COMPANY:

Immunovia

"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."

"Immunovia...announces...that the company has successfully developed accurate and precise assays to measure targeted proteins for its next-generation test."

"Immunovia...announced the successful completion of the discovery phase for the Company’s next-generation test...The discovery study, which marks a key milestone in the development of Immunovia’s next-generation test to detect early-stage pancreatic cancer, successfully found more than a dozen proteins circulating in the blood that identified pancreatic ductal adenocarcinoma (PDAC) stage I and stage II patients."

"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."

"Immunovia...announced it will participate in a webinar titled 'Biomarkers and Liquid Biopsy for Early Detection of Pancreatic Cancer' hosted by the National Pancreas Foundation on April 26, 2023, at 7:00 pm ET...The webinar will address how biomarker and liquid biopsy tests are applied in clinical practice to detect cancer at early stages."

"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."

"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 the PanDIA-1 study for the early detection of pancreatic cancer in newly onset type 2 diabetics is moving into the next phase. Samples with the associated clinical data have been transferred to Immunovia from Lund University Diabetes Center (LUDC). During the second half of 2022 the samples will be analyzed as the next phase of the development plan for this large risk group."

"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."

"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."

"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."

"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."