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.
Intensity Therapeutics restarts breast cancer Phase 2 clinical trial
Merck reports positive Phase 3 results for KEYTRUDA in advanced endometrial cancer
Kelun-Biotech's Phase III study of sac-TMT in combination with pembrolizumab meets primary endpoint
AstraZeneca signs global licence deal with Dizal for lung cancer drug Zegfrovy
Summit Therapeutics sells Phase III antibiotic asset ridinilazole to Biossil
European Commission approves Erbitux combination for first-line BRAF V600E-mutant mCRC
Newbury Pharmaceuticals receives Swedish approval for generic tofacitinib
HDT Bio Launches Canadian clinical programme for brain cancer treatment
Accord BioPharma's second pegfilgrastim biosimilar to NEULASTA approved by US FDA
BiBBInstruments signs first European distribution deal for EndoDrill GI with Palex Spain
Northwest Biotherapeutics presents updated DCVax-L Phase III trial survival data for glioblastoma
HanchorBio plans combination research with late-stage cancer drug resistance specialist InxMed
GE HealthCare and Mayo Clinic launch prostate cancer theranostics research study
Physiomics secures new contracts worth over GBP200,000
Wiley announces launch of Advanced Immunology open access journal