Dive Brief:

• Labcorp has received de novo authorization for a kitted, pan-solid tumor liquid biopsy test, the company said Friday.
• The product, PGDx elio plasma focus Dx, is a targeted blood test that profiles 33 cancer genes.
• Securing Food and Drug Administration authorization expands the cancer portfolio that Labcorp has built since buying Personal Genome Diagnostics (PGDx) for $450 million in 2022.

Dive Insight:

PGDx received FDA clearance for a tissue-based test, PGDx elio tissue complete, in 2020. Labcorp made the tumor profiling service available in Geneva and Shanghai in June to support global clinical trials.

In parallel, the company worked to bring a liquid biopsy test to the U.S. market. The liquid biopsy lacks the breadth of the tissue-based test, which assesses 505 genes related to solid tumor genes, but could allow laboratories and oncologists to profile solid tumors when tissue samples are limited or unavailable.

“When paired with PGDx elio tissue complete, Labcorp now offers laboratories access to tissue and liquid genomic-profiling assays that operate on the same instrument, enabling seamless integration of these precision oncology products into routine laboratory workflows,” Shakti Ramkissoon, Labcorp’s medical lead for oncology, said at a statement.

The liquid biopsy panel is designed to detect single nucleotide variants, insertions and deletions in 33 genes. Copy number amplifications are available for five of the genes. The test looks at translocations in three of the genes. Labcorp has a more comprehensive liquid biopsy test, PGDx elio plasma complete, that more closely matches the tissue-based kit, but the diagnostic is only sold for research use.

Labcorp has acquired businesses to support the oncology expansion, buying PGDx in 2022 and Invitae assets this year.

Labcorp expects Invitae to provide revenue of from $275 million to $300 million and be dilutive by around 3% in the first year, CEO Adam Schechter said on an earnings call Thursday. Schechter said the acquired inherited cancer assets, which he expects to achieve top-line growth of more than 10% in 2025, could benefit Labcorp’s sales teams because they have a broader portfolio of products.

“It’s one thing to go into an office and talk about inherited cancers. It’s another thing to say, ‘But you can also test for all the other things that you may want to test that patient for,’” Schechter said. “Ultimately, we’re going to try to bring that all together so the physician can order directly through one tool and get whatever they need for the patients.”