"We aimed for more tangible results of the PanFAM-1 study, which are partly inconclusive due to a variety of factors related to the execution of the clinical trial compared with original study design. The PanFAM-1 clinical study was also impacted by the COVID pandemic, when many hospitals were closed for the routine surveillance or screening of patients, as many others in the industry have experienced", said
Analysis of the sensitivity of IMMray(TM) PanCan-d in the PanFAM-1 study was confounded by the unexpectedly low 0.2% prevalence of PDAC in the PanFAM-1 cohort, which was lower than the c.1% prevalence in this risk group observed in other studies1, 2 and was lower than the prevalence assumed in the study design. In addition, the execution of the study was compromised by the following factors:
- The COVID pandemic significantly impacted the recruitment and monitoring of patients
- Insufficient number of serial blood draws and/or imaging for each patient
- Failure to provide a quality/accuracy assessment of imaging results
Analysts, investors and media are invited to a webcast and teleconference, today
PanFAM-1, background and details
PanFAM-1 was the first prospective, multi-center trial initiated by
Individuals enrolled in PDAC surveillance programs were planned to receive imaging and clinical evaluation at least once per year consistent with the study center's protocol (MRI, EUS or CT) and had a blood draw every 6 months. As an observational study, blood samples were frozen and stored until the IMMray(TM) PanCan-d test was clinically validated.
Samples were collected at 23 sites in the US (14) and
Statistical comparison of specific imaging findings and IMMray(TM) PanCan-d results is ongoing to examine trends in IMMray(TM) PanCan-d results relative to specific germline mutations, family histories, and imaging findings at the direction of the Principal Investigators in this study. Independent analysis of the PanFAM-1 results was conducted by Biostatisticians at the Biostatistical and Epidemiological Data Analysis Center (BEDAC) at
1 Overbeek KA, Levink IJ, Koopmann BDM et al. Long-term yield of pancreatic cancer surveillance in high-risk individuals. Gut. 2022;71:1152-1160.
2 Overbeek KA, Goggins MG, Dbouk M et al. Timeline of development of pancreatic cancer and implications for successful early detection in high-risk individuals. Gastroenterol. 2022;162:772-785.
Details for webcast and teleconference
Analysts, investors and media are invited to a webcast and teleconference today,
The presentation will be held in English and be followed by a Q&A session. You are welcome to join via webcast or phone, see details below.
Telephone numbers and webcast
Ring any of the numbers below to participate via telephone. Please dial in a few minutes before the presentation starts.
Link to the webcast: https://creo-live.creomediamanager.com/806a27cb-a49a-4fa9-b7e7-3ac9fd7a4795
To ask questions, it is necessary to dial in. A recording of the presentation will be available on
For more information, please contact:
CEO and President
philipp.mathieu@immunovia.com
Tobias Bülow
Senior Director Investor Relations and Corporate Communications
tobias.bulow@immunovia.com
+46 736 36 35 74
This is information that
About
Our first product, IMMray(TM) PanCan-d is the only blood test currently available specifically for the early detection of pancreatic cancer. The test has unmatched clinical performance. Commercialization of IMMray(TM) PanCan-d started in
The
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https://news.cision.com/immunovia-ab/r/panfam-1-results-partly-inconclusive,c3591702
https://mb.cision.com/Main/13121/3591702/1597357.pdf
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