Kerri Fitzgerald

DocwireNews

The U.S. Food and Drug Administration granted breakthrough-therapy designation&nbsp;to&nbsp;PapGene&nbsp;liquid biopsy test for the detection of cancer among people&nbsp;&gt;65 years&nbsp;old.&nbsp;PapGene&nbsp;is a multianalyte test that&nbsp;uses circulating tumor DNA and protein biomarkers to detect cancer&nbsp;in average risk, asymptomatic individuals.&nbsp;The decision was based on&nbsp;test&rsquo;s ability to detect both ovarian and pancreatic cancer.&nbsp;In a retrospective study published in&nbsp;Science, a similar assay reliably detected eight types of cancer with a median of sensitivity of 70%.&nbsp;<blockquote class="twitter-tweet" data-width="500" data-dnt="true">
<a href="https://t.co/lvnkbmkooa">https://t.co/lvnkbmkooa</a> PapGene, Inc. Receives FDA Breakthrough Device Designation for Liquid Biopsy Test that Detects Multiple Cancers&hellip;
&mdash; OBR Oncology (@OBRtweets) <a href="https://twitter.com/OBRtweets/status/1027521362670379008?ref_src=twsrc%5Etfw">August 9, 2018</a>
</blockquote><script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script>PapGene&nbsp;is currently developing a clinical version of their liquid biopsy test that could detect cancer earlier than current standard-of-care methods.&nbsp;<a href="https://proddocwire.wpengine.com/docwire-pick/a-simple-blood-test-for-melanoma-detection/">Read about a simple blood test for melanoma detection.</a>&nbsp;<a href="https://proddocwire.wpengine.com/hematology-oncology/individual-testing-effective-but-timely-and-costly-in-screening-for-zika-virus-in-blood-donations/">Screening blood for Zika is timely, yet costly.</a>&nbsp;Source:&nbsp;<a href="https://papgeneinc.com/2018/08/08/fda-breakthrough-device/">PapGene, Inc.&nbsp;</a>

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FDA Grants Breakthrough Designation for Liquid Biopsy Test to Detect Cancers

Oncology

The U.S. Food and Drug Administration granted breakthrough-therapy designation to PapGene liquid biopsy test for the detection of cancer among people &gt;65 ...

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