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The company released data showing that its panel detects early-stage liver cancer with 71 percent sensitivity compared to 25 percent for the standard test.

Despite the step-up in FDA action against labs offering PGx tests, the success of these programs suggests that access to them isn't being stifled as some feared.

In a survey conducted by an association working group, 40 percent of respondents said they are already offering TMB, with most others planning to do the same within the year.

Due out in December, the Magnis automated library prep instrument is meant to be an affordable and easy way for researchers to use Agilent's SureSelect kits.

Newly appointed interim CEO Thierry Bernard attempted to assuage investors' fears in the wake of a tumultuous month for Qiagen.

In a study published this week, researchers presented a Simoa-based assay for tuberculosis that could ultimately be packaged as a point-of-care test.

The assay, being developed in partnership with Johnson & Johnson, will complement computed tomography imaging by combining 26 genes and clinical variables for lung cancer detection.

The company launched a "core" service using Illumina microarray genotyping, and has plans for an expanded NGS offering with Quest Diagnostics.

While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.

The firm hopes to return fewer VUS in its test reports and to accelerate the resolution of uncertain results issued to patients in that past.

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