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.

Inflammatix Inc. raised $102 million in series D financing to advance development and commercialization of its novel immune response diagnostics portfolio. D1 Capital Partners led the round, with additional funds provided by existing investors Northpond Ventures LLC, Khosla Ventures, Think.Health GmbH, and OSF Healthcare Ventures, among others.

Roche Holding AG will acquire Genmark Diagnostics Inc. for $24.05 per share in cash for a total of $1.8 billion on a fully diluted basis. The transaction will give Basel, Switzerland-based Roche access to Genmark’s molecular diagnostics portfolio. The deal is expected to close in the second quarter of 2021. The price represents a 43% premium on the Carlsbad, Calif.-headquartered diagnostics company’s share price as of Feb. 10, prior to media speculation about a potential acquisition.

Variantyx Inc. raised $20 million in a series C financing led by GHS Fund (Quark Venture LP and GF Securities). The new funds are earmarked for the development of comprehensive tumor diagnostic solutions and sales expansion. Also taking part in the round were new investor IBM Ventures and existing investors Pitango Venture Capital, New Era Capital Partners and 20/20 Healthcare Partners. With this latest infusion, Variantyx has raised a total of $38 million.