This Cancer Detection Pioneer Is Worth a Look

Key Points

• Multicancer screening technologies are advancing rapidly.

• Grail is one of the leaders in the cancer screening space.

• 10 stocks we like better than Grail ›

Despite decades of progress in fighting it, cancer remains deadly. It is the second-leading cause of death in the United States, behind only heart disease.

Early detection and screening are two of the most powerful tools against the disease -- they lead to higher survival rates, less invasive treatments, fewer side effects, and a higher quality of life for cancer patients.

Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best stocks to buy right now. Learn More »

Yet early detection screening tests currently exist for only a few cancers, including breast, cervical, colorectal, prostate, and lung. About 70% of cancers have no recommended screening test.

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 Grail (NASDAQ: GRAL) 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 Exact Sciences, 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.

Should you invest $1,000 in Grail right now?

Before you buy stock in Grail, consider this:

The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Grail wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.

Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $651,593!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,089,215!*

Now, it’s worth noting Stock Advisor’s total average return is 1,058% — a market-crushing outperformance compared to 188% for the S&P 500. Don’t miss out on the latest top 10 list, available when you join Stock Advisor.

See the 10 stocks »

*Stock Advisor returns as of September 22, 2025

Matthew Benjamin has positions in Grail. The Motley Fool recommends Exact Sciences and Grail. The Motley Fool has a disclosure policy.