Immunovia's new lab staffed and operational after rapid implementation

Rhea-AI Summary

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.

Positive

• 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.

Negative

• Pending transfer of CLIA license and renewal of CAP accreditation.

LUND, Sweden, July 2, 2024 /PRNewswire/ -- Immunovia (NASDAQ: IMMNOV) (STOCKHOLM: IMMNOV), the diagnostics company seeking to increase pancreatic cancer survival through early detection, today offers an update on its new lab in Research Triangle Park, USA. 

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. 

USA is the world's largest market for detection of pancreatic cancer. The company estimates that in the USA, 1.8 million individuals are at high-risk for pancreatic cancer and could benefit from annual surveillance testing. 

Immunovia's shares (IMMNOV) are listed on Nasdaq Stockholm. For more information, please visit www.immunovia.com 

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/immunovia-ab/r/immunovia-s-new-lab-staffed-and-operational-after-rapid-implementation,c4009602

The following files are available for download:

https://mb.cision.com/Main/13121/4009602/2895437.pdf

Press release (PDF)

 

View original content:https://www.prnewswire.com/news-releases/immunovias-new-lab-staffed-and-operational-after-rapid-implementation-302187809.html

SOURCE Immunovia AB

FAQ

What recent update did Immunovia (IMMNOV) announce about their new lab?

Immunovia announced that their new lab in Research Triangle Park, USA, is fully operational and staffed as of July 2, 2024.

When did Immunovia take occupancy of their new lab in Research Triangle Park?

Immunovia took occupancy of their new lab on May 21, 2024.

What platform are the protein assays performed on at Immunovia's new lab?

The protein assays at Immunovia's new lab are performed on an ELISA platform.

When is the clinical validation study of Immunovia's next-generation test scheduled?

The clinical validation study of Immunovia's next-generation test is scheduled for the fourth quarter of 2024.

What regulatory steps is Immunovia taking for their new lab?

Immunovia is transferring its CLIA license and renewing its CAP accreditation for the new lab.