Pancreatic cancer diagnostics company Immunovia AB (STO:IMMNOV) announced on Monday that it has received regulatory approval to offer its PancreaSure test commercially in California, marking a key milestone in its three-phase launch strategy.
The company will initially target leading medical centers that operate surveillance programs for patients at elevated risk of pancreatic cancer.
PancreaSure, a blood-based test for early detection of pancreatic cancer, has met both federal CLIA standards and California's additional state-specific laboratory requirements. Approval in California allows Immunovia to legally accept, analyze, and report test results from healthcare providers in the state.
California's large and strategically important market provides access to numerous academic medical centers and high-risk surveillance programs. The rollout enables Immunovia to scale use of the test and expand its commercial presence in the United States.
Hoth Therapeutics achieves European regulatory milestone for HT-001
AVEO Oncology reports first patient dosed in front-line AML combination study of ficlatuzumab
Rakuten Medical signs manufacturing agreement with LOTTE Biologics
Curasight reports preliminary data from Phase 1 trial in patients with high-grade gliomas
Abbisko Therapeutics reports US FDA acceptance of pimicotinib NDA
Summit Therapeutics and GSK form collaboration to study ivonescimab combination therapy
Summit Therapeutics submits FDA application for ivonescimab in EGFR-mutated lung cancer