Tempus AI has won FDA clearance for the first US companion diagnostic approved for both tumour-only and tumour-normal genomic profiling, expanding its 648-gene xT CDx assay for solid tumours and colorectal cancer therapy selection. The move lets the assay assess microsatellite instability from tumour-only genomic data and positions Tempus to shift its DNA solid tumour portfolio onto FDA-approved tests with an expected $200 average selling price lift per test starting in 2027.

Why It Matters To Oncology

• Tempus xT CDx was first cleared in 2023, but initially required a matched normal sample; the new label adds tumour-only use when a normal comparator is unavailable.

• For clinicians, that adds flexibility in real-world workflows, especially when blood or adjacent normal tissue cannot be collected.

• The assay profiles all solid tumours and serves as a CDx in colorectal cancer to help identify patients for EGFR-targeted therapies including cetuximab and panitumumab.

• Tumour-only MSI assessment could broaden access to actionable genomic testing in routine practice.

The Financials

• Tempus said the clearance should help migrate its full DNA solid tumour portfolio to FDA-approved assays under its current ADLT pricing structure.

• CFO Jim Rogers said the company expects an estimated $200 average selling price benefit per test beginning in 2027.

• The approval also strengthens the commercial case for integrating regulated diagnostics with Tempus AI's broader oncology data and analytics business.

What They're Saying

• Chief Scientific Officer Kate Sasser said the test offers “flexibility for a range of clinical scenarios.”

• Sasser added that tumour-normal matched sequencing “remains an important approach,” but matched normal samples are not always available.

• The FDA clearance underscores a growing regulatory comfort with tumour-only approaches when analytically validated for specific use cases.

What's Next

• Watch for how quickly Tempus converts ordering volume from laboratory-developed testing to FDA-cleared assays across its solid tumour menu.

• In drug discovery, the clearance could make Tempus a more attractive biomarker and patient-selection partner for oncology trials.

• That matters as Tempus expands pharma ties, including recent deals with Bristol Myers Squibb, Daiichi Sankyo and Merck & Co.

• Clinicians should also watch whether broader tumour-only regulatory pathways emerge for other genomic profiling platforms.