Navidea Biopharmaceuticals Inc. disclosed positive results from the first interim analysis of its ongoing NAV3-31 phase IIb study. Analysis shows the data support Navidea's hypothesis that Tc 99m tilmanocept imaging can provide robust, quantitative imaging in healthy controls and in patients with active rheumatoid arthritis (RA).

The U.S. Centers for Medicare and Medicaid Services (CMS) has posted a draft rewrite of the coverage memo for next-generation sequencing (NGS), and while the draft rewrite fails to address a number of concerns, the agency eliminated references to advance-stage cancer, opening the door to considerably greater utilization.

A JAMA Open Network study found that RNA testing determined whether 88% of variants of uncertain significance found in DNA testing for hereditary cancer genes were pathogenic or benign.

LONDON – Pfizer Inc. is taking further steps to distinguish its third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena, from the rest of the field, funding a pan-European trial that will use liquid biopsies to track the resistance profile of non-small-cell lung cancers (NSCLC).

Genomic testing firm Veracyte Inc. is eyeing 2021 for the launch of its noninvasive nasal swab classifier for early lung cancer detection and diagnosis, following preliminary clinical data demonstrating high sensitivity in low-risk patients and high specificity in high-risk patients with known lung nodules. The South San Francisco-based company is developing the nasal swab test in collaboration with Johnson & Johnson Inc.'s Lung Cancer Initiative, part of a long-term strategic collaboration that also aims to speed commercialization of Veracyte's Percepta genomic sequencing classifier.

LONDON – A U.K. national plan to upgrade population cancer screening will see greater adoption of genomics and biomarker-based testing, and the use of artificial intelligence to help interpret results. There will be moves to make it easier to pilot and adopt novel diagnostics and to do more targeted screening to identify and follow people who are shown to be at greater risk of developing specific types of cancer.

HONG KONG – Singapore's Tan Tock Seng Hospital and Lucence Diagnostics Pte. Ltd. have teamed up to develop a next-generation decision support tool for liver cancer patients. The visualization tool, known as Liver3D, was designed to reduce the risks associated with liver cancer surgery. It does so by developing machine learning models based on radiology images of liver cancer patients for clinical decision support.

Foundation Medicine Inc., of Cambridge, Mass., has had a busy fall, and it is showing no signs of letting up. For example, in the next 12 to 18 months, the company has high hopes for its Foundationone Liquid test, David Fabrizio, VP, product development, told BioWorld MedTech during a visit to its headquarters last month as the Medtech Conference wrapped up in Boston. "This is one that we are actively engaged in with FDA and planning to submit and hopefully get approval and launch mid-next year," he added.