Comprehensive analysis of FDA status, 2024 revenue performance, Medicare/Medicaid coverage, pricing structure, and biomarker technologies across all commercial and in-development diagnostic tests
| Test Name | FDA Status | 2024 Revenue | Medicare Coverage | Medicaid Coverage | Private Insurance | Self-Pay Price | Patient Cost | Biomarker Type | Launch Date |
|---|---|---|---|---|---|---|---|---|---|
| Cologuard (Original) | FDA APPROVED PMA P130017 (Aug 2014) |
~$2.0B 4M+ tests |
YES NCD 210.3, $493 reimb. |
YES $0 cost sharing (CA) |
Broadly Covered 96%+ patients $0 OOP |
$649 | 96% pay $0 (ages 45+) Medicare: $0 when criteria met |
DNA methylation (NDRG4, BMP3) DNA mutations (7 KRAS) Protein (Hemoglobin) 11 total biomarkers |
August 2014 Expanded to 45+ in May 2019 |
| Cologuard Plus | FDA APPROVED PMA P230043 (Oct 2024) |
Minimal Launched March 2025 |
YES CPT 0464U, $592 reimb. |
YES In-network (CA) |
Expanding MA transitioning, parity by 2026 |
$790 | ~$0 for most Similar to Cologuard Medicare: $0 when criteria met |
DNA methylation (LASS4, LRRC4, PPP2R5C) Protein (Hemoglobin) 5 total biomarkers |
March 2025 FDA approved Oct 2024 |
| Oncotype DX Breast | LDT - NOT FDA APPROVED CLIA/CAP certified |
~$600M+ ~200K+ patients (est.) |
YES CPT 81519, $3,416 reimb. |
YES Available to Medicaid |
Broadly Covered All major insurers |
$3,454 (GSA Schedule) |
86% pay $0 91% pay <$100 Medicare FFS: $0 when criteria met |
mRNA expression (21 genes) 16 cancer-related + 5 reference Includes ER, PR, HER2, Ki-67 |
2004 Acquired by EXAS 2019 |
| Oncotype DX DCIS | LDT - NOT FDA APPROVED CLIA/CAP certified |
Included in Oncotype Part of 230K patients |
YES Part of Oncotype coverage |
YES Available to Medicaid |
Covered Major insurers |
~$3,400 | Similar to Breast Most pay $0-$100 |
mRNA expression (12 genes) 7 cancer-related + 5 reference Ki-67, AURKA, BIRC5, etc. |
December 2011 Acquired by EXAS 2019 |
| Oncotype DX Colon | LDT - NOT FDA APPROVED CLIA/CAP, PLA 81525 |
Included in Oncotype Part of 230K patients |
YES Part of Oncotype coverage |
YES Available to Medicaid |
Covered Major insurers |
~$3,400 | Similar coverage Most pay $0-$100 |
mRNA expression (12 genes) 7 cancer-related + 5 reference Stromal, cell cycle genes |
January 2010 Acquired by EXAS 2019 |
| OncoExTra | LDT - NOT FDA APPROVED CLIA/CAP certified |
~$30-40M ~5% of Precision Oncology |
YES NCD 90.2, NGS codes |
Available Follows Medicare |
Broadly Covered 150M+ lives, 98% $0 OOP |
~$3,500 (est., not disclosed) |
98% pay $0 for NGS component IHC add-ons may have cost |
DNA sequencing (WES ~20K genes) RNA sequencing (Whole transcriptome) Mutations, CNVs, fusions, TMB |
February 2023 Launched Feb 7, 2023 |
| Oncodetect MRD | LDT - NOT FDA APPROVED CLIA/CAP certified |
N/A Launched April 2025 |
YES MolDX LCDs (CRC only) |
Likely YES Follows Medicare |
Expanding Major insurers adding coverage |
~$3,000 (analyst estimate) |
Medicare FFS: $0 Commercial coverage expanding 150K+ addressable annually |
ctDNA (Tumor-informed) Tracks up to 200 patient variants 1 in 20,000 cfDNA sensitivity |
April 2025 Medicare coverage July 2025 |
| Cancerguard MCED | LDT - NOT FDA APPROVED FDA IDE for FALCON study |
N/A Launched Sept 2025 |
NO Investigational status |
NO Not covered |
NO Investigational by most insurers |
$689 | $689 (full self-pay) No insurance coverage FSA/HSA eligible |
ctDNA methylation Protein biomarkers (9 proteins) CA-125, CEA, CA19-9, PSA, etc. |
September 10, 2025 $689 self-pay |
| Riskguard | LDT - NOT FDA APPROVED CLIA/CAP certified |
Part of Screening Included in $2.1B segment |
YES NCD 90.2/LCD L38972 |
YES TAR may be required |
Covered UHC, Anthem, Cigna, Humana |
Not disclosed Insurance-billed test |
Medicare: $0 when criteria met Commercial: similar coverage No self-pay price published |
Germline DNA sequencing 59 hereditary cancer genes 10+ cancer types assessed |
February-March 2024 Launched Feb 28, 2024 |
| PreventionGenetics Portfolio | LDT - NOT FDA APPROVED 5,000+ distinct tests |
$36M 2021 acquisition revenue; 2024 not disclosed separately |
YES Varies by test |
YES Varies by test, TAR required |
Covered Varies by test and insurer |
$540-$1,290 Cancer panels: $540-590 WES: $1,290 Most tests: ≤$990 |
Medicare: $0 when criteria met Commercial widely covered +25% STAT fee |
Germline DNA/RNA WES (PGxome), WGS (PGnome) Custom gene panels available |
Acquired Dec 2021 Founded 2004 |
| Oncoguard Liver (HCC) | IN DEVELOPMENT Breakthrough Device (2019) |
N/A Early access only |
N/A Not launched commercially |
N/A Not launched commercially |
N/A Not launched commercially |
TBD | N/A Not launched |
cfDNA methylation Protein (AFP) 88% CRC sensitivity reported |
In Development Launch timing TBD |
| Blood-based CRC Screening | DISCONTINUED Failed Medicare threshold Aug 2025 |
N/A Internal test discontinued |
NO 73% CRC sensitivity (below 74% threshold) |
NO Did not meet coverage requirements |
NO Failed Medicare threshold |
N/A | N/A Test discontinued |
cfDNA methylation AI-based multiomics Aug 2025: 73% CRC, 14% APL sensitivity at 90% specificity |
August 2025 Results below Medicare 74% threshold; licensed Freenome test instead |
| Freenome Blood CRC Test | IN DEVELOPMENT PMA submitted, pending approval |
N/A Licensed Aug 2025 |
N/A Pending FDA approval |
N/A Pending FDA approval |
N/A Pending FDA approval |
TBD | N/A Pending approval |
ctDNA methylation Multiomics platform 81.1% CRC sensitivity (PREEMPT) |
Expected 2026 Licensed from Freenome |