PERTH, Australia – As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities.

LONDON – A new technique for analyzing solid tumor DNA has been shown to significantly improve scoring of mutation burden, making it possible to identify patients who will respond to immunotherapy.

Denver-based Biointellisense Inc. has unveiled Biobutton, a coin-sized, disposable medical device that measures continuous temperature and other vital signs for 90 days. The device, coupled with HIPAA-compliant data services, permits remote data capture and continuous multiparameter monitoring of temperature, respiratory rate and heart rate at rest, body position, sleep and activity state.

HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.

Several companies have reported quarterly results over the past couple of days, and those offering testing for COVID-19 have seen impressive numbers. Standing out was San Diego-based Quidel Corp., whose numbers caught the attention of William Blair’s Brian Weinstein. Indeed, its $174.7 million in revenue far exceeded his organization’s estimate of $160 million, driven by influenza.

Liquid biopsy startup Grail Inc., of Menlo Park, Calif., has reeled in $390 million in a series D financing that included new investors Public Sector Pension Investment Board and Canada Pension Plan Investment Board. Prior investor Illumina Inc., of San Diego, also participated in the round, as well as two unidentified backers.

As states in the U.S. move past the initial push for tests to identify active COVID-19 infections, antibody tests are ramping up quickly to aid in disease surveillance and return-to-work screenings. The rush has spurred an explosion in serology tests, many hastily developed and of questionable value. However, as the pandemic enters its third month, some companies are offering high-accuracy tests with validated results.

The challenges to deploy diagnostic and surveillance testing for the COVID-19 pandemic will persist at least until a vaccine is ready if not well beyond that milestone. The state of COVID-19 testing as a regulated sector is a complex intersection of new and old technologies, questionable accuracy, availability hurdles, supply chain interruptions and problems with interpretation of results.

The COVID-19 pandemic has shaken the world – and the face of diagnostics. In a matter of weeks, a host of companies has worked to develop tests to find those patients who currently have the disease, as well as those who have developed antibodies.