FDA Clearance: Page 2

Zymo Research, Ad Astra Diagnostics receive FDA 510(k) clearances
By LabPulse.com staff writers
Molecular diagnostics firm Zymo Research and rapid diagnostics developer Ad Astra Diagnostics have both received 510(k) clearances from the U.S. Food and Drug Administration.
November 16, 2023
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FDA grants approval to Takeda’s metastatic colorectal cancer therapy
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved a chemotherapy-free oral target therapy for patients who have been previously treated for metastatic colorectal cancer (mCRC).
November 9, 2023
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3EO Health to launch FDA-approved COVID-19 test
By Matt Limb
Molecular diagnostics startup 3EO Health is preparing to launch a newly approved SARS-CoV-2 test with its portable molecular device, saying it will “expand access” to the technology.
October 20, 2023
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FDA authorizes Invitae hereditary cancer panel
By Nick Paul Taylor
The U.S. Food and Drug Administration (FDA) has granted de novo authorization to an Invitae panel that tests for hundreds of genetic variants that indicate whether a person has a higher risk of developing certain cancers.
October 5, 2023
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ProciseDx receives FDA de novo authorization for therapeutic drug monitoring tests
By LabPulse.com staff writers
ProciseDx has received U.S. Food and Drug Administrtion (FDA) de novo marketing authorization for its point-of-care tests for monitoring levels of infliximab and adalimumab in patients being treated for inflammatory bowel diseases.
October 5, 2023
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Thermo Fisher receives FDA clearance for neuroendocrine tumor assay
By LabPulse.com staff writers
Thermo Fisher has received clearance from the U.S. Food and Drug Administration (FDA) for its Brahms chromogranin A (CgA) II Kryptor test, a CgA immunoassay for assessing tumor progression in gastroenteropancreatic neuroendocrine tumor patients.
October 2, 2023
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FDA starts one-year pilot program to tackle risks of lab developed oncology tests
By Nick Paul Taylor
The goal is to provide laboratories with information to support development of LDTs for specific cancer biomarkers, to facilitate “better and more consistent” testing and, by extension, “better drug selection and improved care for patients with cancer."
July 21, 2023
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Roche receives FDA clearance for test to accelerate diagnosis of Alzheimer’s
By Nick Paul Taylor
The new 510(k) clearance covers two tests that run on Roche’s Elecsys immunoassay system. One of the assays, which measures beta-amyloid, was part of the 510(k) clearance that Roche received last year.
June 29, 2023
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FDA grants 510(k) clearance, CLIA waiver for BioFire multiplex respiratory panel
By LabPulse.com staff writers
The FDA reviewed the BioFire test through a dual 510(k) and CLIA waiver pathway, which was designed to speed bringing accurate IVD tests to CLIA-waived settings.
February 7, 2023
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FDA greenlights Precision BioLogic chromogenic assay to identify factor IX deficiency
By LabPulse.com staff writers
The assay is intended for use by clinical labs to identify factor IX deficiency in human plasma and aid in the management of hemophilia B.
January 5, 2023
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Roche nabs FDA clearance for two Alzheimer's disease CSF assays
By LabPulse.com staff writers
The assays measure beta Amyloid (1-42) and Phospho Tau (181P) concentrations in cerebrospinal fluid samples from adults age 55 and older.
December 8, 2022
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HemoSonics obtains FDA clearance for whole-blood hemostasis system, cartridge for POC use
By LabPulse.com staff writers
The system leverages medical-grade ultrasound technology to measure the coagulation properties of a whole blood sample.
November 30, 2022
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