Pharmaceutical Executive August 5, 2024
Mike Hollan

The PGDx elio plasma focus Dx offers laboratories testing options for situations where samples are hard to obtain.

FDA granted De Novo marketing authorization to Labcorp for its kitted, pan-solid tumor liquid biopsy test.1 The PGDx elio plasma focus Dx provides laboratories with the ability to perform genomic profiling in situations when obtaining sample tissue is difficult or impossible.

According to Labcorp, the test is capable of detecting various biomarkers across 33 genes, CNAs in five genes, and translocations in three genes.

In a press release, Labcorp vice president and medical lead for oncology Shakti Ramkissoon, MD, PhD, MBA, said, “The launch of PGDx elio plasma focus Dx represents a landmark expansion of Labcorp’s suite of precision oncology solutions. This...

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Topics: FDA, Govt Agencies, Pharma / Biotech, Precision Medicine
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