The Diagnostics & Lab Testing Business Brief — Tuesday, November 3, 2026

From The Diagnostics & Lab Testing Business Brief · 6:09

Show by Damon Frank

The Diagnostics & Lab Testing Business Brief — Tuesday, November 3, 2026 The business behind the tests. Today's developments shaping the diagnostics industry. Natera Signatera MRD test gains Medicare coverage in hepatocellular carcinoma: Medicare coverage through the CMS MolDX program includes serial Signatera testing in the surveillance setting for patients with early-stage HCC with no post-surgical evidence of disease; supported by a 125-patient real-world study in JCO Precision Oncology showing 83% sensitivity vs. 42% for AFP at 100% specificity, with a median lead time of 7.9 months ahead of imaging. Source: Business Wire — Medicare Expands Coverage for Signatera MRD Test in Hepatocellular Carcinoma, Nov 3, 2026 Revvity reports third-quarter 2026 results: total revenue $729 million (vs. $699 million a year earlier), GAAP EPS $0.56, adjusted EPS $1.38; Diagnostics revenue $349 million, with pro forma Diagnostics revenue +4% (organic +5%) and segment adjusted operating margin of 29.9%; full-year pro forma revenue forecast of ~$2.86 billion and adjusted EPS of $5.40–$5.45. Source: Business Wire — Revvity Announces Financial Results for the Third Quarter of 2026, Nov 3, 2026 Roche receives FDA 510(k) clearance for cobas eplex respiratory pathogen panel 3 (RP3): clearance (not approval) for a syndromic panel detecting up to 19 viral and bacterial targets from a single nasopharyngeal swab, adding Bordetella pertussis and updated influenza and SARS-CoV-2 assays, with up to five customizable panel configurations and results in under two hours; the earlier RP2 panel remains under Emergency Use Authorization. Source: Roche Diagnostics — FDA 510(k) Clearance for cobas eplex Respiratory Pathogen Panel 3, Nov 2, 2026 CareDx publishes third KOAR analysis in Transplantation: in 1,137 kidney transplant recipients across 56 centers, persistent AlloSure Kidney dd-cfDNA elevation in the first four months post-transplant was associated with a nine-fold higher incidence of allograft loss vs. consistently low levels, while transient elevations that resolved were not associated with worse outcomes. Source: Business Wire — CareDx Announces Third KOAR Analysis Published in Transplantation, Nov 3, 2026 OGT expands IVDR-certified CytoCell FISH probe range: four newly IVDR-certified probes (ATM Deletion, IGH Plus Breakapart, IGH/FGFR3 Plus, and IGH/MYEOV Plus) for hematological malignancies including non-Hodgkin lymphoma, acute lymphoblastic leukemia, chronic lymphocytic leukemia, and multiple myeloma, ahead of the Class C IVDR deadline of December 31, 2028. Source: News-Medical — OGT Expands Range of CytoCell IVDR-Certified FISH Probes for Hematological Malignancies, Nov 3, 2026 (announced Nov 2)

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