Monitor for commercial adoption metrics, Medicare coverage decisions for SimpleScreen Lung, and any future FDA submission for the lung test. The bundled CRC+Lung offering could drive incremental SimpleScreen CRC volumes via cross-selling at primary care visits.
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Executive Summary
Freenome announced the launch of SimpleScreen Lung, a laboratory-developed blood test for lung cancer screening, alongside its FDA-approved SimpleScreen CRC test, enabling a single blood draw for both lung and colorectal cancer screening. The test demonstrated 85% sensitivity at 50% specificity and a 99.8% negative predictive value in a validation cohort of 172 lung cancer cases and 436 controls. This product launch expands Freenome's addressable market into lung cancer screening, but the test is not FDA-cleared and the filing contains no financial data or revenue guidance.
Key Facts
- Launched SimpleScreen Lung, a laboratory-developed test (LDT) for lung cancer screening in adults 50-80 with 20+ pack-year smoking history
- SimpleScreen Lung achieved 85% sensitivity at 50% specificity and 99.8% NPV in an independent cohort of 172 cases and 436 controls
- Stage-specific sensitivity: 82% stage I, 75% stage II, 91% stage III, 94% stage IV
- SimpleScreen CRC (FDA-approved) showed 81% sensitivity for CRC, 90% specificity for advanced neoplasia, 99.9% NPV in PREEMPT CRC study (48,000+ participants)
- Abbott holds exclusive U.S. commercial rights to standalone SimpleScreen CRC
- SimpleScreen Lung has not been reviewed or cleared/approved by the FDA
- No financial data, revenue, or guidance provided in the filing
Financial Impact
No financial figures disclosed; product launch expands addressable market into lung cancer screening (estimated >10 million eligible individuals not up to date with LDCT screening per filing)
Risk Factors
- SimpleScreen Lung is an LDT not FDA-cleared, limiting reimbursement and guideline inclusion
- No revenue or pricing data disclosed; commercial traction uncertain
- Competitive landscape includes existing LDCT screening and other blood-based lung cancer tests (e.g., Exact Sciences, Guardant Health)
- Abbott's exclusive rights to standalone SimpleScreen CRC may limit Freenome's direct-to-market revenue from CRC
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001140361-26-040186 |
| Document: ef20084075_ex99-1.htm | 0001140361-26-040186 |
| Document: 0001140361-26-040186-index-headers.html | 0001140361-26-040186 |
| Document: 0001140361-26-040186-index.html | 0001140361-26-040186 |
| Document: 0001140361-26-040186.txt | 0001140361-26-040186 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 20, 2026 6d ago | 8-K | $14.06 $14.01 | ▼ −0.36% | ▼ −0.88% | $12.72 (−9.53%) |
Oct 15, 2026 11d ago | Press Release | $11.75 $12.57 | ▲ +6.98% | ▲ +6.56% | $12.72 (+8.26%) |
Aug 28, 2026 8w ago | EFFECT | $14.79 $14.79 | · 0.00% | ▲ +0.30% | $12.72 (−14.00%) |
Aug 18, 2026 9w ago | S-1 | $13.63 $13.51 | ▼ −0.88% | ▼ −0.04% | $12.72 (−6.68%) |
Jul 27, 2026 12w ago | 3 | $10.77 $10.06 | ▼ −6.59% | ▼ −5.05% | $12.72 (+18.11%) |
Jul 23, 2026 13w ago | 8-K | $11.24 $11.38 | ▲ +1.25% | ▲ +1.22% | $12.72 (+13.17%) |
Jul 20, 2026 14w ago | Press Release | $13.01 $13.14 | ▲ +1.00% | ▲ +1.12% | $12.72 (−2.23%) |
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