Immunovia's new lab staffed and operational after rapid implementation
Immunovia (NASDAQ: IMMNOV) has announced that its new lab in Research Triangle Park, USA, is now fully operational and staffed. The lab, focused on early detection of pancreatic cancer, was occupied on May 21, 2024, and all necessary equipment has been installed and validated. Two new scientists have been hired, and the team will validate assays developed with Proteomedix on an ELISA platform. The lab will conduct a clinical validation study of the next-generation test in Q4 2024. Immunovia has also filed to transfer its CLIA license and renew its CAP accreditation.
- New lab in Research Triangle Park is fully operational and staffed.
- Successful transfer and validation of protein assays to the new lab.
- Hiring of two skilled scientists to advance test development.
- Planned clinical validation study of the next-generation test in Q4 2024.
- Pending transfer of CLIA license and renewal of CAP accreditation.
Immunovia announced on 29 April the company's plans to streamline its lab operations and move to Research Triangle Park (RTP), following the successful model development study of the next generation test. After taking occupancy on 21 May 2024, Immunovia is today announcing that its lab is fully operational and staffed.
All lab equipment is installed and validated. Systems for document control and quality management have been implemented. The new lab is also fully staffed following the hiring of two new scientists.
The protein assays for Immunovia's next-generation test, developed in collaboration with Immunovia's partner Proteomedix, have been successfully transferred to the lab. The assays are performed on an ELISA platform and are faster, cheaper, and less-labor intensive than Immunovia's prior proprietary IMMray platform.
Under the leadership and direction of Dr. Lisa Ford, the team in Research Triangle Park will focus next on confirming the analytical validity of these assays. Immunovia's team will validate the assays according to relevant regulatory guidance, including CAP, CLIA and CLSI. The lab will then conduct a large clinical validation study of the next-generation test in the fourth quarter of 2024.
"We are excited to announce that our new lab is fully operational and staffed. We have recruited two talented scientists, Dr. Robyn Pescatore and Dillon Josey, who will focus on the continued development of Immunovia's next generation test," says Dr. Lisa Ford, Clinical Lab Director.
"The lab move to Research Triangle Park illustrates the speed, efficiency and productivity of the new Immunovia. Lisa and her team have accomplished a tremendous amount in just six weeks. The Immunovia team is moving quickly to meet the substantial market demand for a simple and affordable blood test for early detection of pancreatic cancer," says Jeff Borcherding, CEO and President of Immunovia.
Immunovia has filed to transfer its CLIA license from the lab in Marlborough to the new lab in Research Triangle Park. The company will also be renewing its accreditation with the College of American Pathology (CAP).
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.
Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com
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SOURCE Immunovia AB
FAQ
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