Diagnostics & Biomarkers

After cancer surgery or chemotherapy, tiny amounts of remaining cancer (minimal residual disease or MRD) often recur months to years later. ctDNA blood tests can detect MRD, but sensitivity varies by cancer type, and it's unclear whether MRD-guided treatment decisions improve outcomes compared to standard protocols.

Tuberculosis kills 1.3M people/year (2nd deadliest infectious disease after COVID). In low-resource settings where 95% of TB deaths occur, the primary diagnostic (sputum smear microscopy) misses 40-60% of cases, especially in HIV co-infected and pediatric patients.

Ovarian cancer is the deadliest gynecological cancer because there is no effective screening test. CA-125 blood test and transvaginal ultrasound have been tested extensively but failed to reduce mortality in large RCTs. 70%+ of cases are diagnosed at Stage III/IV where 5-year survival is only 30%.

Sepsis kills ~270,000 Americans annually and is the most expensive hospital condition. Current biomarkers (CRP, procalcitonin, IL-6) lack specificity and take hours to return results. There is no rapid point-of-care test that reliably detects sepsis before organ failure begins.

The first FDA-cleared blood test for Alzheimer's (Lumipulse G p-tau217/Aβ1-42 ratio, May 2025) achieves 91.7% concordance with amyloid PET scans. But it's only cleared for symptomatic patients 55+, and real-world performance in diverse populations, primary care settings, and early pre-symptomatic stages remains unclear.

Pancreatic cancer is diagnosed late in >80% of cases because there is no screening test for the general population. 5-year survival is below 12% overall, but screening programs report 24-73% 5-year survival when caught early. A new 4-biomarker blood test (ANPEP, PIGR, CA19-9, THBS2) achieved 91.9% accuracy in a 2026 study.

GRAIL's Galleri test can detect 50+ cancer types from a blood draw, but sensitivity varies dramatically by cancer stage and type — high for late-stage cancers but potentially missing many early-stage ones. GRAIL submitted FDA PMA in January 2026 with data from 25,490 PATHFINDER 2 participants and 140,000+ NHS-Galleri trial participants. Over 475,000 commercial tests sold.