Clinical Sequencing

Elaine Mardis, co-director of the Genome Institute at Washington University in St. Louis, discussed genomic testing for cancer in both clinical research and diagnosis.

The company plans to bring both tissue-based and blood-based targeted sequencing tests through FDA clearance.

The companies are taking the CE-IVD route as opposed to the LDT model in the US due to Europe's distributed prenatal testing market and lower regulatory hurdles.

At the Molecular Medicine Tri-Conference, Guardant Health presented details from a 510-patient clinical validation study.

The lab plans to launch the LDT in the next three to six months with an eye toward US Food and Drug Administration clearance.

 

In Science this week: gene linked to expansion of the human neocortex, and more.

The National Institute of General Medical Sciences director says changes the agency made have allow it to boost success rates.

Ancient DNA indicates Stone Age, hunter-gather inhabitants of Britain imported wheat.

Joel Achenbach explores at National Geographic why people find science difficult to believe.