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Under a proposed rule, devices given FDA's breakthrough designation would, upon receiving FDA market authorization, immediately be covered by Medicare.
The serum-based proteomic test gauges a pre-treatment immune profile that has shown in retrospective studies to identify patients who are likely to respond well to anti-PD-1 therapy.
The UK government said that the funding aims to support faster and more accurate cancer diagnosis and more personalized treatments for patients.
The goal of the project is to build a liquid biopsy-based early detection technology platform and develop tests for lung and digestive system cancers.
The test is a version of Thermo Fisher Scientific's TaqPath COVID-19 Combo Kit that has been modified for use with a different PCR instrument and plate format.
In clinical samples, the researchers detected more viral copies in saliva than in NP swabs, and more saliva samples remained positive for up to 10 days.
News items for the in vitro diagnostics industry for the week of August 24, 2020.
While the market ditched shares of many other diagnostics firms, analysts said the reaction was overblown, particularly in the case of Quidel and molecular diagnostics players.
Researchers analyzed the performance of a dozen SARS-CoV-2 serology assays on samples from COVID-19 patients, patients with other disease, and pre-pandemic samples.
Amoy will develop its AmoyDx Pan Lung Cancer PCR Panel (9-in-1 Plus) as a companion diagnostic test for Haihe's MET kinase inhibitor Glumetinib.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.
The trial will use Natera's Signatera test to determine patient enrollment eligibility based on the presence of ctDNA and to evaluate response based on ctDNA clearance.
KidneyIntelX is designed to help assess the risk of progressive decline in kidney function in patients with type 2 diabetes and chronic kidney disease.
The lateral flow test delivers results in 15 minutes without instrumentation and has a sensitivity of 97 percent and specificity of almost 99 percent.
QDx's RT-PCR-based test is designed to detect the SARS-CoV-2 N gene, while Biocan's immunoassay is designed to detect antibodies against the virus.
The PCR-based panel is designed to differentiate between SARS-CoV-2 and other common winter infections with high specificity and sensitivity.
Up to 35 private and public labs in France will be able to use UgenTec's FastFinder analysis software to scale up testing for SARS-CoV-2 and other pathogens.
The Signatera test is optimized for molecular residual disease (MRD) assessment and for monitoring treatment in cancer patients.
The company said proceeds will accelerate the ongoing FDA registrational study of its blood-based colorectal cancer screening test and further its extended pipeline.
The company said billable volume for its ConfirmMDx prostate cancer test fell 12 percent year over year, and volumes for its SelectMDx test fell 48 percent.
Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay is an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus.
Using MammaPrint to guide breast cancer chemo de-escalation could result in significant healthcare savings in five of six evaluated countries, according to the analysis.
The company said it is developing a rapid COVID-19 antibody test that will provide results in 12 minutes using a finger prick of blood.
Under the Emergency Use Authorizations, the RT-PCR tests may be performed by any laboratory CLIA-certified to perform high-complexity testing.
The society recommends routine use of multigene NGS for a handful of metastatic cancers, as well as in the context of clinical trials at academic centers.