Immunovia announces another successful clinical validation of its next-generation pancreatic cancer test
Immunovia (IMMNOV: Nasdaq Stockholm) has announced positive results from the VERIFI study, their second clinical validation study of their next-generation pancreatic cancer test. The test successfully achieved its primary endpoint by detecting 77% of stage I and II pancreatic cancer cases.
Dr. Patricio Polanco from the Harold C. Simmons Comprehensive Cancer Center highlighted the test's high accuracy in detecting early-stage PDAC in high-risk patients. CEO Jeff Borcherding emphasized that this second successful validation will support insurance reimbursement efforts.
The company plans to launch the next-generation test in Q3 2025. Additional clinical studies are planned throughout the year to evaluate clinical impact and accuracy in other high-risk populations, supporting regulatory submissions and payer reimbursement. Immunovia is also seeking commercial partners to accelerate market adoption.
Immunovia (IMMNOV: Nasdaq Stockholm) ha annunciato risultati positivi dallo studio VERIFI, il loro secondo studio di validazione clinica per il test di nuova generazione sul cancro pancreatico. Il test ha raggiunto con successo il suo obiettivo primario, rilevando il 77% dei casi di cancro pancreatico di stadio I e II.
Il Dr. Patricio Polanco del Harold C. Simmons Comprehensive Cancer Center ha evidenziato l'alta precisione del test nel rilevare il PDAC in fase iniziale nei pazienti ad alto rischio. Il CEO Jeff Borcherding ha sottolineato che questa seconda validazione di successo supporterà gli sforzi per il rimborso assicurativo.
L'azienda prevede di lanciare il test di nuova generazione nel terzo trimestre del 2025. Sono previsti ulteriori studi clinici nel corso dell'anno per valutare l'impatto clinico e l'accuratezza in altre popolazioni ad alto rischio, supportando le sottomissioni normative e il rimborso da parte dei pagatori. Immunovia sta anche cercando partner commerciali per accelerare l'adozione sul mercato.
Immunovia (IMMNOV: Nasdaq Stockholm) ha anunciado resultados positivos del estudio VERIFI, su segundo estudio de validación clínica para su prueba de cáncer pancreático de nueva generación. La prueba logró con éxito su objetivo primario al detectar el 77% de los casos de cáncer pancreático en estadio I y II.
El Dr. Patricio Polanco del Harold C. Simmons Comprehensive Cancer Center destacó la alta precisión de la prueba para detectar PDAC en etapas tempranas en pacientes de alto riesgo. El CEO Jeff Borcherding enfatizó que esta segunda validación exitosa apoyará los esfuerzos de reembolso de seguros.
La compañía planea lanzar la prueba de nueva generación en el tercer trimestre de 2025. Se planean estudios clínicos adicionales a lo largo del año para evaluar el impacto clínico y la precisión en otras poblaciones de alto riesgo, apoyando las presentaciones regulatorias y el reembolso de los pagadores. Immunovia también está buscando socios comerciales para acelerar la adopción en el mercado.
Immunovia (IMMNOV: 나스닥 스톡홀름)은 차세대 췌장암 검사에 대한 두 번째 임상 검증 연구인 VERIFI 연구의 긍정적인 결과를 발표했습니다. 이 검사는 1기 및 2기 췌장암 사례의 77%를 성공적으로 탐지하여 주요 목표를 달성했습니다.
해롤드 C. 시먼스 종합 암 센터의 파트리시오 폴란코 박사는 고위험 환자에서 초기 단계 PDAC를 탐지하는 데 있어 검사의 높은 정확성을 강조했습니다. CEO 제프 보르처딩은 이 두 번째 성공적인 검증이 보험 환급 노력을 지원할 것이라고 강조했습니다.
회사는 2025년 3분기에 차세대 검사를 출시할 계획입니다. 올해 동안 임상적 영향과 정확성을 평가하기 위한 추가 임상 연구가 계획되어 있으며, 이는 규제 제출 및 지불자 환급을 지원합니다. Immunovia는 또한 시장 채택을 가속화하기 위해 상업적 파트너를 찾고 있습니다.
Immunovia (IMMNOV: Nasdaq Stockholm) a annoncé des résultats positifs de l'étude VERIFI, sa deuxième étude de validation clinique pour son test de cancer du pancréas de nouvelle génération. Le test a réussi à atteindre son objectif principal en détectant 77% des cas de cancer du pancréas de stade I et II.
Le Dr Patricio Polanco du Harold C. Simmons Comprehensive Cancer Center a souligné la haute précision du test dans la détection du PDAC à un stade précoce chez les patients à haut risque. Le PDG Jeff Borcherding a souligné que cette deuxième validation réussie soutiendra les efforts de remboursement des assurances.
L'entreprise prévoit de lancer le test de nouvelle génération au troisième trimestre 2025. D'autres études cliniques sont prévues tout au long de l'année pour évaluer l'impact clinique et la précision dans d'autres populations à haut risque, soutenant les soumissions réglementaires et le remboursement par les payeurs. Immunovia recherche également des partenaires commerciaux pour accélérer l'adoption sur le marché.
Immunovia (IMMNOV: Nasdaq Stockholm) hat positive Ergebnisse aus der VERIFI-Studie bekannt gegeben, ihrer zweiten klinischen Validierungsstudie für den Test auf Bauchspeicheldrüsenkrebs der nächsten Generation. Der Test hat erfolgreich sein primäres Ziel erreicht, indem er 77% der Fälle von Bauchspeicheldrüsenkrebs im Stadium I und II nachgewiesen hat.
Dr. Patricio Polanco vom Harold C. Simmons Comprehensive Cancer Center hob die hohe Genauigkeit des Tests bei der Erkennung von PDAC im Frühstadium bei Hochrisikopatienten hervor. CEO Jeff Borcherding betonte, dass diese zweite erfolgreiche Validierung die Bemühungen um die Erstattung durch Versicherungen unterstützen wird.
Das Unternehmen plant, den Test der nächsten Generation im dritten Quartal 2025 auf den Markt zu bringen. Weitere klinische Studien sind im Laufe des Jahres geplant, um die klinischen Auswirkungen und die Genauigkeit in anderen Hochrisikopopulationen zu bewerten, um regulatorische Einreichungen und die Erstattung durch Kostenträger zu unterstützen. Immunovia sucht auch nach kommerziellen Partnern, um die Markteinführung zu beschleunigen.
- 77% detection rate for early-stage (I and II) pancreatic cancer
- Second successful clinical validation strengthens reimbursement potential
- Clear commercialization timeline with Q3 2025 launch
- Additional clinical studies still required for regulatory approval
- Commercial partnerships not yet secured
- Insurance reimbursement pending
"The high accuracy of the Immunovia test in detecting stage I and II PDAC in a second independent clinical population of high-risk patients is very encouraging," said Dr. Patricio Polanco, Co-Director of the Pancreatic Cancer Program and the Pancreatic Cancer Prevention Clinic at the Harold C. Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center. "Additional biomarkers to support the diagnosis of patients with early-stage disease are critical for improving long-term oncologic outcomes in pancreatic cancer."
"We are excited to see additional proof of the accuracy of our next-generation test," said Jeff Borcherding, CEO of Immunovia. "Completing a second successful clinical validation study will strengthen our efforts to secure insurance reimbursement for the test. We look forward to sharing additional data and analysis from the VERIFI study in upcoming scientific meetings and publications."
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 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 further information, please contact
Jeff Borcherding, CEO
jeff.borcherding@immunovia.com
The information in this report is information that Immunovia AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 13:15 am CET on March 19, 2025.
Immunovia in brief
Immunovia AB 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.
For more information, please visit www.immunovia.com.
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SOURCE Immunovia AB
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