The multi-center registry study aims to measure the clinical impact of serial testing with Signatera in patients with stage II or stage III colorectal cancer.
Luminex got the nod for a qualitative test used to simultaneously detect and identify nucleic acids from respiratory viruses and bacteria.
The CVS-Tempus partnership aims to streamline the cancer care process for patients from the point of prescribing onwards and connect patients with local trials.
Palmetto has expanded coverage of the ClonoSeq assay to include monitoring MRD testing for patients with chronic lymphocytic leukemia (CLL.)
The IVD test will adjust for isatuximab-induced interference in immunofixation electrophoresis tests, which can mislead clinicians in interpreting patient response.
While it was developed and validated for brain tumor classification, the workflow could be extended to other cancers where intraoperative histology is valuable.
As part of the collaboration, UNC will use the firm's BarreGen assay to target molecular changes to predict resistance or relapse following ablation.
A federal court said Guardant CEO Helmy Eltoukhy deleted emails pertaining to two similar cases, but it remains unclear whether he did so intentionally.
The company will use the proceeds to strengthen its balance sheet and support the commercial launch of new products and development activities over the coming year.
Developers pointed to some success, but they also noted that more at-home tests need to demonstrate higher levels of performance and affordability.
The LCD for the RNA gene expression test will take effect on Feb. 10, 2020, the Medicare contractor said.
Despite the availability of more precision therapies and complex biomarker tests, systemic gaps and lack of physician education continued to hinder access.
The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.
The investment bank gave PerkinElmer an Outperform rating with a $114 stock price target and Hologic an In Line rating with a $55 stock price target.
The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.
Companies developing tests for cancer therapy selection, therapy monitoring, and screening received most of the private investment, funding experts said.
The company plans to make its PRS offering, currently used only in those who test negative for gene mutations, an option for all customers of European ancestry.
Simulations suggested prostate cancer screening informed by polygenic risk scores is more cost effective and less prone to overdiagnoses than screening based on age alone.
The first phase of the study to evaluate Telo Genomics' telomere analytics as a prognostic solution for multiple myeloma is expected to launch in Q1 2020.
The Parsippany, New Jersey-based firm expects to expand relationships with multiple biopharmaceutical companies after bolstering its biopharma services business.