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More articles about Regulatory News & FDA Approvals

Though Guardant and Foundation have pioneered a path through the FDA for liquid biopsy tests, label differences highlight complex choices for oncologists.

The saliva collection devices are designed for use with third-party SARS-CoV-2 tests or home/self-collection kits and are not intended for sale to patients.

The point-of-care test runs on the VitaPCR instrument and delivers results in 20 minutes, and has been implemented at Charles De Gaulle airport.

Roche's real-time PCR test detects defined mutations of the epidermal growth factor receptor gene in DNA from non-small cell lung cancer patients.

The company's RT-PCR/MALDI-TOF test comprises five assays designed to detect the N, ORF1, and ORF1ab regions of the SARS-CoV-2 genome.

The reissued EUA expands the types of samples that may be used with the Broad Institute's PCR-based SARS-CoV-2 test, which was first authorized in July.

FoundationOne Liquid CDx can now be used as a companion diagnostic for therapies to treat advanced ovarian, breast, and non-small cell lung cancer.

The test analyzes substitutions, insertion and deletion alterations, and copy number alterations in 324 genes, along with some genomic signatures in solid tumors.

The reissued Emergency Use Authorization from the US Food and Drug Administration also permits the test's use in asymptomatic individuals, the firm said.

Wren Laboratories and P23 Labs received revised EUAs that allow their previously authorized tests to now be used with new specimen types.

The assay does not require nucleic acid extraction or purification, unlike a LumiraDx SARS-CoV-2 test that received Emergency Use Authorization in August.

DNA Genotek's devices are used with SARS-CoV-2 tests from Clinical Reference Laboratory and P23 Labs, while Clinical Enterprises' kit is offered by Eurofins.

The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.

Spectrum Solutions' specimen collection device is used with SARS-CoV-2 saliva tests from DxTerity Diagnostics and RUCDR Infinite Biologics.

Seasun Biomaterials' test is designed to detect SARS-CoV-2 RNA, while Zeus Scientific's test detects IgG antibodies against the virus.

The agency provided the update on Wednesday in its weekly virtual town hall and on its FAQ page.

The NGS-based test is intended for use by lab personnel trained to use Illumina's MiSeq and NextSeq systems.

BioFire's test is designed to detect and differentiate between SARS-CoV-2 and other respiratory pathogens, while UMass Medical's test is only for SARS-CoV-2.

The method uses heat for extraction, which the company said will improve test turnaround time and reduce reliance on nucleic acid extraction reagents.

Tempus' test is a modified version of Thermo Fisher Scientific's Applied Biosystems TaqPath COVID-19 Combo Kit, which previously received EUA from the FDA.

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Nature News writes that additional details about the UK plan for an agency to support high-risk, high-reward science are needed.

The New York Times reports that the US Food and Drug Administration has authorized Johnson & Johnson's SARS-CoV-2 vaccine.

The Wall Street Journal writes new studies are giving glimpses into the origins of SARS-CoV-2.

In PLOS this week: analysis of Plasmodium population structure, qPCR assay to diagnose scabies, and more.