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.
The test measures minimal residual disease and can be used to monitor patients eligible for discontinuation of treatment with Tasigna.
Proteomics International's PromarkerD will be tested in clinical studies alongside Dimerix's investigational chronic kidney disease drug DMX-200.
In a Phase III trial, talazoparib-treated patients had a three-month median progression-free survival advantage over patients treated with chemotherapy chosen by their doctors.
The tests were developed as part of a partnership with Merck KGaA, one of the manufacturers of the anti-EGFR therapy Erbitux.
CEO Anders Rylander said the company will initially market its DiviTum assay for breast cancer cases, though it could be used to monitor cell proliferation in all cancer types.
With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.
NPR reports that government and private insurers are being slow to cover recently approved CAR-T cell therapies.
CNBC reports that there are thousands of genetic tests available for consumers to chose between.
In Nature this week: genomic analysis of ducks, whole-genome doubling among tumor samples, and more.