September 23, 2026

Update to our PD-L1 28-8 (OPDIVO®) for Gastric/GEJ/EAC testing — effective Wednesday, September 23, 2026.

The FDA recently approved an expanded use of the PD-L1 IHC 28-8 pharmDx assay as a companion diagnostic for OPDIVO® therapy across certain upper gastrointestinal and esophageal cancer indications. As part of this update, the PD-L1 Combined Positive Score, or CPS, threshold has changed from CPS ≥5 to CPS ≥1 for applicable gastric and gastroesophageal junction adenocarcinoma cases. Additional esophageal indications are also now included. To align with these updated criteria, NeoGenomics is updating the test name to: PD-L1 28-8 CDx for Gastric/Esophageal This update applies to the following indications: Gastric adenocarcinoma Gastroesophageal junction, or GEJ, adenocarcinoma Esophageal adenocarcinoma Esophageal squamous cell carcinoma, or ESCC All covered indications now use a CPS ≥1 threshold. If you have questions, please contact NeoGenomics Client Services at client.services@neogenomics.com.

More comprehensive insights from the heme tests you already trust

Now with broader genomic coverage, expanded reporting sensitivity, and faster turnaround times, Neo Comprehensive® – Heme Cancers and Neo Comprehensive® – Myeloid Disorders offer greater insight and confidence while maintaining the trusted testing you rely on. What's new: Expanded guideline-driven genomic coverage: UBA1 added to support complex MDS cases Expanded variant allele frequency (VAF) reporting: Hotspot mutations and 50 CHIP-associated genes now reported at 3% VAF Faster results: Comprehensive results in a single report delivered in as few as 8 days* What this means for you: Greater visibility into low-frequency variants Broader genomic coverage through UBA1 inclusion More comprehensive molecular characterization Faster access to comprehensive genomic insights The same trusted quality and expertise from NeoGenomics Enhanced support for complex patient management decisions Additionally, to support ongoing optimization of assay content, a small number of low-clinical-utility targets, including SBDS, CHD1, and ZEB2, have been removed while overall coverage and performance have been enhanced. *Turnaround time for these tests is 8–11 days