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30 juli 2026: Bron: JAMA FDA en persbericht van Freenome, Inc.

De Food and Drug Administration (FDA) heeft de bloedtest SimpleScreen™ van Freenome goedgekeurd - zie NCT04369053. SimpleScreen™  is een ctDNA bloedtest voor de vroege opsporing van darmkanker bij volwassenen van 45 jaar en ouder met een gemiddeld risico op de ziekte. De goedkeuring van de SimpleScreen™ darmkankertest werd ondersteund door gegevens uit de PREEMPT darmkanker studie, waaraan 48.995 volwassenen deelnamen met asymptomatische = geen aantoonbare darmkanker van 45 tot 85 jaar met een gemiddeld risico op ontstaan van darmkanker of kwaadaardige darmpoliepen en die bereid waren een routinematige screeningscolonoscopie te ondergaan na bloedafname.

De niet-invasieve ctDNA bloedtest detecteert moleculaire signalen die geassocieerd zijn met darmkanker in het bloed, op basis van celvrij DNA. Een positief resultaat moet worden opgevolgd met een colonoscopie, aangezien ook de bloedtest SimpleScreen™  geen vervanging is voor een diagnostische colonoscopie of voor een surveillance-colonoscopie bij personen met een hoog risico.

De primaire uitkomsten waren:

De volgende resultaten werden waargenomen bij deelnemers in het evalueerbare studiegroep (n=27.010 deelnemers; mediane leeftijd, 57 jaar; 55,8% vrouwen):
  • Gevoeligheid voor darmkanker: 79,2% (57/72; 95% BI, 68,4-86,9)
  • Darmkanker Stadium I: 57,1% (16/28; 95% BI, 39,1-73,5)
  • Darmkanker Stadium II: 100% (15/15; 95% BI, 79,6-100)
  • Darmkanker Stadium III: 82,4% (14/17; 95% BI, 59-93,8)
  • Darmkanker Stadium IV: 100% (11/11; 95% BI, 74,1-100)
  • Onbekend stadium: 100% (1/1; 95% BI, 20,7-100)
  • Specificiteit voor gevorderde darm neoplasie: 91,5% (22.306/24.371; 95% betrouwbaarheidsinterval, 91,2-91,9);
  • NPV = Negatieve voorspellende waarde voor gevorderde darm neoplasie: 90,8% (22.306/24.567; 95% betrouwbaarheidsinterval, 90,7-90,9);
  • PPV = Positieve voorspellende waarde voor gevorderde darm neoplasie: 15,5% (378/2443; 95% betrouwbaarheidsinterval, 14,2-16,8)
  • Gevoeligheid voor gevorderde voorstadia van kanker (secundair eindpunt): 12,5% (321/2567; 95% betrouwbaarheidsinterval, 11,3-13,8).

Omdat de de bloedtest SimpleScreen™ bij volwassenen woonachtig in Amerika werd onderzocht kwamen de onderzoekers met de volgende conclusie:

Na aanpassing aan de demografische gegevens van de Amerikaanse volkstelling bedroegen de prestatiecijfers een gevoeligheid van 81,1% voor darmkanker en een gevoeligheid van 13,7% voor gevorderde voorstadia van kanker.

Alle primaire eindpunten voldeden aan de vooraf vastgestelde acceptatiecriteria.

Bovenstaande is gedeeltelijk uit het persbericht van Freenome Inc. gehaald en vertaald in het Nederlands. Klik voor het originele persbericht op de volgende link: 

FDA Approves Freenome’s SimpleScreen™ CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S.

– Approval expands colorectal cancer screening options for the up to 60 million Americans who are overdue for screening –

– Medicare coverage and American Cancer Society guidance support broader access to blood-based colorectal cancer screening –

De studiegegevens van de PREEMPT darmkanker studie werden vorig jaar juli 2025 in JAMA gepubliceerd en studieverslag is gratis in te zien of te downloaden.

Abstract

Importance: Colorectal cancer screening is widely recommended but underused. Blood-based screening offers the potential for higher adherence compared with endoscopy or stool-based testing but must first be clinically validated in a screening population.

Objective: To evaluate the clinical performance of an investigational blood-based circulating tumor DNA test for colorectal cancer detection in an average-risk population using colonoscopy with histopathology as the reference method.

Design, setting, and participants: Prospective, multicenter, cross-sectional observational study enrolling participants between May 2020 and April 2022 who were asymptomatic adults aged 45 to 85 years, at average risk of colorectal cancer, and willing to undergo a standard-of-care screening colonoscopy. Participants, staff, and pathologists were blinded to blood test results, and laboratory testing was performed blinded to colonoscopy findings. The study was conducted at 201 centers across 49 US states and the United Arab Emirates. Site-based and mobile phlebotomy were used for blood collection.

Exposures: Participants were required to complete a screening colonoscopy after blood collection.

Main outcomes and measures: The primary end points were sensitivity for colorectal cancer, specificity for advanced colorectal neoplasia (colorectal cancer or advanced precancerous lesions), negative predictive value for advanced colorectal neoplasia, and positive predictive value for advanced colorectal neoplasia. The secondary end point was sensitivity for advanced precancerous lesions.

Results: The median age of participants in the evaluable cohort (n = 27 010) was 57.0 years, and 55.8% were women. Sensitivity for colorectal cancer was 79.2% (57/72; 95% CI, 68.4%-86.9%) and specificity for advanced colorectal neoplasia was 91.5% (22 306/24 371; 95% CI, 91.2%-91.9%). The negative predictive value for advanced colorectal neoplasia was 90.8% (22 306/24 567; 95% CI, 90.7%-90.9%) and the positive predictive value for advanced colorectal neoplasia was 15.5% (378/2443; 95% CI, 14.2%-16.8%). All primary end points met prespecified acceptance criteria. The sensitivity for advanced precancerous lesions was 12.5% (321/2567; 95% CI, 11.3%-13.8%), which did not meet the prespecified acceptance criterion.

Conclusions and relevance: In an average-risk colorectal cancer screening population, a blood-based test demonstrated acceptable accuracy for colorectal cancer detection, but detection of advanced precancerous lesions remains a challenge, and ongoing efforts are needed to improve test sensitivity.

Trial registration: ClinicalTrials.gov Identifier: NCT04369053.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Shaukat reported receipt of personal fees from Freenome Holdings Inc, Geneoscopy, Iterative Health, and UniversalDx. Dr Burke reported receipt of research funding from Emtora; receipt of consulting fees from Sebela, Guardant, Almirall, Lumabridge, Freenome Holdings Inc, and Janssen; speaker fees from Ambry; receipt of other fees from AbbVie, Medtronic, Myriad, Genzyme, Ferring, Salix, and Merck; and serving as a member of the US Multi-Society Task Force on Colorectal Cancer and National Comprehensive Cancer Network Guideline on Genetic/Familial High-Risk Assessment: Colorectal, Endometrial, and Gastric. Dr Chan reported receipt of grants from Pfizer Inc, consulting fees from Pfizer Inc and Boehringer Ingelheim, and honoraria from UpToDate. Dr Grady reported receipt of consulting fees from Karius, Diacarta, Guardant Health, Natera, and Freenome Holdings Inc; honoraria from UpToDate; and research support from Lucid Diagnostics. Dr Gupta reported receipt of consulting fees from Guardant Health, Geneoscopy, Universal Diagnostics, CellMax, and InterVenn. Dr Katona reported receipt of research funding from Janssen, Immunovia, Epigenomics, Guardant Health, Freenome Holdings Inc, Universal Diagnostics, and Recursion (paid to his institution) and membership on an advisory board for Immunovia. Dr Ladabaum reported receipt of consulting fees from ChekCap, Guardant Health, Freenome Holdings Inc, Neptune Medical, Medacorp, Mosaic, William Blair, Guidepoint, Medial EarlySign, Geneoscopy, and Medtronic; membership on advisory boards for UniversalDx, Lean Medical, Cylinder, Lumiinus, and Kohler Ventures; stock options in UniversalDx, Cylinder, and Lumiinus; and equity in Lean Medical. Dr Liang reported receipt of consulting fees from Guardant Health and Natera. Dr Putcha reported equity in Freenome Holdings Inc and being an employee of Freenome Holdings Inc at the time the study and analyses were conducted. Dr Robertson reported receipt of consulting fees from and serving on a publication steering committee for Freenome Holdings Inc and receipt of personal fees from Topography. Dr Schoen reported receipt of research support from Exact Sciences, Freenome Holdings Inc, and Immunovia and advisory support from Guardant Health. Dr Meng reported being an employee of Freenome Holdings Inc. Mr Piscitello reported receipt of consulting fees from Bluestar Genomics, Elephas, Nucleix, Caris, Karius, Thermo Fisher Scientific, Viome, Iterative Scopes, Innovenn, and Medtronic prior to employment with Freenome Holdings Inc. Mr Sun reported being an employee of Freenome Holdings Inc. Dr Xu reported being an employee of Freenome Holdings Inc at the time the study and analyses were conducted. Dr Lin reported being an employee of Freenome Holdings Inc. Dr Lee reported being an employee of Freenome Holdings Inc. Dr Baldo reported being an employee of Freenome Holdings Inc at the time the study and analyses were conducted. Dr Levin reported receipt of research funding from the Patient-Centered Outcomes Research Institute and Freenome Holdings Inc; employment with Permanente Medical Group; participation on a data safety monitoring board/advisory board for the CONFIRM trial (NCT01239082); and having an unpaid leadership/fiduciary role with the California Colorectal Cancer Coalition. No other disclosures were reported.

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Bloedtest SimpleScreen™, preventie, darmkanker, volwassenen van 45 jaar en ouder, PREEMPT CRC studie, FDA goedkeuring, Abbott


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