Immunovia provides further positive data from the VERIFI study of its next-generation pancreatic cancer test
Immunovia has announced additional positive results from its VERIFI study for its next-generation pancreatic cancer blood test. The test demonstrated 77% sensitivity in detecting stage I and II pancreatic cancer, exceeding the target of 65% and outperforming the CA19-9 biomarker's 69% sensitivity.
The test showed 88% specificity, slightly below the 90% target but comparable to CA19-9's 89%. Combined data from VERIFI and CLARITI validation studies demonstrated consistent accuracy across various high-risk groups, including individuals with family history, genetic mutations, diabetes, and pancreatic cysts.
The company plans to launch the test commercially in Q3 2025, with additional clinical studies planned throughout the year to support regulatory submissions and payer reimbursement efforts. Immunovia is also seeking commercial partners to accelerate market adoption.
Immunovia ha annunciato ulteriori risultati positivi dal suo studio VERIFI per il suo test del sangue di nuova generazione per il cancro pancreatico. Il test ha dimostrato una sensibilità del 77% nella rilevazione del cancro pancreatico di stadio I e II, superando l'obiettivo del 65% e superando la sensibilità del biomarker CA19-9, che è del 69%.
Il test ha mostrato una specificità dell'88%, leggermente al di sotto dell'obiettivo del 90%, ma comparabile al 89% del CA19-9. I dati combinati degli studi di validazione VERIFI e CLARITI hanno dimostrato un'accuratezza costante tra vari gruppi ad alto rischio, inclusi individui con storia familiare, mutazioni genetiche, diabete e cisti pancreatiche.
L'azienda prevede di lanciare il test commercialmente nel terzo trimestre del 2025, con ulteriori studi clinici pianificati nel corso dell'anno per supportare le sottomissioni regolatorie e gli sforzi di rimborso da parte dei pagatori. Immunovia sta anche cercando partner commerciali per accelerare l'adozione del mercato.
Immunovia ha anunciado resultados positivos adicionales de su estudio VERIFI para su prueba de sangre de próxima generación para el cáncer de páncreas. La prueba demostró una sensibilidad del 77% en la detección del cáncer de páncreas en las etapas I y II, superando el objetivo del 65% y superando la sensibilidad del biomarcador CA19-9, que es del 69%.
La prueba mostró una especificidad del 88%, ligeramente por debajo del objetivo del 90%, pero comparable al 89% del CA19-9. Los datos combinados de los estudios de validación VERIFI y CLARITI demostraron una precisión constante en varios grupos de alto riesgo, incluidos individuos con antecedentes familiares, mutaciones genéticas, diabetes y quistes pancreáticos.
La empresa planea lanzar la prueba comercialmente en el tercer trimestre de 2025, con estudios clínicos adicionales planeados a lo largo del año para apoyar las presentaciones regulatorias y los esfuerzos de reembolso de los pagadores. Immunovia también está buscando socios comerciales para acelerar la adopción en el mercado.
Immunovia는 차세대 췌장암 혈액 검사에 대한 VERIFI 연구의 추가 긍정적인 결과를 발표했습니다. 이 검사는 췌장암 1기 및 2기 검출에서 77%의 민감도를 보여주었으며, 목표인 65%를 초과하고 CA19-9 바이오마커의 69% 민감도를 능가했습니다.
검사는 88%의 특이성을 보였으며, 90% 목표에는 미치지 못하지만 CA19-9의 89%와 유사합니다. VERIFI와 CLARITI 검증 연구의 결합 데이터는 가족력, 유전적 돌연변이, 당뇨병 및 췌장 낭종을 포함한 다양한 고위험 그룹에서 일관된 정확성을 입증했습니다.
회사는 2025년 3분기에 상업적으로 검사를 출시할 계획이며, 규제 제출 및 지불자 환급 노력을 지원하기 위해 연중 추가 임상 연구를 계획하고 있습니다. Immunovia는 시장 채택을 가속화하기 위해 상업적 파트너를 찾고 있습니다.
Immunovia a annoncé des résultats positifs supplémentaires de son étude VERIFI pour son test sanguin de nouvelle génération pour le cancer du pancréas. Le test a démontré une sensitivity de 77% dans la détection des cancers du pancréas de stade I et II, dépassant l'objectif de 65% et surpassant la sensibilité du biomarqueur CA19-9 qui est de 69%.
Le test a montré une spécificité de 88%, légèrement en dessous de l'objectif de 90%, mais comparable aux 89% du CA19-9. Les données combinées des études de validation VERIFI et CLARITI ont montré une précision constante à travers divers groupes à haut risque, y compris les individus ayant des antécédents familiaux, des mutations génétiques, du diabète et des kystes pancréatiques.
L'entreprise prévoit de lancer le test commercialement au troisième trimestre 2025, avec des études cliniques supplémentaires prévues tout au long de l'année pour soutenir les soumissions réglementaires et les efforts de remboursement des payeurs. Immunovia recherche également des partenaires commerciaux pour accélérer l'adoption sur le marché.
Immunovia hat zusätzliche positive Ergebnisse aus seiner VERIFI-Studie für seinen Bluttest der nächsten Generation auf Bauchspeicheldrüsenkrebs angekündigt. Der Test zeigte eine Empfindlichkeit von 77% bei der Erkennung von Bauchspeicheldrüsenkrebs im Stadium I und II, übertraf das Ziel von 65% und übertraf die Empfindlichkeit des Biomarkers CA19-9 von 69%.
Der Test zeigte eine Spezifität von 88%, leicht unter dem Ziel von 90%, aber vergleichbar mit den 89% von CA19-9. Kombinierte Daten aus den Validierungsstudien VERIFI und CLARITI zeigten eine konsistente Genauigkeit in verschiedenen Hochrisikogruppen, einschließlich Personen mit familiärer Vorgeschichte, genetischen Mutationen, Diabetes und Bauchspeicheldrüsenzysten.
Das Unternehmen plant, den Test im dritten Quartal 2025 kommerziell einzuführen, mit weiteren klinischen Studien, die im Laufe des Jahres zur Unterstützung von regulatorischen Einreichungen und Erstattungsbemühungen der Kostenträger geplant sind. Immunovia sucht auch kommerzielle Partner, um die Markteinführung zu beschleunigen.
- Test achieved 77% sensitivity in detecting early-stage pancreatic cancer, surpassing 65% target
- Outperformed existing CA19-9 biomarker (69% sensitivity)
- Demonstrated consistent accuracy across multiple high-risk patient groups
- Commercial launch planned for Q3 2025
- 88% specificity fell short of 90% target
- control sample size (271) affected specificity precision
- Additional clinical studies still required for regulatory approval
Insights
Immunovia's latest VERIFI study results represent a significant clinical milestone with promising commercial implications. The next-generation pancreatic cancer test demonstrated 77% sensitivity for early-stage pancreatic cancer detection, substantially exceeding the
This performance differential creates a compelling value proposition for market adoption, particularly within the high-risk patient segments where early detection dramatically impacts survival rates. The consistent performance across diverse high-risk groups (those with family history, genetic mutations, diabetes, and pancreatic cysts) meaningfully expands Immunovia's addressable market beyond what was previously validated.
The Q3 2025 commercial launch timeline provides a clear catalyst for near-term value creation. However, investors should recognize that additional clinical studies, regulatory submissions, and payer reimbursement negotiations represent critical execution milestones before revenue materialization. The company's engagement with commercial partners signals strategic recognition that distribution partnerships may accelerate market penetration and potentially improve capital efficiency.
While specificity at
The VERIFI study results demonstrate meaningful clinical progress in pancreatic cancer diagnostics. Detecting
The consistent performance across diverse high-risk populations is particularly noteworthy. Current screening protocols struggle with heterogeneous risk factors, so a single test showing robust detection across familial risk, genetic mutation carriers, diabetic patients, and those with pancreatic cysts addresses a critical clinical need. The
The test's potential clinical utility depends on its integration into screening protocols for high-risk individuals. Immunovia's planned additional studies will be crucial for determining optimal testing intervals and clinical decision pathways. The Q3 2025 commercial timeline appears realistic given the completed validation studies, though regulatory review processes could present timing risks.
For a screening test targeting asymptomatic high-risk individuals, the sensitivity/specificity balance demonstrated in these studies represents a meaningful advancement over current capabilities, potentially enabling the shift toward earlier detection where surgical intervention remains the only curative option for pancreatic cancer.
Immunovia's next-generation test detected significantly more cancers than CA19-9, a common biomarker for pancreatic cancer, in the study. The company also announced that the specificity of its test in the VERIFI study was equivalent to CA19-9 and just below the target specificity for the trial.
"The Immunovia test accurately classified cancerous and non-cancerous blood samples in the VERIFI study," said Jeff Borcherding, CEO of Immunovia. "The test once again significantly outperformed CA19-9. In addition, combined results from the CLARITI and VERIFI studies make it clear that our next-generation test can accurately detect pancreatic cancer in multiple different groups of high-risk individuals."
VERIFI met the primary study endpoint. On March 19 2025, Immunovia announced the VERIFI study met its primary endpoint, with the test successfully detecting
Combined data showed strong accuracy across multiple high-risk patient groups. Combined data from the VERIFI and CLARITI validation studies allow for robust analysis of test performance across patient groups at high risk for different reasons. The Immunovia next-generation test demonstrated excellent and consistent sensitivity and specificity across key high-risk groups, including those at risk due to family history of pancreatic cancer or genetic mutations, patients with diabetes, and people with pancreatic cysts:
Risk Group
|
Cases
|
Controls
|
Sensitivity
|
Specificity
|
Overall
|
317
|
1,134
|
78 %
|
92 %
|
Familial/Genetic
|
71
|
922
|
78 %
|
94 %
|
Diabetes
|
128
|
105
|
80 %
|
90 %
|
Cysts
|
79
|
426
|
72 %
|
89 %
|
"The combined test performance data from CLARIFI and VERIFI represents a key milestone for Immunovia: demonstrating excellent test accuracy across multiple groups of high-risk patient groups for the first time," said Jeff Borcherding, CEO of Immunovia. "These data bolster our commercial opportunity and expand our addressable market."
Specificity in the VERIFI study was in line with target performance and CA19-9. The specificity of the Immunovia test was
VERIFI results strengthen and support Immunovia's commercial plans. Immunovia is actively preparing to launch its next-generation test in the third quarter of 2025. The company will conduct additional clinical studies throughout the year to assess the test's clinical impact and further evaluate its accuracy in other high-risk populations. These studies will support regulatory submissions and payer reimbursement efforts. Immunovia is also engaging potential commercial partners to accelerate market adoption.
About the VERIFI Study
The VERIFI study was conducted using 385 blood samples from six leading pancreatic cancer centers in the
About Pancreatic Cancer
Pancreatic cancer is one of the most aggressive cancers, with a five-year survival rate of just
For more information, please contact:
Jeff Borcherding
CEO and President
jeff.borcherding@immunovia.com
Immunovia in brief
Immunovia AB (IMMNOV: Nasdaq Stockholm), is a diagnostic company whose mission is to increase survival rates for patients with pancreatic cancer through early detection. Immunovia is focused on the development and commercialization of simple blood-based testing to detect proteins and antibodies that indicate a high-risk individual has developed pancreatic cancer.
Immunovia collaborates and engages with healthcare providers, leading experts and patient advocacy groups to make its test available to individuals at increased risk for pancreatic cancer.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com
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