Research & Development
Pathology & AI
PCR: Page 2
PerkinElmer nabs first FDA authorization for assay to screen for spinal muscular atrophy in newborns
The assay may be used by certified laboratories for the simultaneous detection of spinal muscular atrophy and severe combined immunodeficiency in newborns.
November 14, 2022
AMP update: Roche obtains regulatory approvals for six assays on compact MDx system
The approvals are part of an overall plan to make the broad menu of tests already running on its high-throughput Cobas 6800/8800 MDx systems also available on the more compact Cobas 5800.
November 7, 2022
Roche to launch compact MDx instrument at AMP meeting, obtains FDA premarket approval for HIV assay
Both the assay and system will be available in U.S. markets in Q4. Roche will showcase both this week at the Association for Molecular Pathology (AMP) 2022 Annual Meeting.
November 1, 2022
Thermo Fisher Scientific unveils digital PCR wastewater surveillance kit for SARS-CoV-2
The kit provides absolute quantification of relevant SARS-CoV-2 targets from wastewater samples and makes results available within two hours.
October 31, 2022
Biocartis to present 9 abstracts on MDx platform, assays at AMP 2022
One study evaluates the performance of the Immunexpress SeptiCyte Rapid ethylenediamine tetraacetic acid blood-compatible cartridges on the Idylla platform.
October 31, 2022
University of Illinois spinout Shield T3 launches saliva-based PCR test for COVID, flu, RSV
Shield T3, a spinout of the University of Illinois, will offer a triple-virus PCR test kit, in anticipation of increased cases of COVID-19, flu, and RSV this winter.
October 25, 2022
Genetic causes identified for three rare diseases
Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease
SARS-CoV-2 infection weakens immune-cell response to vaccination, study suggests
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
Chembio CEO urges stockholders to tender remaining shares as deadline is extended for acquisition
Cue Health Q4 revenues decline 24% as firm expands, diversifies POC test menu
Roche Diagnostics SARS-CoV-2 Qualitative PCR test receives 510(k) clearance
Roche Diagnostics announced that its SARS-CoV-2 Qualitative PCR test has received FDA clearance for use on the company’s cobas 6800 and 8800 systems.
October 24, 2022
UCLA research shows rapid antigen tests may be effective tools for return-to-work programs
Researchers from UCLA conducted a study examining how antigen test results may be used to guide healthcare systems implementing return-to-work protocols.
October 24, 2022
Takara Bio, BioExcel Dx partner to develop and validate wide-coverage infectious disease panels
The testing method employs RT-PCR automation technology and reagents from Takara Bio to detect viruses, bacteria, fungi, and antimicrobial resistance genes specific to the contributing pathogen.
October 17, 2022
US BioTek Laboratories providing monkeypox diagnostic testing
The test provides results within 24 hours of receiving specimens and offers easy-to-read positive and negative report formats, US BioTek said.
October 14, 2022
Pandemic Response Lab releases three-target LDTs to detect monkeypox
The company said the tests detect three different viral genome targets: non-variola orthopoxvirus, monkeypox virus species, and monkeypox virus clade II.
October 13, 2022
SARS-CoV-2 molecular tests highly accurate in Canadian study
The diagnostic sensitivity of these molecular tests suggests that one negative test result can effectively rule out SARS-CoV-2 infection for most patients, the researchers said.
October 12, 2022
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