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.
Despite improvements to sequencing technology, there are still significant challenges in developing clinical NGS-based gene panels.
In Nature this week: researchers classify pancreatic cancer into four subtypes using sequencing, and more.
Genotyping analysis of measles in Ontario indicates the strain there didn't originate from Disneyland or Europe.
The UK Medical Research Council says the proposed path of a new train line could affect research at the Francis Crick Institute.
The House of Lords in the UK approves a bill to allow mitochondrial donation.