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FDA Clearance: Page 4
New FDA clearances for companion cancer tests from Myriad, Foundation Medicine
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
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
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
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
LabCorp wins FDA clearance for at-home COVID-19 test
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
2 new antibody tests get FDA clearance
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
DiaCarta test for novel coronavirus gets FDA clearance
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
Siemens wins FDA clearance for blood gas analyzer
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
Lexent Bio partners on NGS with Illumina
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
Vela wins FDA clearance for HIV-1 genotyping NGS assay
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
Sekisui announces Acucy flu test clearance
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
Beckman Coulter launches DxA 5000 for lab automation in U.S.
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
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