FDA Clearance: Page 5

NYU Langone genetic cancer test gets FDA 510(k) clearance

By LabPulse.com staff writers

Using next-generation sequencing, the test detects the DNA code changes of 607 genes linked by past studies to the development of multiple types of cancer, according to the institution. It matches the genetics of each patient's tumor cells with approved therapies targeted to specific sets of cancer-causing DNA changes, NYU Langone said.

July 28, 2021

Bruker launches microbe test kit following FDA clearance

By LabPulse.com staff writers

Rapid sepsityper identification is crucial for the care of critically ill patients in order to reduce turnaround time for disease-specific treatment, noted Dr. Wolfgang Pusch, executive vice president of microbiology and diagnostics at Bruker. The new test kit can identify microbial species once a blood culture system has detected growth, but it does not test for resistance of antibiotic susceptibility.

January 3, 2021

FDA grants first coronavirus clearance for sample pooling to Quest

By LabPulse.com staff writers

The Quest SARS-CoV-2 real-time reverse transcription polymerase chain reaction (RT-PCR) test was granted clearance on July 18 for use in testing specimens for up to four individuals. It was previously granted clearance for testing individual samples in March.

July 19, 2020

FDA finds false results with Chembio coronavirus antibody test, revokes clearance

By Emily Hayes

The agency announced the removal of the immunoglobulin M (IgM) and immunoglobulin G (IgG) test on June 16. In a statement, the agency noted that the test was one of the first to get an authorization and that initially the product met its standards during the COVID-19 public health emergency when it had appeared that benefits outweighed harms.

June 16, 2020

Cue gets FDA clearance for point-of-care coronavirus test

By LabPulse.com staff writers

The Cue Health COVID-19 molecular test detects SARS-CoV-2 nucleic acid from a nasal swab sample. It runs a 25-minute analysis directly at the point of care and delivers the results to the Cue mobile app.

June 14, 2020

FDA grants first clearance of sequencing-based COVID-19 test to Illumina

By LabPulse.com staff writers

COVIDSeq is a high-throughput, IVD test that detects SARS-CoV-2 from samples taken from nasopharyngeal or oropharyngeal swabs. The test runs on the NovaSeq 6000 sequencing system and delivers results within 24 hours, according to the company. Its design includes 98 amplicons that target the full SARS-CoV-2 genome, creating accurate detection and high sensitivity, Illumina said.

June 9, 2020

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

By LabPulse.com staff writers

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

AACC objects to FDA's at-home virus kit clearance, following go-ahead for Everlywell

By Emily Hayes

The FDA has been approving products related to SARS-CoV-2 rapidly through the EUA pathway. In a letter to FDA Commissioner Stephen Hahn, the AACC said that this haste has resulted in the "introduction of an unproven product into the market." The letter referenced a product that received clearance on May 16, without noting a product or company name.

May 20, 2020

New FDA clearances for companion cancer tests from Myriad, Foundation Medicine

By LabPulse.com staff writers

Lynparza, which is sold by Merck and AstraZeneca, is a poly (ADP-ribose) polymerase (PARP) inhibitor that was just approved by the FDA for a new indication in treating patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer who progressed after treatment with the drugs enzalutamide (Xtandi) or abiraterone (Zytiga). Per product labeling, patients should be selected with an FDA-approved companion test.

May 19, 2020

Abbott lands 5th EUA for COVID-19 tests

By LabPulse.com staff writers

The company is in the process of launching Alinity m, which received FDA clearance in March. The system can process up to 1,080 tests in 24 hours and can now utilize the COVID-19 molecular test under the EUA, the firm said.

May 11, 2020

FDA grants 1st clearance of at-home saliva test for coronavirus

By LabPulse.com staff writers

Rutgers Clinical Genomics Laboratory secured an amended emergency use authorization (EUA) from the FDA for the laboratory-developed test. In April, the university lab had received an EUA for the saliva test, but the clearance stipulated that the collection of saliva specimens should be performed in a healthcare setting under the supervision of a trained healthcare provider.

May 7, 2020

PGDx secures FDA clearance for tumor genomic profiling kit

By LabPulse.com staff writers

With the FDA clearance, molecular laboratories can now use the next-generation sequencing diagnostic kit to perform broad tumor profiling, according to the vendor. The test detects complete single nucleotide variants (SNVs) and small insertions and deletions (indels) in more than 500 genes, select amplifications and translocations, and genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB), PGDx said. Data analysis is automated.

April 27, 2020

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