Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.
The companies plan to develop a broad NGS panel to analyze all known biomarkers for cancer drugs, including tumor mutation burden and microsatellite instability.
A private payor survey by ClearView Healthcare Partners found that medical directors viewed CMS's decision with caution; half had no plans to align commercial plan coverage.
The ctDNA assay will be used to select patients for Phase 3 of Five Prime's registrational trial investigating bemarituzumab in gastric cancer patients.
The firm is in the midst of evaluating its strategic options and has hired Raymond James to assist in the process, which could include the sale of the firm, it said.
The test is approved as a companion diagnostic that can determine which advanced breast cancer patients have BRCA1/2 genetic mutations and will likely respond to Lynparza.
A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.
The investment bank gave the company's stock an Outperform rating with a target price of $90 per share.
The proteomics firm is swapping 4 million of its shares for a 10 percent interest in CPR with the goal of moving into clinical trials and related research.
BMS amended an ongoing Phase III study of Opdivo and Yervoy to evaluate outcomes based on tumor mutational burden using Foundation Medicine's NGS companion diagnostic.
Executives at two commercial payors said they'd follow CMS' lead when it comes to patients covered under Medicare but beyond that their support for the agency's policy is less clear.
The firm's CEO said he's seeing significant growth in research applications from its RNA in-situ hybridization technology, and sees potential for its use in clinical settings.
The project relates to an NGS-based clinical trial assay associated with a sponsored project agreement between Qiagen and an undisclosed pharmaceutical company.
CureOne also received CMS's approval for 11 quality metrics around biomarker testing that doctors can report for MIPS-related payment.
Under the agreement, new companion diagnostics will be included in updates to FoundationOne CDx, which was recently FDA approved.
Myriad Genetics' BRACAnalysis CDx can identify which metastatic patients have BRCA mutations and would likely benefit from treatment with AstraZeneca's Lynparza.
The companies are aiming to develop Idylla-based CDx biomarker tests for a compound Amgen is developing to treat solid tumors.
The year brought more FDA approvals for molecularly targeted drugs and NGS tests for personalizing cancer treatment, but reimbursement remained a stress point for industry.
The drugmaker will use Myriad's expanded molecular diagnostic panel to evaluate best responders to a combination of Lynparza and Avastin in clinical trials.
The next-generation sequencing test will be used to select patients for a clinical trial of Locus' Pseudomonas aeruginosa antimicrobial product.
An Australian-led team has generated a draft genome assembly of the invasive cane toad in hopes it will help in population control, the Sydney Morning Herald reports.
The New York Times reports that the US Department of Defense has implemented about half the recommendations made to improve safe handling of dangerous agents.
In PLOS this week: approach for teasing out archaic introgression in human genomes, immune transcription features in HCV infection, and more.
Stat News reports that Maryland is promoting itself to the biotech industry with a mobile billboard.