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Clinical Lab Management

News on issues related to managing clinical laboratories.

The agency has provided new guidance for tests that can be used outside of a lab setting, as well as updated its guidance on a number of other topics.

The FDA reissued the EUA after analyzing LabCorp data that showed the test could detect SARS-CoV-2 in a general asymptomatic population.

KidneyIntelX can be used to report risk assessment results for fast-progressing kidney disease and future kidney failure for patients with chronic kidney disease.

In January a federal court unsealed a False Claims Act suit from an industry insider that alleges a Myriad subsidiary engaged in a fraudulent kickback scheme.

The company said that by the end of June it would have made available more than 500,000 kits, which allow individuals to self-collect nasal samples at home.

The Washington Post writes that the approval in the US of a SARS-CoV-2 vaccine will be up to Peter Marks, a career official at the Food and Drug Administration.

According to ScienceInsider, the US National Academies of Science, Engineering, and Medicine is planning a study of racism in academic research.

NPR reports the US loan to Eastman Kodak to boost domestic pharmaceutical production is on pause following insider trading allegations.

In Cell this week: blood immune cell changes in COVID-19 patients and spatial transcriptomics in Alzheimer's disease.

Aug
18
Sponsored by
Bio-Rad

As worldwide COVID-19 cases continue to rise, there is a significant need to increase testing and population surveillance capacity.

Aug
19
Sponsored by
UgenTec

This webinar will present a case study from in vitro diagnostics developer SpeeDx on its experience building a complete sample-to-result workflow — encompassing instrumentation and data analysis software — for its qPCR-based ResistancePlus MG Mycoplasma genitalium assay.

Aug
25
Sponsored by
Roche

Non-small cell lung cancer (NSCLC) patients with ALK rearrangements are treated with tyrosine kinase inhibitors (TKIs), which often leads to prolonged overall survival. However, treatment resistance will almost inevitably occur, and the disease remains incurable.

Aug
26
Sponsored by
Bionano Genomics

Alzheimer’s disease is genetically complex with no meaningful therapies or pre-symptomatic disease diagnostics.