FDA clears acute infection and sepsis test

Inflammatix recently announced Food and Drug Administration marketing authorization for its TriVerity Test System for patients with suspected acute infection or sepsis.

Using precise measurements of a patient’s immune response, TriVerity combines highly accurate bacterial-viral infection scoring with an all-cause illness severity risk evaluation, giving clinicians a rapid, holistic snapshot of a patient’s status.

TriVerity measures the expression levels of 29 genes associated with the host immune response to infection. Using validated algorithms with artificial intelligence and machine learning, the test interprets host response information to give three scores for likelihood of bacterial infection, viral infection, and severe illness.

Because TriVerity provides a precise measure of infection likelihood and risk stratification, the test can help ease emergency department overcrowding and reduce length of stay for admitted patients, the company said.

In 2019, Inflammatix won the Association for Diagnostics & Laboratory Medicine’s (formerly AACC’s) Disruptive Technology Award for its rapid HostDx tests, which read the immune system to improve diagnosis of acute infections and sepsis.

FDA clears molecular point-of-care STI tests

Roche has announced Food and Drug Administration 510(k) clearance and a CLIA waiver for its cobas liat sexually transmitted infection (STI)
multiplex assay panels.

The panels include PCR tests for chlamydia, gonorrhea, and Mycoplasma genitalium and provide results in 20 minutes. The tests have the potential to broaden access to accurate, easy-to-use diagnostics for patients in urgent care centers, retail clinics, and community health venues, Roche said.

Rapid molecular point-of-care testing could revolutionize clinical management of STIs — which are frequently asymptomatic — in decentralized and community-based healthcare settings, Roche officials added. The tests could enable more informed treatment strategies, better health outcomes for patients, and contain further spread by providing timely diagnosis.

Qiagen Mini Gastrointestinal Panel gets FDA clearance

Qiagen recently announced Food and Drug Administration clearance of its QIAstat-Dx Gastrointestinal Panel 2 Mini B.

The panel focuses on bacterial infections covering Campylobacter, Salmonella, Shiga-like toxin-producing Escherichia coli (STEC), Shigella, and Yersinia enterocolitica, all leading causes of gastrointestinal illness. The panel is designed to complement the QIAstat-Dx Gastrointestinal Panel 2 Mini B&V (Bacterial & Viral), which covers Campylobacter, Salmonella, STEC, Shigella, and Norovirus.

QIAstat-Dx Gastrointestinal Panel 2 Mini B runs on Qiagen’s QIAstat-Dx system and leverages its ability to quickly multiply many genetic targets using real-time PCR technology in the same reaction, delivering results in about 1 hour and with less than 1 minute of hands-on time. Cycle threshold values and amplification curves provide laboratories with additional information in the context of co-infections and are instantly viewable on the instrument touchscreen, with no additional software required.

SARS-CoV-2 assay gets FDA clearance

The Food and Drug Administration granted 510(k) clearance to Hologic’s Aptima SARS-CoV-2 assay.

The in vitro diagnostic test detects SARS-CoV-2 RNA from nasopharyngeal or nasal swab samples of people exhibiting signs and symptoms of a respiratory tract infection. Healthcare practitioners must perform the swabs.

The test uses Hologic’s transcription-mediated amplification chemistry, which can detect and quantify genetic sequences to determine the presence of respiratory viral pathogens.

Samples are processed in Hologic’s Panther system, which is used in labs across the United States and around the world, according to the company. Each Panther can provide initial results in less than 3 hours and process more than 1,000 tests in a 24-hour period. An additional Panther Fusion module can expand respiratory testing offerings.

FDA clears bioMérieux tests for GI pathogens and microorganism identification and antibiotic susceptibility

bioMérieux recently announced Food and Drug Administration 510(k) clearance for gastrointestinal and antibiotic susceptibility tests.

The Biofire Filmarray Gastrointestinal (GI) Panel Mid, a molecular panel, tests for 11 common bacteria, viruses, and parasites associated with gastroenteritis from one sample, with results available in approximately 1 hour. Designed for use on bioMérieux’s Biofire Filmarray 2.0 and Torch PCR platforms, this panel requires about 2 minutes of hands-on time for setup, with an approximate run time of 1 hour.

Vitek Compact Pro is a system for microorganism identification and antibiotic susceptibility testing that will help clinical laboratories diagnose infectious diseases and combat antimicrobial resistance. The system will help industrial laboratories identify contaminants.

With an ergonomic design and a simplified workflow, Vitek is designed to improve overall efficiency by enabling laboratory technicians to spend less time on sample loading and processing. Ideally suited for small and medium-sized laboratories, it helps laboratories transition from manual workflows to automated ones, bioMérieux said.

Point-of-care respiratory test cleared with CLIA waver

Visby Medical recently announced Food and Drug Administration (FDA) 510(k) clearance and a CLIA waiver for its Visby Medical Respiratory Health Test, a point-of-care assay that detects and differentiates between upper respiratory infections caused by influenza A and B and SARS-CoV-2.

The assay is the first rapid PCR, multiplexed, handheld test to receive these FDA designations after being granted Emergency Use Authorization in December 2022. The test fits in the palm of the hand and provides accurate results in under 30 minutes, according to Visby.

The test also enables clinicians to accurately diagnose and treat patients in remote care facilities and other resource-limited healthcare settings where centralized laboratory services are less accessible. Quicker diagnosis of patients with respiratory symptoms will help selection of the most appropriate treatments, the company said.

Pancreatic cancer test gets New York approval

Clinicians in New York can now order a highly sensitive blood test designed to detect pancreatic cancer far earlier than conventional approaches.

ClearNote Health recently announced that the New York State Department of Health Clinical Laboratory Evaluation Program approved its Avantect Pancreatic Cancer Test.

The Avantect Pancreatic Cancer Test is for patients at high risk of pancreatic cancer, including those newly diagnosed with type 2 diabetes who are at least 50 years old, as well as those with a family history or a genetic predisposition.

The test was designed to detect pancreatic cancer in its earliest stages by profiling the epigenomic biomarker 5-hydroxymethylcytosine in cell-free DNA and combining that data with other genomic information. Unlike conventional methods, ClearNote’s approach leverages the latest advances in machine learning and bioinformatics to provide a deeper understanding of the underpinnings of cancer development with unprecedented clarity, and to inform the next steps in a patient care pathway, ClearNote said.