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.
Diagnosis and treatment of infections typically occurs after people exhibit obvious signs of illness, such as fever or a cough. By then, they may already have exposed others and are well on the way to developing more serious symptoms themselves. In the military, such delays can hamper medical countermeasures to contain potential outbreaks and reduce downtime among active duty personnel. Now, Amsterdam-based Royal Philips NV and the U.S. Department of Defense's Defense Threat Reduction Agency and Defense Innovations Unit have built an early warning algorithm – using artificial intelligence – to detect infection before a person shows any signs or symptoms of infection.
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.
Magnetic resonance imaging (MRI) machines typically require a dedicated shielded room, as well as an additional room with electronics for analytics. That makes MRI, with a typical costly system that requires whole body immersion and elaborate facilities, not particularly feasible for many health care settings.
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.
CEO Mark McKenna told BioWorld MedTech that San Diego-based Prometheus Biosciences Inc. has "cracked the code" in inflammatory bowel disease (IBD) – progress underscored by the firm's deal with Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, which brings an undisclosed up-front payment and as much as $420 million more if development, regulatory and commercial milestones are reached in three programs.
HONG KONG – In vitro diagnostic company Cube Bio Co. Ltd., of Seoul, South Korea, has inked an agreement worth KRW3 trillion (US$2.5 billion) with Moscow-based Standart-Biotest LLC to export its cancer self-diagnostic kits for five years to Russia and the Commonwealth of Independent States (CIS).
PERTH, Australia – Australia's Therapeutic Goods Administration (TGA) is seeking comments from stakeholders on whether certain self-testing in vitro diagnostics (IVDs) should be prohibited from being sold to consumers.
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