Our first topics for this issue are the continuing major developments in COVID-19 testing and vaccines. On the testing front, the FDA has approved the first at-home COVID-19 diagnostic. This development is especially welcome given the rising number of cases nationwide, and the likelihood of further increases as winter intensifies.
FDA Clears First Rapid At-Home COVID Test
Lucira Health’s prescription COVID-19 All-In-One Test Kit can be performed entirely at home or in point-of-care settings, with results in 30 minutes or less.
Previously, the only FDA-approved alternative to centralized testing involved at-home collection of samples to be mailed in. Lucira’s newly approved at-home test is quite intriguing and attractive. With an anticipated retail cost of roughly $50, the test produces clinical-grade accuracy within 30 minutes.
To achieve accurate test results from a small fluid sample, the testing process must amplify the viral material to the point where it is easily detectable. Lucira’s test uses a technology known as loop-mediated DNA amplification, which allows the entire process to take place at one temperature. By contrast, lab instruments require the sample to be shifted rapidly among very different temperatures.
Due to limited supply, the Lucira test is restricted by prescription to users who most urgently need fast results. So, we do not expect this product to alleviate testing shortage issues in the very short term. However, given the rapid pace of developments in this space, we may see additional progress and availability this season.
COVID vaccine news has been auspicious lately. Both Pfizer and Moderna have claimed strong efficacy results for their vaccine candidates (roughly 95% in each case) and have submitted to the FDA for Emergency Use Authorization. These vaccines have been produced in quantity and are already being shipped in anticipation of FDA approval.
AstraZeneca, the other pharmaceutical company with a vaccine candidate in Phase III trials, reported less impressive results. AstraZeneca reported that its vaccine had roughly 70% effectiveness. Besides, AstraZeneca reached that number using data from groups with different dosing (apparently due to error) and multiple geographies. AstraZeneca’s report has significantly reduced confidence in this particular vaccine, prompting the company to run additional clinical studies.
AstraZeneca Will Do More Testing of COVID Vaccine, CEO Says
‘Now that we’ve found what looks like a better efficacy, we have to validate this, so we need to do an additional study,’ CEO Pascal Soriot said.
Even at a lower efficacy than the Pfizer and Moderna vaccines, AstraZeneca’s vaccine could play a key role in the early stages of mass vaccination. Unlike Pfizer and Moderna’s mRNA vaccines, AstraZeneca’s vaccine is made using more standard methods. Therefore, it can be produced at a much lower cost, and it does not require the same icy supply chain that both Pfizer and Moderna’s vaccines do. In certain areas of the world, those differences may render AstraZeneca’s vaccine the more practical option.
In Other News
We have previously explored how and why there is no established early-detection method for Alzheimer’s in other news. Imaging methods show substantial promise, and now there is promising research on a blood test that uses certain specific amyloids as biomarkers.
Blood Test May One Day Predict Alzheimer’s With Up to 89% Accuracy
Experts were generally enthused by the result, with one describing it as a “potential game-changer.”
Amyloids are proteins that accumulate in Alzheimer’s patients’ brains and are good early indicators of the disease. However, those amyloids have proven difficult to detect in circulating blood. This new test has overcome that hurdle and may detect early Alzheimer’s with nearly 90% accuracy, allowing for the at-risk population’s mass screening. Once a subject tests positive, imaging can be used to confirm the result and locate which particular portion of the brain is affected.
Relatedly, Grail’s cancer tests are now being trialed by the National Health Service (NHS) in the UK. We have previously talked about Grail’s progress and how we expect it to be reacquired by Ilumina for an estimated $8B soon. This pilot study by the NHS shows how far Grail (and liquid biopsy technologies generally) have progressed.
This major trial will provide a large amount of the Grail technology’s clinical validation to gain UK regulatory approval. Additionally, this pilot study will include several US sites, allowing the data to be used for the FDA’s approval process. For this technology, the final hurdle will be achieving reimbursement from health insurance and Medicare in particular. This process is lengthy and data-intensive, but it is necessary for significant adoption in the US.
NHS to Pilot Grail’s Cancer-Spotting Blood Test in 165,000 Patients
The U.K. National Health Service is looking to get an early start on the international rollout of Grail’s multi-cancer blood test with a pilot program spanning 165,000 people.