Respiratory Infection: Page 2

GenMark releases new rapid respiratory infection panel test

The company's ePlex Respiratory Pathogen 2 (RP2) panel is now available in the U.S. for distribution and use. Earlier this month, GenMark requested an emergency use authorization for the panel with the U.S. Food and Drug Administration.

June 28, 2020

Diagnostics wanted for emerging infections, tomorrow's pandemics

In a 2018 global IVD market report, Kalorama Information lead analyst Shara Rosen wrote that the dark side of globalism is the spread of unwanted conditions. There are many examples of previously unknown or rare pathogens that spread and became a major problem globally -- this can happen rapidly with people traveling by air throughout the world, Rosen noted.

June 18, 2020

Quidel builds point-of-care respiratory infection panel with BARDA cash

The funding will support the development of a point-of-care diagnostic assay that tests for SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus. The respiratory virus panel would run on Quidel's Sofia 2 flagship instrument.

June 11, 2020

Sekisui secures FDA clearance, CLIA waiver for rapid flu antigen test

Utilizing traditional lateral flow technology, the test kit is designed for qualitative detection of influenza type A and type B nucleoprotein antigens from nasal or nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. The company noted the importance of being able to rule flu in or out in the process of assessing patients for other respiratory infections during the COVID-19 pandemic.

June 8, 2020

ThermoGenesis gets FDA nod for COVID-19 antibody kit

The FDA letter means that ThermoGenesis can begin distributing the diagnostic kit, which detects the immunoglobulin M/immunoglobulin G (IgM/IgG) antibodies that result from infection with SARS-CoV-2, the virus that causes the COVID-19 respiratory disease.

April 15, 2020

Siemens debuts test kit for COVID-19

Siemens optimized the FTD SARS-CoV-2 assay test kits for the BioMérieux EasyMag extraction system and Applied Biosystems 7500 real-time polymerase chain reaction (PCR) thermocycler. The new kits mirror the workflow of other FTD kits from the company and can be used with FTD Respiratory Pathogens 21, the company's molecular testing panel for acute respiratory infections.

April 2, 2020

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Quest Diagnostics Q4 revenues down 15% on COVID testing but base business grew

In pilot study, liquid biopsy test differentiates between localized and metastatic cancer to inform tailored treatment

SD Biosensor, SJL Partners complete acquisition of Meridian Bioscience

Roche reports flat diagnostics revenue growth for 2022

French point-of-care testing firm Biosynex to acquire Chembio Diagnostics for $17.2M

OIG report outlines challenges with CDC-supported COVID-19 vaccination programs

Qiagen taps CEO, ships coronavirus tests to U.S.

Bernard was named interim CEO after the departure of Peer Schatz in October. Bernard had previously been the head of Qiagen's molecular diagnostics business.

March 23, 2020

As COVID-19 crisis continues, other infectious diseases threaten

As of March 16, the World Health Organization (WHO) had reported more than 137,000 confirmed cases and over 6,600 deaths worldwide from COVID-19, the respiratory disease caused by the SARS-CoV-2 virus. The diagnostics industry is rising to the challenge presented by the coronavirus pandemic, with test developers creating new assays to detect SARS-CoV-2 infection as lab operators ramp up throughput to meet skyrocketing demand.

March 17, 2020

CMS adds new code for coronavirus tests

The code (U0002) can be used by laboratories to bill for tests for SARS-CoV-2 infection and the respiratory disease caused by the virus, COVID-19, using diagnostics that are not provided by the U.S. Centers for Disease Control and Prevention (CDC). CMS issued the first code, U0001, to track patients tested with the CDC's own diagnostic for the coronavirus.

March 5, 2020

Lumos gets cash to expand reach of respiratory test

Lumos is a Planet Innovation spin-off that merged with RPS Diagnostics in May 2019. The company plans to use the funding to support international market expansion of its FebriDx point-of-care (POC) respiratory infection test, as well as a pivotal trial to support approval of the product by the U.S. Food and Drug Administration (FDA).

February 5, 2020

Fusion Genomics secures $1M U.S. to study respiratory infections panel

The Consortium Québécois sur la Découverte du Medicament (CQDM) is a Montreal-based biomedical research consortium that funds new technologies with potential value in facilitating drug discovery and development. The organization noted that since it was founded in 2008, it has raised more than $118 million Canadian ($90 million U.S.) through Canadian government programs and a wide range of pharmaceutical industry partners, including Merck, Pfizer, AstraZeneca, and Eli Lilly.

January 9, 2020

Curetis plans Q1 U.S. launch for Unyvero pneumonia test

Designed for use with the company's Unyvero system, the LRT bronchoalveolar panel screens for pneumonia and other respiratory infections. It detects a broad range of causes of infections, including atypical pathogens, such as the fungus Pneumocystitis jirovecii, and screens for antibiotic resistance markers, which is helpful for guiding treatment decisions, according to the company.

December 22, 2019

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