A round up of the week's infectious disease pipeline developments.
Contagion offers daily coverage of developments in the infectious disease drug and medical device approval pipeline.
Since the emergence of the SARS-CoV-2 pandemic in particular, news in this space has moved at an accelerated pace.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Quest Diagnostics for specimen pooling via its proprietary molecular diagnostic test for coronavirus 2019 (COVID-19).
With the emergency indication granted this weekend, Quest Diagnostics is now the first lab in the US to receive FDA authorization for COVID-19 specimen pooling testing.
Pooling testing calls for the combination of individual specimen vials into small batches by laboratory investigators—creating an outcome of either a negative or positive result. If the batch is negative, all patients pooled in the test are considered negative. If the results are positive, each specimen is then retested individually.
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The US government will pay Pfizer and BioNTech $1.95 billion upon the receipt of the first 100 million doses of BNT162, following US Food and Drug Administration (FDA) authorization or approval. The US can also acquire up to an additional 500 million doses.
“Expanding Operation Warp Speed’s diverse portfolio by adding a vaccine from Pfizer and BioNTech increases the odds that we will have a safe, effective vaccine as soon as the end of this year,” Health and Human Services Secretary Alex Azar said. “Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of this vaccine to the American people.”
Just last week, the FDA fast tracked 2 of the companies' COVID-19 vaccines. The BNT162b1 and BNT162b2 are the investigational vaccines that were given the go-ahead.
“We made the early decision to begin clinical work and large-scale manufacturing at our own risk to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted,” Pfizer Chairman and CEO Albert Bourla said.
“We are honored to be a part of this effort to provide Americans access to protection from this deadly virus.”
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The OraRisk test works by extracting and purifying nucleic acid from SARS-CoV-2 in respiratory samples collected in universal transport media and nasal swabs collected in oral saline rinse. The EUA was granted to OralDNA Labs, an accredited high-complexity laboratory.
"The vast majority of our tests are resulted in less than 24 hours from receipt of sample, and well within our 1-2 business day turnaround time. We are serving the needs of healthcare professionals and patients across the US to help ensure essential services can be provided,” said George Hoedeman, CEO of OralDNA Labs.
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