Healthcare Roundup – Feds to ship Abbott’s $5 rapid COVID-19 tests, Roche to launch rapid coronavirus antigen test in CE Mark countries
Feds to ship Abbott’s $5 rapid COVID-19 tests to states
The U.S. government plans to distribute almost all of Abbott’s (NYSE:ABT) rapid COVID-19 test that it recently bought, 150M units at $5 each, to the states where they can use them to help reopen schools and protect first responders.
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Shipments to governors will begin mid-month.
The tests will also be sent to assisted-living facilities, senior centers, home health personnel and nursing homes. In addition, they will be used to boost screenings in populations of color via historically Black colleges/universities and Native American tribes.
Roche to launch rapid coronavirus antigen test in CE Mark countries
Roche (OTCQX:RHHBY +1.8%) plans to launch its SARS-CoV-2 Rapid Antigen Test later this month in markets that accept CE Mark certification.
It expects to file for emergency use authorization in the U.S.
The point-of-care chromatographic assay can generate a result in 15 minutes without the need for instrumentation. The company says it has 96.5% sensitivity and 99.7% specificity based on 426 nasopharyngeal swab samples from two independent study centers.
At launch, production volume will be 40M units per month which will ramp to more than 80M per month by year-end.
FDA OKs Bristol Myers’ azacitidine for certain leukemia patients
Under Priority Review status, the FDA approves Bristol Myers Squibb’s (BMY -2.1%) Onureg (azacitidine 300 mg tablets) (formerly CC-486) for the continued treatment of adult acute myeloid leukemia (AML) patients who achieved first complete remission (CR) or CR with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy.
Its application in Europe is under EMA review.
Quest under pressure on dustup in Florida over COVID-19 testing issues
Quest Diagnostics (DGX -2.7%) is down on average volume on the heels of a tweet from the Florida Department of Health taking the company to task over, what appears to be, a dump of a large number of overdue COVID-19 test results. Governor Ron DeSantis has ordered all state executive agencies to sever ties with the reference lab effective immediately.
Specimen collection sites in the U.S. have complained about the slow turnaround of results from contracted diagnostic labs, not just Quest, since delays undermine intervention efforts on people who test positive. Labs cite supply chain issues preventing timely procurement of essential supplies to run the tests.
LabCorp (LH -1.3%) and OPKO Health (OPK -4.2%) are down in sympathy.
Update: In a statement, Quest says a technical issue delayed the reporting of results on ~75K tests, a subset of the ~1.4M tests performed and reported to the state thus far. It apologizes for the snafu, adding that the issue has been resolved.
Northwest Biotherapeutics high on Flaskworks acquisition
Executed and closed on August 28, 2020, Northwest Biotherapeutics (OTCQB:NWBO +5.4%) acquired Flaskworks, a developer of breakthrough system to close and automate the manufacturing of cell therapy products such as DCVax, for $4.3M.
Out of the total purchase price, $1.65M was paid in cash at closing, up to $2.01M will be paid in stock subject to milestone-based vesting, and $0.67M will be paid in either cash or stock, or a combination thereof, within 120 days after the closing.
Acquisition includes both intellectual property owned by Flaskworks and a license of additional intellectual property from Northeastern University.
Flaskworks system will enable substantial scale-up of production volumes of DCVax products and substantial reduction of production costs.
“We believe that our DCVax platform technologies are potentially applicable to all types of solid tumor cancers, which comprise the vast majority of all cancers,”CEO Linda Powers commented; expects to reach results of its Phase 3 clinical trial of DCVax-L for Glioblastoma.