Colorectal Cancer from Tissue Scans As Well or Better Than Pathologists

Artificial intelligence (A) can accurately detect and diagnose colorectal cancer from tissue scans as well or better than pathologists, according to a new study. The study, which was conducted by researchers... Read more

Technology

view channel
Image: PKeye Workflow Monitor System (Photo courtesy of PerkinElmer, Inc.)

PerkinElmer’s New Cloud-Based Platform Enables Laboratory Personnel to Remotely Manage Its Instruments in Real-Time

PerkinElmer, Inc. (Waltham, MA; USA) has launched its PKeye Workflow Monitor, a cloud-based platform enabling laboratory personnel to remotely manage and monitor their PerkinElmer instruments and workflows... Read more

Industry

view channel
Illustration

Global Point of Care Diagnostics Market to Top USD 35 Billion by 2027 Due to Rising Diabetic Cases

The global point of care diagnostics market is projected to grow at a CAGR of close to 6% from more than USD 23 billion in 2020 to over USD 35 billion by 2027, driven by an increase in the number of diabetic... Read more
Copyright © 2000-2021 Globetech Media. All rights reserved.