This Cancer Detection Pioneer Is Absolutely Worth Your Attention Right Now

Cancer detection breakthrough sends shockwaves through medical industry—while Wall Street analysts scramble to update their spreadsheets.

Revolutionary Diagnostics

The technology cuts through traditional diagnostic limitations, bypassing months of testing delays with precision that makes conventional methods look medieval. Early detection rates soar while false positives plummet—numbers that actually matter unlike most quarterly earnings reports.

Market Disruption Ahead

Hospitals adopt the system faster than traders chasing crypto pumps. Clinical validation studies show performance metrics that would make even the most cynical FDA reviewer nod approvingly. The science delivers what fintech promises but rarely achieves: actual measurable improvement in human outcomes.

Investment Implications

While traditional healthcare stocks wobble, this pioneer demonstrates that real innovation still happens outside boardrooms—a concept apparently foreign to most legacy financial institutions still debating blockchain relevance. The technology doesn't just detect cancer early; it exposes how outdated the entire medical investment thesis has become.

A single test

Wouldn't it be great if there existed a single test for dozens of the most prevalent types of cancer?

Well, that's exactly what(GRAL 0.68%) makes. Its multicancer early detection (MCED) test -- called Galleri -- screens for a signal in the blood shared by more than 50 types of cancer. Cancers growing in the human body shed their DNA into the bloodstream, and the Galleri test can detect that DNA very early on.

Image source: Getty Images.

So it's no wonder the Galleri test is catching on. Grail has sold 370,000 Galleri tests so far, including 45,000 in the second quarter of this year. Revenue ROSE 35% last year to $126 million. And sales were up 21% in Q2 to $34.2 million. The company has more than $600 million cash on hand.

But Grail is not yet profitable -- a common trait among biotech start-ups. It posted a net loss of $114 million last quarter, and it expects to burn $310 million in cash this year on further research, testing and marketing.

Awaiting FDA approval

Furthermore, Grail's test is not yet FDA approved, so it can't be covered by insurance, which severely limits its appeal to buyers and its overall sales. The company is currently working toward FDA approval as well as the ability to be covered by Medicare, the largest payer for healthcare in the U.S. More test results are required to achieve those lofty goals, and the company expects to submit for FDA premarket approval in the first half of 2026.

Because the company continues to post losses, some analysts have questioned its $1.6 billion market capitalization. Further adding to concern is the fact that if Grail submits for FDA approval in the first half of next year, it's unlikely to get that approval until 2027. Or it may never get FDA approval.

Despite all this, Grail stock has been popular among investors this year. The share price is up 146% year to date and it has more than tripled over the past 52 weeks.

Somewhat speculative

Sales of Galleri can't really gain scale until the FDA grants approval to the test, which is not guaranteed. And there are competitors in the cancer testing space, including, which makes the well-known Cologuard test for colorectal cancer and sells its own multicancer early detection test called Cancerguard. That test can detect a smaller number of cancers than Galleri and is also not yet approved by the FDA.

People do pay for those tests out of pocket, about $700 for Cancerguard or $950 for Galleri.

Clearly, Grail is a somewhat speculative stock due to competition and the uncertainty of federal approval. But if Grail does get FDA approval and Medicare coverage approval, the sky could be the limit.