Immunovia completes development of its pancreatic cancer detection test after substantially increasing test accuracy
Immunovia (IMMNOV) has completed development of its next-generation pancreatic cancer detection test, achieving 85% sensitivity and 98% specificity in detecting stage 1 and 2 pancreatic ductal adenocarcinomas (PDAC). The test outperformed CA19-9, a common pancreatic cancer biomarker, by 20 percentage points. In patients aged 65 and older, the test achieved 91% sensitivity and 98% specificity. The study included 624 patient samples from 13 clinical sites. Immunovia plans to launch the test in the U.S. in 2025, following a large, independent clinical validation study in Q4 2024. The company estimates that 1.8 million high-risk individuals in the USA could benefit from annual surveillance testing.
Immunovia (IMMNOV) ha completato lo sviluppo del suo test di rilevamento del cancro al pancreas di nuova generazione, raggiungendo 85% di sensibilità e 98% di specificità nel rilevamento di adenocarcinomi duttali pancreatici (PDAC) di stadio 1 e 2. Il test ha superato il CA19-9, un comune biomarker per il cancro al pancreas, di 20 punti percentuali. Nei pazienti di età pari o superiore a 65 anni, il test ha ottenuto 91% di sensibilità e 98% di specificità. Lo studio ha incluso 624 campioni di pazienti provenienti da 13 siti clinici. Immunovia prevede di lanciare il test negli USA nel 2025, dopo uno studio di validazione clinica indipendente di ampia portata nel quarto trimestre del 2024. L'azienda stima che 1,8 milioni di individui ad alto rischio negli Stati Uniti potrebbero beneficiare di test di sorveglianza annuali.
Immunovia (IMMNOV) ha completado el desarrollo de su prueba de detección de cáncer de páncreas de próxima generación, logrando una sensibilidad del 85% y una especificidad del 98% en la detección de adenocarcinomas ductales pancreáticos (PDAC) en etapas 1 y 2. La prueba superó al CA19-9, un biomarcador común del cáncer de páncreas, en 20 puntos porcentuales. En los pacientes de 65 años o más, la prueba alcanzó una sensibilidad del 91% y una especificidad del 98%. El estudio incluyó 624 muestras de pacientes de 13 sitios clínicos. Immunovia planea lanzar la prueba en EE. UU. en 2025, tras un gran estudio de validación clínica independiente en el cuarto trimestre de 2024. La empresa estima que 1.8 millones de personas de alto riesgo en EE. UU. podrían beneficiarse de pruebas de vigilancia anuales.
이뮤노비아 (IMMNOV)는 차세대 췌장암 검출 테스트를 개발을 완료했으며, 1단계 및 2단계 췌장관 선암(PDAC) 검출에서 85%의 민감도와 98%의 특이도를 달성했습니다. 이 테스트는 일반적인 췌장암 바이오마커인 CA19-9보다 20 퍼센트 포인트 더 뛰어난 성과를 보였습니다. 65세 이상의 환자에서는 91%의 민감도와 98%의 특이도를 달성했습니다. 이 연구는 13개 임상 사이트에서 624명의 환자 샘플을 포함했습니다. 이뮤노비아는 2024년 4분기에 대규모 독립 임상 검증 연구 후 2025년 미국에서 테스트를 출시할 계획입니다. 이 회사는 미국에서 연간 감시 검사를 통해 180만 명의 고위험 개인이 혜택을 받을 수 있을 것으로 추정하고 있습니다.
Immunovia (IMMNOV) a terminé le développement de son test de détection du cancer du pancréas de nouvelle génération, atteignant une sensibilité de 85% et une spécificité de 98% dans la détection des adénocarcinomes canalaire pancreatique (PDAC) de stade 1 et 2. Le test a surpassé le CA19-9, un biomarqueur commun du cancer du pancréas, de 20 points de pourcentage. Chez les patients âgés de 65 ans et plus, le test a atteint une sensitivity de 91% et une spécificité de 98%. L'étude incluait 624 échantillons de patients provenant de 13 sites cliniques. Immunovia prévoit de lancer le test aux États-Unis en 2025, après une grande étude de validation clinique indépendante au quatrième trimestre 2024. L'entreprise estime que 1,8 million de personnes à haut risque aux États-Unis pourraient bénéficier de tests de surveillance annuels.
Immunovia (IMMNOV) hat die Entwicklung seines next-generation Tests zur Erkennung von Bauchspeicheldrüsenkrebs abgeschlossen und eine Empfindlichkeit von 85% und eine Spezifität von 98% bei der Erkennung von duktalen adenokarzinomen im Stadium 1 und 2 erzielt. Der Test übertraf CA19-9, einen häufigen Biomarker für Bauchspeicheldrüsenkrebs, um 20 Prozentpunkte. Bei Patienten ab 65 Jahren erreichte der Test 91% Empfindlichkeit und 98% Spezifität. Die Studie umfasste 624 Patientenproben aus 13 klinischen Standorten. Immunovia plant, den Test 2025 in den USA nach einer umfassenden, unabhängigen klinischen Validierungsstudie im 4. Quartal 2024 auf den Markt zu bringen. Das Unternehmen schätzt, dass 1,8 Millionen hochrisikobehaftete Personen in den USA von jährlichen Überwachungsuntersuchungen profitieren könnten.
- Improved test accuracy with 85% sensitivity and 98% specificity for early-stage pancreatic cancer detection
- Outperformed CA19-9 biomarker by 20 percentage points in sensitivity
- Achieved 91% sensitivity and 98% specificity in patients aged 65 and older
- Completed research and development efforts for the next-generation test
- Plans to launch the test in the U.S. market in 2025
- None.
The completion of Immunovia's next-generation pancreatic cancer detection test marks a significant milestone in early cancer diagnostics. With a sensitivity of
Particularly noteworthy is the test's performance in patients aged 65 and older, achieving
However, it's important to note that while these results are promising, they come from a model development study. The upcoming large, independent clinical validation study in Q4 2024 will be critical in confirming these results in a broader patient population. This step is essential for establishing the test's real-world efficacy and reliability.
If validated, this test could revolutionize pancreatic cancer surveillance, potentially leading to earlier detection and improved survival rates. The planned U.S. launch in 2025 could significantly impact the estimated 1.8 million high-risk individuals who could benefit from annual surveillance testing.
Immunovia's announcement of completing the development of its next-generation pancreatic cancer detection test is a pivotal moment for the company. This advancement positions Immunovia at the forefront of the pancreatic cancer diagnostics market, which has significant growth potential.
The U.S. market, being the largest for pancreatic cancer detection, presents a substantial opportunity. With an estimated 1.8 million high-risk individuals who could benefit from annual surveillance testing, the potential market size is considerable. Assuming a conservative annual test price of
However, investors should be cautious. The path from test development to market success is often challenging in the medical diagnostics field. Key factors to watch include:
- Results of the independent clinical validation study in Q4 2024
- Regulatory approval process
- Adoption rates among healthcare providers
- Reimbursement decisions by insurance companies
While the potential is significant, the company's ability to successfully commercialize the test and capture market share will be important for translating this scientific achievement into financial success. The planned 2025 U.S. launch will be a critical period for assessing the test's market reception and Immunovia's execution capabilities.
The development of Immunovia's next-generation pancreatic cancer detection test represents a potential game-changer in our fight against one of the most lethal cancers. The reported
Currently, pancreatic cancer is often diagnosed at advanced stages due to its subtle early symptoms and the lack of effective screening tools. This test, if validated in larger studies, could fill a critical gap in our diagnostic arsenal. The test's superior performance compared to CA19-9, especially in detecting early-stage disease, is particularly encouraging.
However, it's important to temper our enthusiasm with caution. We need to see how these results hold up in the planned independent clinical validation study. Furthermore, the test's performance in specific high-risk populations (e.g., those with hereditary risk factors or pancreatic cysts) will be important to evaluate.
If this test proves successful in real-world settings, it could potentially shift our approach to pancreatic cancer surveillance, especially in high-risk individuals. This could lead to more cases being caught at treatable stages, ultimately improving survival rates for this devastating disease.
On 22 April 2024, Immunovia announced positive results from the initial model-development study for its next-generation pancreatic cancer detection test. Subsequent efforts to increase test performance have now enhanced test accuracy, substantially improving the sensitivity of the next-generation test to
A sensitivity of
In this study, Immunovia's next-generation test outperformed the sensitivity of CA19-9, a commonly used pancreatic cancer biomarker, by 20 percentage points (
In 294 patients aged 65 years and older, the next-generation test achieved
"Results from this study serve as a promising step that a simple blood test may detect pancreatic cancer early in at-risk patients who have limited early detection options," said Randall Brand, MD, gastroenterologist, professor of medicine at the University of Pittsburgh School of Medicine, and director of the UPMC GI Malignancy Early Detection, Diagnosis and Prevention Program. Dr. Brand was an advisor on the study.
"We have now completed research and development efforts for our next-generation test and are thrilled with the accuracy of the test," said Jeff Borcherding, CEO of Immunovia. "This is a critical milestone for the company. Our next-generation test shows tremendous promise for improving pancreatic cancer surveillance with a highly accurate, convenient and affordable test. We are very optimistic about the clinical impact of the test when we launch in the
The model development study included 624 patient samples from 13 different clinical sites. 129 samples were from patients with stage 1 or 2 PDAC and 495 control samples came predominantly from people at high-risk for hereditary and/or familial pancreatic cancer, and also included people with pancreatic cysts, diabetics, and healthy individuals.
The Company will submit these results shortly for peer-reviewed publication as well as for presentation at medical conferences. A large, independent clinical validation study will be conducted in the fourth quarter of 2024 to confirm the accuracy of the Immunovia test in a larger set of patient samples. Immunovia remains on track to launch the new test in
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.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com
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FAQ
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