TEST:

IMMray™ PanCan-d

"Immunovia...today announces its next-generation pancreatic cancer test achieved both the primary and secondary endpoints in a model-development study. In the study, Immunovia's next-generation test demonstrated specificity of 98 percent and sensitivity of 75 percent in detecting early stage (1 and 2) pancreatic ductal adenocarcinoma (PDAC), a very aggressive and the most common form of pancreatic cancer. The Immunovia test was also significantly more accurate than CA19-9, the biomarker commonly used to detect pancreatic cancer....In the fourth quarter of 2024, the company will conduct a large clinical validation study to confirm the performance of the next-generation test, setting the stage for a U.S. launch in 2025."

In clinical practice, IMMray PanCan-d has a robust NPV; however, PPV is dramatically influenced by whether borderline results are characterized as a positive or negative result.

"Immunovia...announced plans to restructure its operations. The company will cease commercialization of its IMMray PanCan-d test in the United States to focus its resources on the further development and clinical testing of the Company’s promising next generation pancreatic cancer detection test...Immunovia expects to release further details about the next-generation test later this year, with an anticipated launch date in 2024."

"Immunovia...announced it will host an event to discuss the adoption of IMMrayTM PanCan-d test key opinion leaders on May 3, 2023, at 16:00 pm CET (10:00 am ET)...Immunovia Management will also discuss its commercialization strategy for IMMrayTM PanCan-d test in the U.S."

The clinical implementation of IMMray PanCan-d in asymptomatic high-risk surveillance populations showed results similar to those obtained in test validation, but a higher percentage of positive test results was obtained due to test utilization in the work-up of suspicious mass lesions of the pancreas.

"Immunovia...announced it is realigning its Swedish operations with its strategic priorities to drive R&D productivity and focus on the US commercialization of the IMMray™ PanCan-d test....Immunovia has initiated a consultation process with relevant Swedish unions to create the best possible transition for the affected employees. The Company will provide an update once the consultation process is concluded."

"Immunovia...announced that the Centers for Medicare and Medicaid Services (CMS) has finalized their payment determination on a price of $897 for Immunovia’s IMMray PanCan-d test. The determined rate will be effective from 1st January 2023."

One-third of subjects that participated in the study have presumptive IPMNs. IMMray PanCan-d test classification (positive vs negative) is not significantly impacted by IPMN size although more subtle changes in decision values can be detected as a function of cyst size. These differences appear to result from differences in the contribution of the 8-protein biomarkers in samples for cysts >3.0 cm.

"Immunovia AB...announced that it enters into a strategic partnership with Proteomedix to leverage its substantial joint development experience in diagnostic technologies for the detection of cancer. This will enable increased R&D productivity for Immunovia as the Company continues to strengthen its commercial development in the US...The partnership capitalizes on the combined expertise of two leading innovators in proteomics-based diagnostics, who have both launched innovative oncology tests, Immunovia with IMMray™ PanCan-d in the U.S. and Proteomedix with Proclarix® in Europe."

"Immunovia AB...announced positive feedback from its physician experience program for the IMMray™ PanCan-d test in the U.S., which is nearing completion. The program has included 23 high risk surveillance centers around the U.S. thus far, and physicians have showed substantial interest in the use of IMMray™ PanCan-d to detect early-stage pancreatic cancer."

"Immunovia AB...announced, that the Centers for Medicare & Medicaid Services (CMS) published a preliminary payment determination implying a price of $897 for the IMMray PanCan-d test...CMS agreed with the recommendation made by the Clinical Diagnostic Laboratory Tests (CDLT) Advisory Panel to crosswalk IMMray PanCan-d rate to code 81503, brand name OVA1, which currently has a price of $897. After a period of public comment, CMS will finalize its basis for payment decision in November."

"The California Department of Public Health has granted Immunovia, Inc., the American subsidiary of Immunovia AB, a Clinical and Public Health Laboratory license, allowing physicians in California to order the IMMray PanCan-d test for their patients."

"Immunovia AB...announced, that Immunovia, Inc., its American subsidiary, has recently received approval for a Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code from the American Medical Association (AMA) for the IMMray™ PanCan-d test."

"Immunovia today announced results from the PanFAM-1 study. The PanFAM-1 study is a prospective, multi-center, investigational study, designed to assess the performance of the IMMray™ PanCan-d test in early detection of pancreatic ductal adenocarcinoma (PDAC) in high-risk populations. The IMMray™ PanCan-d test met its primary endpoint of test specificity comparable to imaging in the study. Sensitivity, however, could not be evaluated due to the low number of PDACs among study participants."

"The Pennsylvania and Maryland Departments of Health have granted Immunovia, Inc., the US subsidiary of Immunovia AB...Clinical Laboratory permits, allowing physicians in Pennsylvania and Maryland to order the IMMray™ PanCan-d test for their patients."

"The Rhode Island Department of Health has granted Immunovia, Inc., the US subsidiary of Immunovia AB...Clinical Laboratory licensure, allowing physicians in Rhode Island to order the IMMray™ PanCan-d test for their patients."

The commercial availability of a biomarker assay for the early detection of PDAC resulted in a testing population with demographics and referral criteria similar to that of PDAC high-risk surveillance programs in the U.S. IMMray PanCan-d test results were as expected based on prior validation studies.

"Immunovia, Inc., the American subsidiary of Immunovia AB...has submitted an application for a Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code to the American Medical Association (AMA) for the IMMray PanCan-d test...A PLA code for IMMray PanCan-d would allow health care professionals to specifically identify IMMray PanCan-d when submitting information and claims to health insurances and payers."

P=N/A; Active, not recruiting --> Completed | N=2000 --> 1349

"The Accreditation Committee of the College of American Pathologists (CAP) has awarded accreditation to Immunovia, Inc. in Marlborough, Massachusetts, based on the positive results of a recent onsite inspection as part of the CAP’s Accreditation Programs...allows us to seek licensure in the 5 remaining US states, allowing us to roll out the IMMray™ PanCan-d test to individuals in all 50 states, including California and New York, in the near future, further advancing our mission to make early detection of pancreatic cancer broadly available.'"

"Immunovia AB (publ) announced...that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for the patent application for the IMMray™ PanCan-d test available exclusively from Immunovia, Inc. This means that the Immunovia IMMray™ PanCan-d test signature will be further covered by the resultant patent once it is issued."

"Immunovia AB (publ) announces that the peer-reviewed, blinded study to independently validate the clinical performance of IMMray™ PanCan-d has been published in Clinical and Translational Gastroenterology. The article is available online on the journal’s website...The results demonstrate that the IMMray™ PanCan-d blood test can detect pancreatic ductal adenocarcinoma (PDAC) with high specificity (99%) and high sensitivity (89%) in stage I/II when excluding individuals with low levels of CA19-9."

Test results were automatically generated, using validated custom software with a locked algorithm and predefined decision value cutoffs for sample classification.ResultsThe IMMray PanCan-d test distinguished PDAC stages I & II (n=56) vs high-risk individuals with 98% specificity and 85% sensitivity, and distinguished PDAC stages I - IV vs high-risk individuals with 98% specificity and 87% sensitivity.We identified samples with a CA19-9 value of 2.5 U/ml or less as probable Lewis null (le/le) individuals. Excluding these 55 samples from the analysis increased the IMMray PanCan-d test sensitivity to 92% for PDAC stages I-IV (n=157) vs controls (n=379) while maintaining specificity at 99%; test sensitivity for PDAC stages I & II increased from 85% to 89%.ConclusionThese results demonstrate the IMMray PanCan-d blood test can detect PDAC with high specificity (99%) and sensitivity (92%).

"Immunovia AB...announced that Thomas King, MD, PhD, Medical Director of Immunovia, Inc. was awarded the Presidential Poster Award at the American College of Gastroenterology (ACG) Annual Scientific Meeting for the pivotal blind validation results for the IMMray™ PanCan-d test...The abstract reports the results of Immunovia, Inc.’s blind validation study, demonstrating that the IMMray™ PanCan-d test can identify stage I & II pancreatic ductal adenocarcinoma (PDAC) with 89% sensitivity and 99% specificity."

The IMMray PanCan-d test was able to distinguish PDAC stages I & II (n=56) vs high-risk individuals with 98% specificity and 85% sensitivity and distinguished PDAC stages I – IV vs high-risk individuals with 98% specificity and 87% sensitivity. Very similar results were demonstrated in PDAC vs healthy controls, with 99% specificity and 85% sensitivity in detecting stage I & II PDAC. Based on available research, we identified samples with a CA19-9 value of 2.5 U/ml or less as probable Lewis null (le/le) individuals.

P=N/A; Trial completion date: Jun 2022 --> Sep 2021 | Trial primary completion date: Apr 2021 --> Sep 2021

P=N/A; N=2000; Active, not recruiting; Sponsor: Immunovia, Inc.; Recruiting --> Active, not recruiting; Trial primary completion date: Oct 2020 --> Apr 2021