FDA clears Akonni's test for warfarin genotyping

LabPulse.com staff writers
Jun 6, 2019
2019 05 10 17 42 3167 Lab Doctors Dna 400

Akonni Biosystems is set to introduce a new noninvasive saliva test designed to help doctors decide which patients to send on for blood thinner therapy with warfarin after the product was cleared by the U.S. Food and Drug Administration (FDA).

Akonni's TruDiagnosis system is designed to detect genetic deficiencies in the cytochrome P450 enzyme CYP2C9, which is important for metabolizing warfarin. The company announced the clearance of TruDiagnosis on June 6.

TruDiagnosis includes the TruDx 2000 imager and TruArray consumable test kit and received 510(k) clearance on May 24 for DNA genotyping of clinical samples. In its statement about the clearance, Akonni said it wants to work with partners to build their own diagnostic assays -- laboratory-developed tests and research-use-only units -- with its TruArray consumable device. The company is also working to expand its own menu of assays that may be used with the system.

Latest in 510(k)
Digital Pathology Cytology Social
Leica Biosystems granted FDA clearance for Class II mismatch repair panel
April 3, 2023
Fda Button Social
FDA grants 510(k) clearance to DiaSorin for COVID-19 and flu A/B assay
March 20, 2023
Visit our Molecular Diagnostics Community
Sponsored
Visit our Molecular Diagnostics Community
May 11, 2023
Football Player Concussion Social
FDA grants clearance to Abbott for first commercial laboratory test to detect traumatic brain injury
March 7, 2023
Related Stories
2020 05 06 19 00 3862 Pharmacogenetics Theme 400
Accreditation
Pathology guideline standardizes warfarin genotype testing
2019 06 13 22 59 4303 B Vitamin Pills 400
Guideline
FDA sets standards for biotin lab tests
2019 05 11 00 50 2324 Check Mark Stars 400
Pathology, histology
AMP, CAP show labs what they need to include in CYP2C9 tests
Visit our Molecular Diagnostics Community
Sponsor Content
Visit our Molecular Diagnostics Community
More in 510(k)
Leica Biosystems granted FDA clearance for Class II mismatch repair panel
The Bond MMR Antibody Panel is available for clinical use on its automated Bond-III and Bond-Max immunohistochemistry instruments.
April 3, 2023
Digital Pathology Cytology Social
FDA grants 510(k) clearance to DiaSorin for COVID-19 and flu A/B assay
The test detects and differentiates influenza A, influenza B, and SARS-CoV-2 viruses to help ensure physicians can recommend the most appropriate treatment for each patient.
March 20, 2023
Fda Button Social
Becton Dickinson nabs FDA clearance for infectious vaginitis molecular test
The BD vaginal panel running on the high-throughput BD Cor molecular diagnostic system tests for multiple common types of vaginitis using only a swab and one test.
March 16, 2023
Bd Vaginal Panel Cor System
FDA grants clearance to Abbott for first commercial laboratory test to detect traumatic brain injury
The test runs on Abbott's Alinity i laboratory immunoassay instrument, providing a result in 18 minutes to help clinicians quickly assess concussion and triage patients, Abbott said. Negative results rule out the need for a CT scan.
March 7, 2023
Football Player Concussion Social
Copan Diagnostics receives second FDA clearance for semiautomated preanalytical processor
With this second clearance, Colibri can prepare microbial suspensions for antibiotic susceptibility testing with the BioMérieux Vitek 2 system.
October 11, 2022
Lab Virus Bacteria Research
OIG: FDA recommendations for future pandemics
OIG offered numerous recommendations to manage such infectious disease emergencies, saying the FDA should access and, when appropriate, revise its guidance for Emergency Use Authorization (EUA) submissions for tests.
September 21, 2022
2021 11 29 23 50 3003 Fda Button 20211129235739
Week in Review: Multicancer early detection at ESMO, DiaSorin nabs FDA clearance for COVID-19 kit, IVD industry urges Congress to enact SALSA, and more
Dear LabPulse.com member,
September 14, 2022
FDA grants 510(k) clearance to DiaSorin for COVID-19 kit
The kit, which runs on DiaSorin's Liaison MDX molecular diagnostics system, provides a sample-to-answer test for the detection of SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens.
September 13, 2022
2021 08 23 18 25 2180 Covid Treatment Doctor 400
PixCell Medical, Insight Medical to distribute hematology analyzer
PixCell said that its HemoScreen hematology analyzer delivers lab-grade diagnostics at the point of care without the need for external reagents or extensive training.
September 5, 2022
2021 01 12 23 44 3780 Blood Test Samples Lab 400
Cue Health requests FDA de novo clearance for at-home flu test
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
2022 09 02 19 52 9683 Flu Season Ahead 400
NanoDx, SkyWater launch nano biosensor
The companies said that as a result of the development, NanoDx is ready to prepare and submit the product for review by the U.S. Food and Drug Administration (FDA) with the aim of eventually commercializing a product based on the technology.
August 25, 2022
2021 06 30 22 19 4138 Digital Science Lab 400
FDA issues updated reagent, instrument guidance
The agency said that it revised the current guidance to include point-of-care in vitro diagnostic (IVD) devices in certain situations, flowcharts, updates to examples, and further clarification of terminology.
August 15, 2022
2021 11 29 23 50 3003 Fda Button 20211129235739
Page 1 of 16
Next Page