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Immunovia has successfully acquired all blood samples required to clinically validate its next-generation test for pancreatic cancer

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Immunovia (IMMNOV: Nasdaq Stockholm) has successfully acquired all blood samples needed to clinically validate its next-generation test for pancreatic cancer. The company has secured over 1,000 blood samples, including 200+ from early-stage pancreatic cancer patients and 800+ from high-risk individuals without cancer. This marks a key milestone towards completing one of the largest clinical validation studies of a pancreatic cancer biomarker test to date.

The study aims to confirm the sensitivity and specificity of Immunovia's new test in differentiating early-stage pancreatic cancer samples from those without cancer. Collaborators include researchers from the University of Pittsburgh, Oregon Health and Science University, University of Verona, and the Pancreatic Cancer Early Detection (PRECEDE) Consortium. Immunovia expects to complete the study in December 2024 and launch the test later in 2025.

Immunovia (IMMNOV: Nasdaq Stockholm) ha acquisito con successo tutti i campioni di sangue necessari per convalidare clinicamente il suo test di nuova generazione per il cancro pancreatico. L'azienda ha ottenuto oltre 1.000 campioni di sangue, di cui più di 200 da pazienti con cancro pancreatico in fase iniziale e oltre 800 da individui ad alto rischio senza cancro. Questo rappresenta una tappa fondamentale verso il completamento di uno dei più grandi studi di validazione clinica di un test biomarker per il cancro pancreatico fino ad oggi.

Lo studio mira a confermare la sensibilità e la specificità del nuovo test di Immunovia nel differenziare i campioni di cancro pancreatico in fase iniziale da quelli senza cancro. I collaboratori includono ricercatori dell'Università di Pittsburgh, dell'Oregon Health and Science University, dell'Università di Verona e del Consorzio per la Rilevazione Precoce del Cancro Pancreatico (PRECEDE). Immunovia prevede di completare lo studio a dicembre 2024 e lanciare il test entro la fine del 2025.

Immunovia (IMMNOV: Nasdaq Stockholm) ha adquirido con éxito todas las muestras de sangre necesarias para validar clínicamente su prueba de nueva generación para el cáncer de páncreas. La empresa ha obtenido más de 1,000 muestras de sangre, incluyendo más de 200 de pacientes con cáncer de páncreas en etapa temprana y más de 800 de individuos de alto riesgo sin cáncer. Esto marca un hito clave hacia la finalización de uno de los estudios de validación clínica más grandes de un test biomarcador para el cáncer de páncreas hasta la fecha.

El estudio tiene como objetivo confirmar la sensibilidad y especificidad de la nueva prueba de Immunovia para diferenciar las muestras de cáncer de páncreas en etapa temprana de aquellas sin cáncer. Los colaboradores incluyen investigadores de la Universidad de Pittsburgh, la Universidad de Ciencias y Salud de Oregón, la Universidad de Verona y el Consorcio de Detección Temprana de Cáncer de Páncreas (PRECEDE). Immunovia espera completar el estudio en diciembre de 2024 y lanzar la prueba a finales de 2025.

Immunovia (IMMNOV: 나스닥 스톡홀름)은 모든 혈액 샘플을 성공적으로 확보했습니다, 췌장암을 위한 차세대 테스트를 임상적으로 검증하는 데 필요한. 이 회사는 1,000개 이상의 혈액 샘플을 확보했으며, 이 중 200개 이상은 초기 췌장암 환자로부터, 800개 이상은 암이 없는 고위험 개인으로부터 나왔습니다. 이는 현재까지 췌장암 바이오마커 테스트의 가장 큰 임상 검증 연구 중 하나를 완료하기 위한 중요한 이정표입니다.

이 연구는 Immunovia의 새로운 테스트가 초기 췌장암 샘플과 비암 샘플을 구별하는 민감도와 특이성을 확인하는 것을 목표로 합니다. 공동 연구자에는 피츠버그 대학교, 오리건 보건 과학 대학교, 베로나 대학교 및 췌장암 조기 발견(PRECEDE) 컨소시엄의 연구자들이 포함됩니다. Immunovia는 2024년 12월에 연구를 완료할 것으로 예상하고 2025년 말에 테스트를 출시할 예정입니다.

Immunovia (IMMNOV: Nasdaq Stockholm) a réussi à acquérir tous les échantillons de sang nécessaires pour valider cliniquement son test de nouvelle génération pour le cancer du pancréas. L'entreprise a sécurisé plus de 1 000 échantillons de sang, dont plus de 200 provenant de patients atteints de cancer du pancréas à un stade précoce et plus de 800 provenant d'individus à risque élevé sans cancer. Cela marque une étape clé vers l'achèvement de l'une des plus grandes études de validation clinique d'un test de biomarqueur du cancer du pancréas à ce jour.

L'étude vise à confirmer la sensibilité et la spécificité du nouveau test d'Immunovia pour différencier les échantillons de cancer du pancréas à un stade précoce de ceux sans cancer. Les collaborateurs incluent des chercheurs de l'Université de Pittsburgh, de l'Oregon Health and Science University, de l'Université de Vérone, et du Consortium pour la Détection Précoce du Cancer du Pancréas (PRECEDE). Immunovia prévoit de compléter l'étude en décembre 2024 et de lancer le test plus tard en 2025.

Immunovia (IMMNOV: Nasdaq Stockholm) hat erfolgreich alle benötigten Blutproben erworben, um seinen Neuartigen Test auf Bauchspeicheldrüsenkrebs klinisch zu validieren. Das Unternehmen hat über 1.000 Blutproben gesichert, darunter mehr als 200 von Patienten mit Bauchspeicheldrüsenkrebs im Frühstadium und über 800 von Hochrisikopersonen ohne Krebs. Dies stellt einen wichtigen Meilenstein auf dem Weg zur Vollendung einer der größten klinischen Validierungsstudien eines Biomarkertests für Bauchspeicheldrüsenkrebs bis heute dar.

Die Studie zielt darauf ab, die Sensitivität und Spezifität des neuen Tests von Immunovia zu bestätigen, um Proben von Bauchspeicheldrüsenkrebs im Frühstadium von jenen ohne Krebs zu differenzieren. Zu den Kollaborateuren gehören Forscher von der Universität Pittsburgh, der Oregon Health and Science University, der Universität Verona und dem Pancreatic Cancer Early Detection (PRECEDE) Konsortium. Immunovia erwartet, die Studie im Dezember 2024 abzuschließen und den Test später im Jahr 2025 zu lancieren.

Positive
  • Successfully acquired over 1,000 blood samples for clinical validation study
  • Collaboration with prestigious research institutions and PRECEDE Consortium
  • On track to complete clinical validation study by December 2024
  • Planned launch of next-generation pancreatic cancer detection test in 2025
  • Potential to improve early detection of pancreatic cancer in high-risk individuals
Negative
  • None.

LUND, Sweden, Oct. 7, 2024 /PRNewswire/ -- Immunovia (IMMNOV: Nasdaq Stockholm), the pancreatic cancer diagnostics company, today announces that the company has acquired all blood samples required to clinically validate its next-generation test for pancreatic cancer. Concluding the sample collection effort marks a key milestone toward successfully completing the clinical validation study. 

The study seeks to confirm the sensitivity and specificity reported previously in the company's model-development study of its new test. The trial will be a case-control study evaluating the accuracy of the next-generation test in differentiating blood samples from people with early-stage pancreatic cancer from individuals without it. 

Immunovia has secured over 1,000 blood samples, including over 200 from patients with stage 1 and 2 pancreatic cancer and more than 800 blood samples from high-risk individuals without cancer. The study will be one of the largest clinical validation studies of a pancreatic cancer biomarker test conducted to date. 

Immunovia leveraged long-standing relationships with researchers at pancreatic cancer centers in Europe and North America to acquire the blood samples. Key collaborators who contributed an especially large number of samples included Dr. Randall Brand, University of Pittsburgh Department of Medicine; Dr. Rosie Sears, Oregon Health and Science University; and Dr. Salvatore Paiella, University of Verona. 

This study marks Immunovia's first research collaboration with the Pancreatic Cancer Early Detection (PRECEDE) Consortium. The PRECEDE Consortium, led by Dr. Diane Simeone, is an international, multi-institutional collaborative group of experts working to improve early detection of pancreatic cancer through a novel model of collaboration and data sharing. The PRECEDE Consortium provided nearly 500 samples from its ongoing study of people at high-risk for hereditary cancer. 

"We are excited to announce that we have secured all samples required to clinically validate our next-generation test. This study represents a pivotal step in our mission to bring early detection of pancreatic cancer to high-risk individuals," says Jeff Borcherding, CEO and President of Immunovia.

As communicated previously, Immunovia expects to complete the clinical validation study in December 2024 in preparation for launching its next-generation test for early detection of pancreatic cancer later in 2025.

For more information, please contact:
Jeff Borcherding 
CEO and President 
jeff.borcherding@immunovia.com  
Karin Almqvist Liwendahl
Chief Financial Officer
karin.almqvist.liwendahl@immunovia.com 
+46 709 11 56 08

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. 

USA is the world's largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing. 

Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visitwww.immunovia.com 

This information was brought to you by Cision http://news.cision.com.

https://news.cision.com/immunovia-ab/r/immunovia-has-successfully-acquired-all-blood-samples-required-to-clinically-validate-its-next-gener,c4047677

The following files are available for download:

https://mb.cision.com/Main/13121/4047677/3040639.pdf

Press release (PDF)

 

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SOURCE Immunovia AB

FAQ

What is the purpose of Immunovia's clinical validation study for its pancreatic cancer test?

The study aims to confirm the sensitivity and specificity of Immunovia's next-generation test in differentiating blood samples from people with early-stage pancreatic cancer from individuals without it.

How many blood samples has Immunovia (IMMNOV) acquired for its pancreatic cancer test validation?

Immunovia has secured over 1,000 blood samples, including over 200 from patients with stage 1 and 2 pancreatic cancer and more than 800 from high-risk individuals without cancer.

When does Immunovia (IMMNOV) expect to complete its clinical validation study?

Immunovia expects to complete the clinical validation study in December 2024.

What is the target launch date for Immunovia's next-generation pancreatic cancer detection test?

Immunovia plans to launch its next-generation test for early detection of pancreatic cancer later in 2025.

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