This report contains a quantitative, evidence-based scoring framework to help guide the evaluation of constitutional CNVs across clinical labs.
In a survey conducted by an association working group, 40 percent of respondents said they are already offering TMB, with most others planning to do the same within the year.
A preliminary analysis lends some support to covering NIPS for pregnancies beyond high-risk, and some payors have expanded coverage.
Invitae is providing the testing services as part of the 12-month pilot, while patients will have the option to share their results with researchers though LunaDNA.
CMS has attempted to address stakeholders' concerns about its coverage criteria for germline NGS testing in a new proposed national policy.
Circulating tumor DNA detection in stage III colon cancer patients after surgery and adjuvant chemotherapy coincided with a rise in recurrence risk.
The researchers said the test performed well in distinguishing patients with or without complications and proved itself better than frequently used clinical variables.
The study will evaluate how Prolaris impacts prostate cancer treatment decisions, and how those decisions impact costs within UK's National Health Service.
The team analyzed multigene panel test data from Ambry Genetics for 165,000 individuals, focusing on hereditary cancer risk related to 32 genes in six cancer types.
The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.
A European study, published today in NEJM, used a POC, PCR-based system to perform CYP2C19 genotyping to guide platelet inhibitor therapy.
Since 2016, the VHA has routinely profiled molecular features in advanced cancers from vets in its care, even in rural locales, though challenges remain.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
After reviewing more than 100 studies, the panel issued recommendations focused on women with a personal or family history of BRCA1/2-related cancers or high-risk ancestry.
The Cancer Journal documented 25 cases where inappropriate tests were ordered, variants were interpreted incorrectly, and wrong results were reported to patients.
The national project has developed infrastructure for implementing genomics into clinical care and is now studying clinical utility and cost effectiveness.
Biocartis' Idylla called some colorectal cancer samples negative that Sysmex Inostics's OncoBEAM called positive, but the clinical implications may be complex.
The bipartisan bill aims to provide federal support to children who are ill from an unknown cause and could gain insights into diagnosis or treatment approaches via WGS.
As NGS testing becomes more widespread, labs, payors, and professional groups confront questions about which genes should be required as part of clinical assays.
A Personalized Medicine Coalition-funded study has found that NGS-based testing is moderately cost effective but that access to targeted treatments remains a hurdle.