Immunovia completes development of its pancreatic cancer detection test after substantially increasing test accuracy

Rhea-AI Summary

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.

Positive

• 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

Negative

• None.

Insights

Medical Research Analyst

The completion of Immunovia's next-generation pancreatic cancer detection test marks a significant milestone in early cancer diagnostics. With a sensitivity of 85% and specificity of 98% for stage 1 and 2 pancreatic ductal adenocarcinomas (PDAC), this test represents a substantial improvement over existing methods.

Particularly noteworthy is the test's performance in patients aged 65 and older, achieving 91% sensitivity and 98% specificity. This is important given that the average age of PDAC diagnosis is around 70 years. The test's ability to outperform CA19-9, a common pancreatic cancer biomarker, by 20 percentage points is also remarkable.

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.

Financial Analyst

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 $500, the total addressable market could exceed $900 million annually in the U.S. alone.

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.

Oncology Doctor

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 85% sensitivity and 98% specificity for early-stage PDAC are impressive figures that could significantly improve our ability to detect pancreatic cancer at a curable stage.

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.

LUND, Sweden, Aug. 1, 2024 /PRNewswire/ -- Immunovia (Nasdaq Stockholm: IMMNOV), the pancreatic cancer diagnostics company, today announces enhanced performance for its next-generation test for detecting stage 1 and 2 pancreatic ductal adenocarcinomas (PDAC) in high-risk individuals, which are potentially curable with surgery and modern treatments.

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 85% with a specificity of 98% in detecting stage 1 and 2 PDAC.

A sensitivity of 85% means the new test is capable of detecting pancreatic cancer in approximately 6 out of every 7 people with early-stage disease. Specificity of 98% means this new test should return a false positive result just once for every 50 people tested who do not have pancreatic cancer. Test performance was refined by leveraging additional samples with more complete and detailed clinical information and through more sophisticated statistical modeling. Test performance was independently confirmed by ACOMED, a statistical analysis firm with deep expertise in diagnostic studies.

In this study, Immunovia's next-generation test outperformed the sensitivity of CA19-9, a commonly used pancreatic cancer biomarker, by 20 percentage points (85% vs 65%, respectively, p<0.001).

In 294 patients aged 65 years and older, the next-generation test achieved 91% sensitivity and 98% specificity. Results in this group are particularly important since the average age of PDAC diagnosis is near 70 years.

"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 U.S. in 2025."

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 the United States 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 visit www.immunovia.com

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

https://news.cision.com/immunovia-ab/r/immunovia-completes-development-of-its-pancreatic-cancer-detection-test-after-substantially-increasi,c4020360

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Press release (PDF)

 

View original content:https://www.prnewswire.com/news-releases/immunovia-completes-development-of-its-pancreatic-cancer-detection-test-after-substantially-increasing-test-accuracy-302212109.html

SOURCE Immunovia AB

FAQ

What is the sensitivity and specificity of Immunovia's new pancreatic cancer detection test?

Immunovia's next-generation test for detecting stage 1 and 2 pancreatic ductal adenocarcinomas (PDAC) has achieved 85% sensitivity and 98% specificity.

How does Immunovia's test compare to the CA19-9 biomarker for pancreatic cancer detection?

Immunovia's next-generation test outperformed the sensitivity of CA19-9, a commonly used pancreatic cancer biomarker, by 20 percentage points (85% vs 65%, respectively).

When does Immunovia (IMMNOV) plan to launch its pancreatic cancer detection test in the United States?

Immunovia plans to launch its next-generation pancreatic cancer detection test in the United States in 2025.

How many samples were used in Immunovia's model development study for the pancreatic cancer test?

The model development study included 624 patient samples from 13 different clinical sites, with 129 samples from patients with stage 1 or 2 PDAC and 495 control samples.