Promega's OncoMate MSI system cleared by FDA

LabPulse.com staff writers
Jul 29, 2021
2019 05 22 19 44 5254 Dna Red Laser 400

Promega announced that its OncoMate microsatellite instability (MSI) Dx Analysis System has been cleared by the U.S. Food and Drug Administration (FDA) for use in labs in the U.S.

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.

Latest in FDA Clearance
Fda Button Social
FDA grants 510(k) clearance, CLIA waiver for BioFire multiplex respiratory panel
February 7, 2023
Fda Sign Dc Social
FDA greenlights Precision BioLogic chromogenic assay to identify factor IX deficiency
January 5, 2023
Alzheimers Phases Amyloid Social
Roche nabs FDA clearance for two Alzheimer's disease CSF assays
December 8, 2022
Lab Blood Samples Social (1)
HemoSonics obtains FDA clearance for whole-blood hemostasis system, cartridge for POC use
November 30, 2022
Related Stories
2020 04 14 22 00 7772 Business Men Handshake 400
Sarcoma
Stilla and Promega sign comarketing agreement
2019 09 16 18 27 8672 Quality Check Mark 400
COVID-19
Promega SARS-CoV-2 antibody test gets CE Mark
2020 07 20 15 52 6356 Epidemiologist Lab 400
CE mark
Promega to further develop OncoMate MSI assay
2020 07 20 15 52 6356 Epidemiologist Lab 400
PCR
Promega seeks EUA for COVID-19 antibody detection test
More in FDA Clearance
FDA grants 510(k) clearance, CLIA waiver for BioFire multiplex respiratory panel
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
Fda Button Social
FDA greenlights Precision BioLogic chromogenic assay to identify factor IX deficiency
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
Fda Sign Dc Social
Roche nabs FDA clearance for two Alzheimer's disease CSF assays
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
Alzheimers Phases Amyloid Social
HemoSonics obtains FDA clearance for whole-blood hemostasis system, cartridge for POC use
The system leverages medical-grade ultrasound technology to measure the coagulation properties of a whole blood sample.
November 30, 2022
Lab Blood Samples Social (1)
Empatica receives FDA clearance for digital biomarker platform, closes Series B financing
The platform is used to gather and analyze physiological data for clinical trials evaluating new therapeutics. Empatica is collaborating with researchers on digital biomarkers for use as endpoints.
November 23, 2022
Computer Woman Ai Social
DiaSorin congenital CMV direct assay receives FDA 510(k) clearance
The molecular diagnostic test enables direct detection of cytomegalovirus (CMV) DNA in saliva swab and urine specimens from babies 21 days old or younger.
November 9, 2022
Baby Bottle Social
Most Popular
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
LumiraDx Q4 revenues drop 65% on lower COVID-19 testing
Patients prefer immediate test results, even when the news is bad
Point-of-care test developer Proxim Diagnostics obtains strategic investment from BioMérieux
More in FDA Clearance
FDA clears Baebies disposable G6PD test
The rapid point-of-care test uses a drop of blood to detect glucose-6-phosphate dehydrogenase (G6PD) deficiency, which causes hemolytic anemia.
November 9, 2022
Hospital Baby Nurse Social
Abbott nabs first FDA EUA for a commercial test kit to detect monkeypox
Abbott Molecular received an EUA for an RT-PCR test intended to detect monkeypox DNA using lesion swab specimens from individuals suspected of monkeypox virus infection.
October 7, 2022
Infectious Diseases Research Social
Boston Cell Standards nabs FDA clearance for IHC test panel to evaluate breast cancers
Boston Cell Standards on Thursday announced that the FDA has granted 510(k) clearance for the company’s IHControls panel for evaluating breast cancers.
October 6, 2022
Breast Cancer
Roche nabs FDA clearance for low- to mid-volume lab system
A member of the Cobas family of serum-work-area solutions, the system combines clinical chemistry, immunoassay, and ion-selective electrode diagnostic testing onto a single platform to optimize space and resources for low- to mid-volume labs. It automates manual tasks, improves productivity, and supports fast delivery of patient results, Roche said.
September 18, 2022
2022 09 19 20 10 3970 20191120 Roche Pure Links 5 Us 400
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
Tasso nabs FDA clearance for blood collection lancet
The company will now be able to sell the device to more pharmaceutical companies, healthcare organizations, and academic institutions across the U.S.
September 13, 2022
2022 06 09 18 00 5852 Lab Blood Samples 400
Page 1 of 5
Next Page