NeoGenomics Debuts FDA-Approved PTEN IHC Companion Diagnostic for Prostate Cancer
NEO•NeoGenomics launched the first FDA-approved PTEN immunohistochemistry companion diagnostic for prostate cancer, enabling precise detection of PTEN loss in tumor samples. The assay complements its oncology testing portfolio and targets a sizable prostate cancer patient base, potentially driving incremental lab revenue and strengthening diagnostics offerings.
1. FDA Approval and Launch
On July 9, 2026, NeoGenomics received FDA approval for its PTEN IHC companion diagnostic designed specifically for prostate cancer and immediately initiated commercial rollout to clinical laboratories.
2. Diagnostic Test Features
The assay applies immunohistochemistry staining to formalin-fixed, paraffin-embedded prostate tumor samples to detect loss of the PTEN tumor suppressor protein, offering clinicians actionable biomarker information for therapy selection.
3. Market and Revenue Potential
By targeting the prostate cancer patient segment that requires molecular profiling, the new test is positioned to increase lab service volumes and contribute to recurring diagnostic revenues for NeoGenomics.
4. Strategic Portfolio Impact
This FDA-cleared companion diagnostic expands NeoGenomics’ solid tumor and immuno-oncology testing suite, enhancing its value proposition to pharmaceutical partners developing targeted therapies.
