FDA Clearance: Page 6

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
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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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LabCorp wins FDA clearance for at-home COVID-19 test
By LabPulse.com staff writers
The test kit can now be used by individuals to self-collect nasal swab specimens at home if recommended by a healthcare provider after completion of a COVID-19 questionnaire, according to LabCorp. Offered through the company's Pixel by LabCorp platform, the kits will initially be available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic.
April 20, 2020
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2 new antibody tests get FDA clearance
By LabPulse.com staff writers
The authorizations were issued to Ortho Clinical Diagnostics for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 total reagent pack and Chembio Diagnostic Systems for its DPP COVID-19 IgM/IgG system.
April 16, 2020
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DiaCarta test for novel coronavirus gets FDA clearance
By LabPulse.com staff writers
The QuantiVirus test evaluates nasopharyngeal swabs, oropharyngeal swabs, and sputum samples for three different RNA-encoded genes of SARS-CoV-2: N, Orflab, and E.
April 8, 2020
2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400
Siemens wins FDA clearance for blood gas analyzer
By LabPulse.com staff writers
Designed for diagnosis and monitoring of critically ill patients in the intensive care unit, operating room, or emergency room, RapidPoint 500e produces blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, according to the vendor. It previously received the European CE Mark and has already been utilized in European countries to support COVID-19 response efforts; blood gas testing is often required for ventilator-assisted patients and those being evaluated for respiratory distress, Siemens said.
March 30, 2020
2020 01 15 23 19 8499 Siemens Rsna 2019 400
Lexent Bio partners on NGS with Illumina
By LabPulse.com staff writers
Confera Dx is designed to monitor treatment response and the level of minimal residual disease (MRD) in cancer patients. The company plans to launch the product as a laboratory-developed test (LDT) with testing done at its own CLIA lab, and Lexent will also pursue clearance by the U.S. Food and Drug Administration (FDA) to enable use in the local labs of hospitals and health systems.
November 7, 2019
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Vela wins FDA clearance for HIV-1 genotyping NGS assay
By LabPulse.com staff writers
The FDA said the approval is its first for an HIV drug resistance assay using NGS technology. The Sentosa SQ HIV-1 genotyping assay is meant for use only in patients with HIV-1 who are about to start or are already taking antiviral therapy, according to the FDA. It's not intended for diagnosing infection with HIV. The test results are intended to be used in conjunction with clinical observations, patient history, and other laboratory evidence to make patient management decisions, the FDA noted.
November 5, 2019
2019 02 13 19 24 5396 Fda Logo V2 400
Sekisui announces Acucy flu test clearance
By LabPulse.com staff writers
The test is designed for use with the company's Acucy point-of-care reader, which Sekisui said can be used to test nasal and nasopharyngeal swabs onsite as well as in laboratory settings. Sekisui announced the clearance on October 8, following an FDA decision on December 17, 2018.
October 8, 2019
2019 10 09 20 17 0927 Influenza Virus 400
Beckman Coulter launches DxA 5000 for lab automation in U.S.
By LabPulse.com staff writers
The company announced the FDA clearance and the system's availability in the U.S. on October 9, following a decision by the FDA on October 4. Beckman Coulter had showcased the DxA 5000 system, along with other workflow solutions for improving throughput in labs, at the American Association for Clinical Chemistry annual meeting in August and announced its approvals in Europe and China in May.
October 8, 2019
2019 08 20 21 56 4830 Beckman Coulter Aacc 2019 400
Applied BioCode files 510(k) for respiratory panel
By LabPulse.com staff writers
The BioCode RPP works with the company's MDx-3000 molecular system. It tests swabs from the back of the nose and throat for 20 common viruses and bacteria, including influenza A, influenza B, respiratory syncytial virus (RSV), and Chlamydia pneumoniae. Up to 188 samples may be processed during an eight-hour shift, according to the company.
September 12, 2019
2019 09 13 20 38 3693 Respiratory Syncytial Virus Cdc 400
Binx point-of-care STI testing clears FDA
By LabPulse.com staff writers
The polymerase chain reaction (PCR) product includes a benchtop instrument with a single-use, assay-specific cartridge. Vaginal swabs may be collected by patients in a clinical setting or by laboratorians, and results are available within half an hour, according to the company.
August 11, 2019
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