CDx Partnership Bears Fruit with New FDA-Approved Test

This is an interesting example.

Predictive Biosciences Has Closed Due To Validation Requirement (Burrill Report article)

by John Audette | May 30, 2013 | Marketing, Test Developers, News

After raising over $30 million, and securing key channel access, Predictive Biosciences (developer of an LDT for bladder cancer) has closed operations because it couldn't afford the level of validation required by a payer.

Assay patenting instead of gene patenting to support diagnostic test development

Interesting point regarding alternative to gene patenting for diagnostics: assay patenting instead.

Barrier to Adoption: Uncertainty About Sample Requirements

Interesting survey (sponsored by Boehringer Ingelheim) of pulmonologists and pathologists regarding barriers to adoption of biomarker testing of lung cancer patients.




Pharmacovigilance and Safety Biomarkers

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