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A bi-weekly listing of recent local coverage determinations from Medicare Administrative Contractors.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The company will donate full laboratory set-ups to the effort and provide training and education to implement screening programs.
ArcherDX said the firms aim to apply minimal residual disease monitoring in clinical-trial protocols and for future therapy optimization.
The warning letters may signal increased vigilance from the FDA against firms offering coronavirus antibody tests that it believes could harm consumers.
The suit comes shortly after Progenity filed for an initial public offering in which it is seeking to raise up to $122.6 million.
The novel blood test uses vibrational spectroscopy and metabolomic analysis to differentiate patients with fibromyalgia from those with other autoimmune disorders.
Applied BioCode's test may be performed by any CLIA-certified lab, while Kaiser Permanente's and Emory's must be run at their developers' labs.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
The FDA said that data from the company and an independent evaluation of the test found a higher than expected rate of false results.
In April the firm received notice that it wasn't in compliance because its common stock didn't maintain a minimum bid price of $1.00 for 30 consecutive business days.
The new funding opportunities come as part of the NIH's Rapid Acceleration of Diagnostics program, which aims to support SARS-CoV-2 testing technologies.
Todos said that it aims to develop an at-home 3C protease-based kit that uses a cell-phone camera and software for data analysis to test for the coronavirus.
The test will comprise a smartphone-powered single-use, disposable device that detects active SARS-CoV-2 infection based on the presence of viral proteins.
Yourgene will provide molecular COVID-19 testing to corporate clients of Caxton, who will obtain their results through Hooha Innovations' Prova app.
Roche will have non-exclusive access to SpeeDx's existing tests and technology to enable expansion of diagnostic products for antibiotic resistance in STIs.
The company recently agreed to pay millions to three major insurers under settlement agreements related to allegations over undisclosed past business practices.
The Beijing-based company offers genomics products and services, including PCR instruments and cancer sequencing, and maintains a research center in the US.
The test has 100 percent sensitivity and almost 100 percent specificity, and the company has ramped its manufacturing capacity to deliver 30 million tests per month.
The test has been developed to run on Illumina's NextSeq 550Dx next-generation sequencing platform and will be prepared for commercial launch in Europe.