01:12 , Jun 1, 2019 |  BioCentury  |  Product Development

Clinical trial and regulatory efficiency get help from ctDNA, RWE at ASCO19

This year’s crop of ASCO abstracts show companies are going full bore on pre- and post-market technologies that can speed up development and regulatory timelines. In BioCentury’s analysis of 4,627 abstracts, over 500 feature circulating...
00:27 , Apr 13, 2019 |  BioCentury  |  Tools & Techniques

ctDNA inches toward new applications

After establishing itself as a key tool for tumor profiling and patient stratification, circulating tumor DNA is now beginning to make the move into monitoring response to therapy, where it promises an early read of...
01:29 , Feb 1, 2019 |  BC Week In Review  |  Clinical News

OncoCyte's lung cancer liquid biopsy test shows 90% sensitivity

OncoCyte Corp. (NYSE-A:OCX) said its DetermaVu liquid biopsy test detected lung cancer with sensitivity of 90% and specificity of 75% in the prospective R&D Validation study in 250 patient blood samples. OncoCyte said it will...
12:02 , Jan 29, 2019 |  BC Extra  |  Clinical News

OncoCyte's lung cancer liquid biopsy test shows 90% sensitivity

OncoCyte Corp. (NYSE-A:OCX) said Tuesday its DetermaVu liquid biopsy test detected lung cancer with sensitivity of 90% and specificity of 75% in the prospective R&D Validation study in 250 patient blood samples. The news sent...
20:18 , Feb 23, 2018 |  BC Week In Review  |  Clinical News

Guardant gets EAP from FDA for NGS-based liquid biopsy

Guardant Health Inc. (Redwood City, Calif.) said FDA granted Expedited Access Pathway (EAP) designation to its Guardant360 assay, a comprehensive next-generation sequencing (NGS)-based liquid biopsy test for advanced cancer. The company plans to submit a...
00:27 , Feb 17, 2018 |  BC Extra  |  Company News

FDA grants EAP designation to Guardant's NGS-based liquid biopsy

Guardant Health Inc. (Redwood City, Calif.) said FDA granted Expedited Access Pathway (EAP) designation to its Guardant360 assay, a comprehensive next-generation sequencing (NGS)-based liquid biopsy test for advanced cancer. The company plans to submit a...
22:30 , Jan 4, 2018 |  BC Innovations  |  Strategy

Next generation resolutions

With a slew of landmark approvals in the last 18 months, FDA has solidified its commitment to advancing genetic diagnostics. Now the agency is turning to the outstanding challenges, with solutions on the horizon for...
23:22 , Oct 10, 2017 |  BC Extra  |  Politics & Policy

AZ, MSKCC highlight challenges in broader use of liquid biopsy

At a meeting co-hosted by FDA and the American Association for Cancer Research (AACR), representatives from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Memorial Sloan Kettering Cancer Center (MSKCC) pointed out challenges in extending the use of...
01:06 , Feb 17, 2017 |  BC Innovations  |  Strategy

Putting genes to the test

As new technologies fill the landscape of molecular diagnostics, two fault lines are becoming clear: next-generation sequencing versus PCR, and tumor biopsies versus ctDNA. But while stakeholders believe there’s room for it all, they warn...
07:00 , Oct 10, 2016 |  BC Week In Review  |  Clinical News

Cobas EGFR Mutation Test v2 regulatory update

FDA approved a PMA from Roche for a blood-based version of its cobas EGFR Mutation Test v2 as a companion diagnostic for Tagrisso osimertinib from AstraZeneca to treat EGFR T790M mutation-positive, metastatic non-small cell lung...