The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation

Oncology, Regulation, Testing, LDTs, FDA, CLIA, CMS

The regulatory landscape for precision oncology in the United States is complex, involving multiple governmental agencies with varying jurisdictions. Since 2014, several regulatory proposals have been introduced following the FDA's draft guidance on laboratory-developed tests. There are ongoing …

May 22^nd • 8 mins read

Transforming oncology: Five frontiers driving progress in cancer care

Thought Leadership, Oncology

From biomarker-driven breakthroughs to AI-powered early detection and a renewed commitment to equity and patient centricity, the past 12 months have seen major strides across cancer research, treatment, and communication. At Inizio, we’ve had a front-row seat to this transformation, supporting…

May 16^th • 5 mins read

Recent Trends in Medicaid Spending and Use of Drugs With US Food and Drug Administration Accelerated Approval

FDA accelerated approval, Medicaid spending, prescription drug costs, surrogate endpoints, cancer drugs, drug approval pathway

The study examines the impact of drugs approved through the FDA’s accelerated approval program on state Medicaid spending. From 1992 to 2020, 216 drug-indication pairs were granted accelerated approval, with a significant increase in cancer drug approvals in recent years. Although drugs wi…

Oct 8^th • 25 mins read