Hologic has launched Genoptix Clarity, a multi-cancer early detection (MCED) liquid biopsy test that screens for 12 cancer types including lung, colorectal, ovarian and pancreatic cancer from a single blood sample using AI-driven methylation analysis.
Hologic has commercially launched Genoptix Clarity, a multi-cancer early detection (MCED) blood test that identifies 12 cancer types at early stages before symptoms develop, using AI analysis of circulating tumour DNA methylation patterns.
The test, developed through Hologic's Genoptix subsidiary, analyses over 350,000 methylation markers across the genome to detect cancer-specific epigenetic signatures and predict the tissue of origin with 93% accuracy.
Cancers Detected
Lung, colorectal, ovarian, pancreatic, oesophageal, gastric, liver, bladder, kidney, uterine, head/neck and multiple myeloma — including types with no established screening test.
Clinical Performance
- Sensitivity: 88% overall; 94% for Stage I-II
- Specificity: 99.4% (0.6% false positive rate)
- Tissue of origin accuracy: 93%
- Performance validated in 14,000-participant DETECT study
The test is available through physician ordering for $949 and is processed at Hologic's CLIA-certified Genoptix laboratory. Medicare coverage discussions are ongoing, with a decision expected by Q4 2026.