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COMPANY:
Immunovia

i
Other names: Immunovia | Immunovia AB
Related tests:
Evidence

News

2ms
Immunovia realigning Swedish operations with strategic priorities and its focus on the US commercialization of the IMMray PanCan-d test (Immunovia Press Release)
"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."
Commercial
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IMMray™ PanCan-d
4ms
Centers for Medicare & Medicaid Services finalizes its payment determination and sets a rate of $897 for Immunovia’s IMMray PanCan-d test (Immunovia Press Release)
"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."
Pricing • Reimbursement
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IMMray™ PanCan-d
5ms
Immunovia launches a strategic partnership with Proteomedix to leverage R&D efforts with increased focus on commercialization (Immunovia Press Release)
"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."
Licensing / partnership • Commercial
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IMMray™ PanCan-d
5ms
Immunovia announces positive update on physician experience program with IMMray™ PanCan-d (Cision)
"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."
Clinical
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IMMray™ PanCan-d
6ms
Centers for Medicare & Medicaid Services issues preliminary payment rate determination for Immunovia’s IMMray PanCan-d test (Immunovia Press Release)
"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."
Reimbursement
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IMMray™ PanCan-d
7ms
Immunovia, Inc. issued Clinical and Public Health Laboratory License from California Dept of Public Health for IMMray™ PanCan-d test (Immunovia Press Release)
"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."
Regulatory
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IMMray™ PanCan-d
9ms
CPT PLA code for the IMMray™ PanCan-d test approved (Immunovia Press Release)
"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."
Reimbursement
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IMMray™ PanCan-d
9ms
The PanDIA-1 study, for early detection of pancreatic cancer in newly onset type 2 diabetics, moves into next phase (Immunovia Press Release)
"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."
Clinical
9ms
PanFAM-1 results partly inconclusive (Immunovia Press Release)
"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."
Clinical
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IMMray™ PanCan-d
10ms
Immunovia, Inc. market access increases when achieving Clinical Laboratory Permits from Pennsylvania and Maryland Departments of Health making IMMray™ PanCan-d test available in 48 US states (Immunovia Press Release)
"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."
Regulatory
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IMMray™ PanCan-d
10ms
Immunovia, Inc. achieves Clinical Laboratory Licensure from Rhode Island Dept of Health making IMMray™ PanCan-d test available in 46 US states (Immunovia Press Release)
"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."
Regulatory
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IMMray™ PanCan-d
11ms
Immunovia CPT PLA Code submission for the IMMray™ PanCan-d test is on the agenda of American Medical Association (Immunovia Press Release)
"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."
Reimbursement
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IMMray™ PanCan-d
1year
Immunovia, Inc. laboratory receives accreditation from College of American Pathologists – a major step in the nationwide US roll-out of IMMray™ PanCan-d (Immunovia Press Release)
"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.'"
Regulatory
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IMMray™ PanCan-d
1year
Immunovia further strengthens IP portfolio for its IMMray™ PanCan-d signature (Immunovia Press Release)
"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."
Patent
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IMMray™ PanCan-d
1year
IMMray™ PanCan-d – peer-reviewed, blinded validation study now published in Clinical and Translational Gastroenterology (Immunovia Press Release)
"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."
Clinical data
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IMMray™ PanCan-d
over1year
Immunovia receives Presidential Poster Award at the American College of Gastroenterology Annual Scientific Meeting (Immunovia Press Release)
"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."
Clinical data
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IMMray™ PanCan-d
over1year
Immunovia enters licensing agreement with JW BioScience for pancreatic cancer biomarkers (Immunovia Press Release)
"Immunovia AB…announced that Immunovia has strengthened its patent protection for pancreatic cancer biomarkers by obtaining a global license from the South Korean company JW BioScience's IP portfolio. The license agreement gives Immunovia global commercial rights for two biomarkers for early detection of pancreatic cancer. The biomarkers are also part of Immunovia, Inc.'s IMMray™ PanCan-d biomarker signature. Immunovia discovered these pancreatic cancer biomarkers independently of JW BioScience and have now fully secured intellectual property rights. The details and deal size of this contract are not disclosed as agreed by both parties."
Licensing / partnership
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IMMray™ PanCan-d
over1year
Immunovia provides updates on the price for the IMMray[TM] PanCan-d Test in the US and improved test performance in the familial/hereditary risk group (Immunovia Press Release)
"Immunovia announces two updates on the IMMRayTM PanCan-d test, regarding pricing and test performance...The IMMrayTM PanCan-d test is being launched at a list price of 995 USD per test, which is higher than the 600 USD per test previously disclosed. The price has been adjusted to reflect recent payer studies, which have shown strong price elasticity and health economic benefits even at a higher price...Immunovia is launching the IMMrayTM PanCan-d test for those individuals with CA19-9 levels greater than 2.5 U/ml."
Pricing • Launch US
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IMMray™ PanCan-d
over1year
Immunovia, Inc. Receives Approval to Begin Testing Patients for Pancreatic Cancer with the IMMray PanCan-d Test (Immunovia Press Release)
“Immunovia…announced that Immunovia, Inc. has received final approval to begin patient testing for the IMMray PanCan-d test - the first blood test on the market dedicated to the early detection of pancreatic cancer. This approval was received from the Massachusetts Department of Public Health on August 3, 2021. Immunovia, Inc. received its CLIA Certificate of Registration on June 21, 2021 (CLIA Number: 22D2227265). As a result, Immunovia, Inc. can immediately begin selling the IMMray™ PanCan-d test for early detection of pancreatic cancer in the US exclusively through their laboratory in Marlborough, Massachusetts.”
Regulatory
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IMMray™ PanCan-d
almost2years
Immunovia presents update on US market size for IMMray™ PanCan-d in the familial/hereditary risk group (Immunovia Press Release)
"Immunovia today announced an updated assessment of the total market size for familial/hereditary pancreatic cancer risk group in the US. New estimations show that 315,000 – 350,000 individuals have a familial/hereditary risk for pancreatic cancer and would qualify to be enrolled in pancreatic cancer surveillance programs...Updated guidelines from US Preventive Services Task Force (USPSTF), National Comprehensive Cancer Network (NCCN), American Society of Clinical Oncology (ASCO), and the International Cancer of the Pancreas Screening (CAPS) Consortium all conclude that the general population should not be screened for pancreatic cancer...The updates of the guidelines has led the company to re-examine the potential market size for surveillance of high-risk individuals in the familial/hereditary risk group."
Clinical
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IMMray™ PanCan-d
almost2years
Immunovia reiterates its road to reimbursement for the IMMray™ PanCan-d test (Immunovia Press Release)
"Immunovia is launching its IMMray™ PanCan-d test in the US as a Laboratory Developed Test (LDT) in Q2 2021. The company will explore a positive Medicare coverage determination for the IMMray™ PanCan-d test through the Local Coverage Determination (LCD) process."
Reimbursement
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IMMray™ PanCan-d
almost2years
Immunovia reports positive results of the blinded clinical validation of IMMray PanCan-d blood test in USA (PRNewswire)
“Immunovia today announced the successful completion of the last development milestone of IMMray PanCan-d blood test designed for early detection of pancreatic cancer (PDAC). The blinded validation study data demonstrated that Immunovia's IMMray PanCan-d biomarker signature and CA 19-9 detects early stage I&II pancreatic cancers with a test specificity/sensitivity of 98%/85% vs familial/hereditary controls...and with a specificity/sentitivity of 99%/85% vs healthy controls. All stages of PDAC were detected with a specificity of 98% and a sensitivity of 87% against familial/hereditary controls.”
Clinical data
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IMMray™ PanCan-d
almost2years
Immunovia reports improved test performance of IMMray PanCan-d in detecting early stage pancreatic cancer in high risk symptomatic patients (PRNewswire)
“Immunovia today announced improved performance of its blood based IMMra PanCan-d biomarker signature together with CA 19-9, in a clinical retrospective study. The study was designed to evaluate detection of early stage pancreatic cancer in high risk patients with non-specific but concerning symptoms. The study data demonstrate that Immunovia's test now detects pancreatic cancers (all stages) with 92% specificity and 81% sensitivity for this cohort, which is equivalent to results presented in the previous Commercial Test Model Study (link to PR). Importantly, early stage PDAC I/II were detected with specificity of 92% and sensitivity of 80%.”
Clinical
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IMMray™ PanCan-d
over2years
Immunovia Announces Positive Results from the IMMray PanCan-d Verification Study (PRNewswire)
"Immunovia...announced positive results from the verification study and will now commence the validation study, the last step towards the launch of IMMray™ PanCan-d. The verification study analysis shows results in line with the previous commercial test model study (CTMS), which paves the way for the final blinded validation study...The study was performed in order to verify the IMMray™ PanCan-d commercial biomarker signature using known samples and to further validate its accuracy in differentiating PDAC (pancreatic ductal adenocarcinoma)..."
Clinical data
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IMMray™ PanCan-d