#425: FDA Approval Of Guardant Health’s Shield™ Liquid Biopsy Could Transform Cancer Screening, & More

Last week, the U.S. Food and Drug Administration (FDA) approved¹ Guardant Health’s Shield™ blood test as a primary screening option for colorectal cancer (CRC) in adults aged 45 and older, marking a pivotal advance in the realm of cancer diagnostics. Aiming to improve CRC screening rates—currently ~59%² in the US—the Shield test offers a convenient alternative to traditional screening methods like colonoscopy. In conjunction with its eligibility for Medicare coverage, the approval of this test is a shift toward more accessible, non-invasive cancer screening methods.

Shield suggests that liquid biopsy technology could revolutionize cancer diagnostics with a simple blood-based test during routine healthcare visits. Traditionally, liquid biopsies have helped in treatment selection and minimal residual disease (MRD) detection. Now, Shield highlights the potential for liquid biopsy to become a standard of care for screening, not only for colorectal cancer (CRC) but also for multi-cancer screening.

At the threshold of early cancer detection, Guardant’s test could become the long-awaited non-invasive and user-friendly option, potentially increasing the odds of successful treatment and survival. Shield highlights not only innovation in medical technology but also the promise of real-time big data in healthcare solutions.

Last week, ARK’s Autonomous Technology & Robotics team tested Tesla’s Full-Self Driving (FSD) v12.5 software in a hands-free drive across both surface streets and highways in St. Petersburg, Florida. We intervened only once when the vehicle had difficulty parking in a lot. In our view, the drive was much smoother than would be likely with an inexperienced driver at the helm.

As noted³ in ARK Disrupt last week, FSD v12.5 has yet to integrate highway and city driving software stacks into an end-to-end solution. That integration should enhance not only performance but also Tesla’s ability to understand how performance scales with computing power. Elon Musk has suggested that upcoming software updates in August will double the performance of FSD compared to the current version.⁴ We look forward to monitoring the improvement of FSD and covering Tesla’s robotaxi event on October 10th.

During the Bitcoin Nashville conference on July 27, Wyoming Senator Cynthia Lummis introduced the BITCOIN Act of 2024—Boosting Innovation, Technology, and Competitiveness Through Optimized Investment Nationwide Act of 2024—proposing a Bitcoin Purchase Program for a Strategic Bitcoin Reserve that could position the United States as a pioneer incorporating digital assets into its national reserves strategy.⁵

The bill proposes that the ~200,000 bitcoins confiscated by the US government after the Silk Road and Bitfinex hacks anchor bitcoin’s position in the US Treasury reserves. The Treasury Secretary will coordinate and oversee the storage of bitcoin across various facilities in the US, while the Secretaries of Defense and Homeland Security coordinate auditing and accounting. The bill also proposes the purchase of an additional ~200,000 bitcoin per year over five years.

The BITCOIN Act stipulates that all bitcoins acquired through the program be held in the Strategic Bitcoin Reserve for at least 20 years, unless they are activated to pay down the national debt, after which time only 10% of the reserves can be recommended to be sold every two years. The Act also stipulates that the reserve will take a neutral stance toward any bitcoin fork or airdrop.⁶

Importantly, the Treasury Secretary must have control over the private keys associated with the reserve, must provide proof of reserves through public cryptographic attestation, and must engage a third-party auditor to verify the reserves. The bill also introduces provisions for voluntary state participation under segregated accounts.

To offset the costs of the Bitcoin Purchase Program, the bill proposes the issuance of new certificates for the current gold reserves in the Fed’s monetary base, adjusting their valuation from the ~$42 per ounce on the books to ~$2,400 at fair market value. Finally, the BITCOIN Act prohibits the Federal government from confiscating bitcoin from individuals.

By establishing a Strategic Bitcoin Reserve, the BITCOIN Act of 2024 could bolster innovation in the United States and accelerate the adoption of bitcoin across nation-states.

According to their latest earnings reports, major AI enablers are boosting infrastructure spending plans. During their earnings conference calls, Microsoft,⁷ Amazon,⁸ and Meta⁹ all projected higher CapEx for data centers and graphics processing units (GPUs) to support robust AI training and inference growth.

Several companies stated that current demand for AI infrastructure is higher than supply, even though their revenue growth rates are decelerating. At Amazon, growth in AWS revenue accelerated from 13% on a year-over-year basis in the first quarter to 19% last quarter, but weak consumer spending pushed overall revenue growth down from 13% to 10%.¹⁰ At Microsoft, the AI contribution to Azure's revenue growth increased from 7 to 8 percentage points, while overall revenue growth decelerated from 17% to 15%.¹¹ Moreover, guidance for the third quarter suggested continued deceleration in total revenue growth for both companies. Based on their stocks’ negative reaction, the deceleration in company-level revenue growth is raising the question of whether AI will generate enough revenue to justify increasingly large investments.

In the face of that uncertainty, CEOs like Mark Zuckerberg are betting that the risk of underinvesting far outweighs the risk of overinvesting. AI already powers recommendation models on Reels, AI-wearables like Meta and Ray-Ban Smart Glasses, and chatbots on Instagram and WhatsApp. Even though their monetization is likely to lag, rapid consumer engagement with those products has emboldened Meta to invest in 600,000 H100s and H100-equivalent GPUs by year-end. Although AI revenues may not lead to an acceleration in total revenue growth in the short-term for companies like Meta, Microsoft, and Amazon, in our view, dialing down infrastructure spending at this early stage of the AI revolution would be a strategic mistake.

Recent research by scientists from MIT underscores¹² the power of single-cell genomics to unravel the mysteries of Alzheimer’s disease. With single-nucleus RNA sequencing machines from 10x Genomics, the researchers analyzed gene expression across ~1.3 million cells from 48 donors, 26 of whom had Alzheimer's, and examined more than 70 cell types in six brain regions.

Although all brain cells share the same DNA, their functions and identities differ according to the specific genes they express. By comparing gene expression across individuals with and without Alzheimer's, the study offered a comprehensive view of how brain cell activity varies by cell type, brain region, and disease pathology, all in relation to an assessment of each person’s cognitive dynamics. Unlike early studies that focused on amyloid protein aggregates, this research identified specific neurons and circuits that are susceptible to Alzheimer’s. Notably, the individuals with Alzheimer’s presented with significant depletions in certain excitatory neurons in the hippocampus and entorhinal cortex. Those neurons are interconnected and linked to a protein called Reelin, which has been associated with cognitive resilience.

Single-cell RNA profiling acts like a sophisticated "microscope," revealing thousands of subtle, yet critical, biological changes in cells, as opposed to the amyloid plaques and tau tangles that Alois Alzheimer observed over a century ago. The advanced technique enables researchers to connect cellular changes to cognitive decline, or resilience, suggesting potential pathways for therapeutic intervention. Notably, the scientist in this study additionally found that astrocytes with enhanced antioxidant activity and choline metabolism were linked to cognitive resilience, despite disease pathology.