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FDA Clearance: Page 3
BD secures BARDA funds for development of COVID-19 test
Under terms of the deal, BARDA will extend its support to BD by up to $40.3 million for the development and U.S. Food and Drug Administration (FDA) clearance of five new tests:
November 1, 2021
Thermo Fisher touts product launches at AACC 2021
For COVID-19, there are two polymerase chain reaction (PCR) tests: the Applied Biosystems TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the Applied Biosystems TaqPath COVID-19 RNase P Combo Kit 2.0. The tests target eight genes across three regions of SARS-CoV-2.
September 28, 2021
Techcyte secures $21M in funding
As part of this effort, the company will use the cash to complete necessary market clearance applications to the U.S. Food and Drug Administration (FDA), it said.
August 22, 2021
Promega's OncoMate MSI system cleared by FDA
With the FDA clearance, the company said oncologists and pathologists in the U.S. can now access the IVD test that screens for Lynch syndrome in patients with colorectal cancer.
July 29, 2021
NYU Langone genetic cancer test gets FDA 510(k) clearance
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
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
Quest launches long-COVID testing panels for consumers
Ohio, Kentucky doctors convicted in scheme to bill Medicaid for millions of dollars in unnecessary urinalysis testing
RNA-seq analysis links protein to spread of pancreatic cancer, reveals potential drug target
Patients prefer immediate test results, even when the news is bad
Point-of-care test developer Proxim Diagnostics obtains strategic investment from BioMérieux
Quest Diagnostics offers suite of services for transplant patients and living donors
FDA grants first coronavirus clearance for sample pooling to Quest
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
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
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
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
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
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
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