Devices

Qiagen, Myriad Partner on Cancer Diagnostics

Qiagen and Myriad Genetics say they have a master collaboration agreement to develop cancer companion diagnostic tests. A Myriad statement says the partnership aims to deliver innovative services and products to pharmaceutical companies, enabling the development and commercialization of proprietary cancer tests for the U.S. clinical market, and providing distributable companion diagnostic test kits for the global market.

The collaboration comes as FDA aims to crack down on laboratory-developed tests (LDTs), such as those often used when a companion diagnostic is not approved for selecting qualified patients for an oncologic therapeutic. The agency recently published a proposed rule to increase its scrutiny of such tests that have grown in use and complexity over many years.

Additionally, FDA recently launched a new pilot program to add more regulatory teeth to LDTs that are used without an approved companion diagnostic for certain oncology drugs (see story). Under the pilot, FDA will prospectively ask drug manufacturers during their meetings to discuss pivotal trials for performance information for the tests used to enroll patients into clinical trials that support drug approval. Oncology Center of Excellence director Rick Pazdur said at a recent meeting that if successful, the pilot could eliminate the “bridging that has to happen between what was used in the clinical trial versus what an approved test would be.”

Qiagen and Myriad Genetics’ statement says the initial project focus for the two companies will involve collaborating with drug company partners to develop assays using next-generation sequencing workflows of Qiagen’s digital polymerase chain reaction platform.

Future projects are under consideration, it says, to explore advancing and kitting next-generation detection of measurable residual disease and homologous recombination deficiency.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome