LDTs
EU IVDR Implementation Woes Could Severely Limit Cancer Companion Test, Precision Therapy Access
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The EC has stuck with its timeline to implement the new regulations in eight months, raising concerns for cancer patients' ability to receive biomarker testing and treatments.
European laboratories that modify existing assays or make their own tests to better care for patients are staring at a substantial increase in oversight.
20/20 GeneSystems Accelerator Program Allows International Dx Companies to Build US Business
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The accelerator provides laboratory space, marketing and regulatory guidance, and supplies to firms looking to set up in the US.
Phosphorus Wins Conditional New York State Approval for GeneCompass Consumer Test
The firm's health screening sequencing assay, which retails at $249 and covers a panel of over 400 genes, will now be available to consumers in all 50 states.
Immunovia Receives Massachusetts Approval to Begin Testing of Patients for Pancreatic Cancer
The firm said its laboratory developed test, which recognizes biomarker signatures in the blood, can detect pancreatic cancer early when surgical resection is possible.