Genetron Holdings Ltd. said its blood-based, early screening test for hepatocellular carcinoma (HCC) demonstrated 88% sensitivity and 93% specificity in 1,615 subjects in China vs. 71% sensitivity and 95% specificity with the use of ultrasound plus alpha-fetoprotein (AFP). The primary outcome, unveiled on March 25, came from a multicenter prospective trial that Beijing-based Genetron initiated together with The National Cancer Center China in 2019.

The rapidly expanding field artificial intelligence (AI)-aided image analysis received a boost with the FDA 510(k) clearance for Optellum Ltd.’s Virtual Nodule Clinic, which helps clinicians evaluate small, potentially malignant lung lesions or nodules. The action makes Optellum’s system the first cleared radiomic application for early lung cancer, an area of active research for the last five years.

The FDA is becoming more amenable to screening and surveillance tests for the COVID-19 pandemic, although the distinction between test uses is not always clear. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the agency’s weekly town hall that the difference between surveillance and screening tests is whether the individuals who are screened can act on the information thus derived.

Although artificial intelligence (AI) seems to be making only incremental headway in the world of medical technology, Brainscope Co. Inc., continues to advance its AI offerings with the launch of the Concussion Index (CI). This algorithm, used with the company’s disposable headset, has been demonstrated to reduce the need for cranial CT scans by 30%, making this a double win for patients and for health care spending in the U.S.

PERTH, Australia – Australia’s Therapeutic Goods Administration (TGA) released three final guidances on its expectations on clinical performance requirements and risk mitigation for in vitro diagnostic (IVD) self-tests. The guidances outline clinical performance requirements and key risks that must be mitigated for IVDs to be used as self-tests for seasonal influenza; hepatitis B virus (HBV) and hepatitis C virus (HCV); and chlamydia, gonorrhea; and syphilis.

The COVID-19 pandemic has affected wide swaths of the global economy, mostly in a negative manner, but it has spurred some types of innovation at a rate that would be unimaginable in ordinary times. That seems to be the take-away for an emergency use authorization (EUA) granted to Miami-based Tiger Tech Solutions Inc. for its COVID Plus monitor, which uses plethysmography and a machine learning algorithm to provide a screening mechanism at mass gatherings, thus bringing the world one step closer to a state of normalcy.

PERTH, Australia – With a fresh injection of A$28.9 million (US$22.4 million) in grant funding from the Australian government and a capital raise of A$40 million, 4dmedical Ltd. is well on its way to commercializing its first lung imaging product in the U.S. and Australia. 4dmedical’s X-ray velocimetry (XV) technology is the first FDA-cleared respiratory imaging solution that uses mathematical models and algorithms to convert sequences of X-ray images into four-dimensional quantitative data.

The administration of President Joseph Biden announced March 17 a $10 billion allocation of funds for testing to reopen schools in the final months of the current school year, a source of revenues that was provided by the recently passed $1.9 trillion American Rescue Plan. The news follows by one day a new FDA policy on screening tests that allows test developers to distribute tests designed to screen those who are asymptomatic without first validating the test for this use, although there are still questions as to whether this new push will yet again crimp vital testing supplies.