The U.S. capacity for SARS-CoV-2 testing is limited by a number of items, including the swabs used to collect patient specimens, but the supply of reagents has been front and center recently. Despite those concerns, several private test makers said they are quickly ramping up production, including Thermo Fisher Scientific Inc., of Waltham, Mass., which said it has enough supplies of all types on hand to provide two million reactions per week, a volume that should increase to five million per week in April.
White House: Much more money needed to battle COVID-19
As the world goes to war with COVID-19, the U.S. is ripping open the purse strings to fund mobilization against both the coronavirus and the economic devastation it’s causing. The Trump administration last night sent Congress a second fiscal 2020 supplemental spending request. This one is for $48.5 billion, more than nine times the $8.3 billion authorized in the first supplemental that was signed into law just 12 days ago. “With the pandemic growing, resource needs have also grown,” Russell Vought, acting director of the White House Office of Management and Budget, said in the request. He cited the need to cover unanticipated costs federal agencies are facing in their response to the outbreak. In addition to the supplemental, the White House amended its fiscal 2021 budget proposal to include a 19% increase in funding for the Centers of Disease Control and Prevention and an 8% increase for the NIH’s National Institute of Allergies and Infectious Diseases.
Ventec joins COVID-19 fight with multifunction ventilator
With the high need for ventilators in the face of COVID-19, Ventec Life Systems is stepping up with its multifunction ventilator, known as VOCSN, for ventilation, oxygen, cough, suction and nebulization. The company recently closed $20 million in series E funding, bringing its total raised to $60 million. It expects to use the financing to expand the commercialization of the multifunction ventilator, boost its sales footprint, and develop additional product enhancements.
Verily uses COVID-19 to expand Project Baseline, aims to quell rampant privacy concerns
Google sister company Verily Life Sciences LLC has been under an unprecedented amount of scrutiny since it was promoted over the weekend by President Donald Trump as responsible for a nationwide information and testing program for the emerging novel coronavirus. But, in fact, the existing version is a pilot program in two California Bay Area counties that reportedly only processed 20 tests on Monday, it’s first day of operation. The South San Francisco, Calif.-based company is incorporating the coronavirus testing as part of its existing Project Baseline, a longitudinal study that was designed to monitor 10,000 people to assess various health data to better understand when health tips into disease. Started in 2017, the four-year study officially is no longer enrolling and is slated to report data in December 2023. But Verily allows an unlimited number of participants in a Project Baseline registry, from which the actual study participants are selected. It is using the pilot COVID-19 program, which is being created in cooperation with California public health authorities, to further expand upon Project Baseline by offering to enroll those tested for the novel coronavirus into the study.
Eye disease-focused Sight Sciences raises $30M in series E
Sight Sciences Inc., of Menlo Park, Calif., scooped up $30 million in a series E preferred stock financing round that was led by D1 Capital Partners. The funds are earmarked to further advance clinical and operational development and support commercial expansion of the company’s Omni surgical and Tearcare systems. The company focuses on treatments for glaucoma and dry eye disease.
TGA refines proposals to reclassify six groups of medical devices based on industry comments
PERTH, Australia – Six classes of medical devices listed on Australia’s Register of Therapeutic Goods (ARTG) will fall under new classification requirements on Aug. 25, 2020, following numerous consultations with industry. The consultations were part of the Australian government’s plans to overhaul its medical device regulations to be more in line with the European Medical Device Regulation (MDR). Australia’s Therapeutic Goods Administration (TGA) has refined numerous proposals after receiving comments from industry, and those changes were endorsed by Parliament to amend the Therapeutic Goods (Medical Devices) Regulations 2002. Although the regulatory amendments come into effect on Aug. 25, 2020, manufacturers will have a four-year transition period until Oct. 31, 2024.
Free access to BioWorld coronavirus articles
The articles from BioWorld’s ongoing coverage of the COVID-19 coronavirus outbreak are available at www.bioworld.com/coronavirus. The collection includes breaking research, clinical, regulatory and business development news on coronaviruses reaching back to 1991. Featured topics: vaccines and diagnostics in development, the science underpinning the virus, comparison to previous outbreaks such as Severe acute respiratory syndrome (SARS) and Middle Eastern respiratory syndrome coronavirus (MERS-CoV), global regulatory factors and the business news underpinning the research including development collaborations and investment trends. A list of all vaccines and therapeutics in development can be found at www.bioworld.com/covid19products; information on diagnostics is available at www.bioworld.com/COVID19diagnostics.
Also in the news
Ambu, Attc, Biointellisense, Biomerica, Bio-Techne, Canon Medical, Dover, E25bio, Em-tec, Endologix, Helius Medical Technologies, Lllamasoft, Myriad Genetics, National Comprehensive Cancer Network, Parallax, Quidel, Rewalk, Tabula Rasa Healthcare, Wingdo