Summary: Immunovia has opened a new lab in Research Triangle Park, NC, which is now fully operational and staffed, marking a significant step towards enhancing early detection of pancreatic cancer.

Takeaways:

  1. Lab Transition: Immunovia’s new lab in Research Triangle Park is fully operational as of May 21, 2024, following a swift transition.
  2. Next-Generation Test: The lab will focus on validating and conducting a large clinical study for a faster, cheaper next-generation pancreatic cancer detection test.
  3. Regulatory Compliance: Immunovia is in the process of transferring its CLIA license and renewing its CAP accreditation for the new lab.

Immunovia, a diagnostics company seeking to increase pancreatic cancer survival through early detection, released an update on its new lab in Research Triangle Park, NC. 

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 has announced that its lab is fully operational and staffed. 

“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. 

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.

Next-Generation Pancreatic Cancer Test up and Running

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 Lisa Ford, PhD, HCLD (ABB), 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 Ford, who serves as the clinical lab director. 

CLIA License Transferred

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).