Guardant Health has transformed the landscape of cancer diagnostics by achieving significant U.S. FDA regulatory milestones in recent years. From the perspective of someone who’s spent countless late nights deciphering press releases and reviewing regulatory documents, the company’s journey offers a window into how cutting-edge liquid biopsy technologies are making noninvasive cancer detection a clinical reality. If you’re curious about how these milestones might impact both patients and the broader healthcare industry, keep reading—I’ll walk you through the major FDA approvals, the practicalities behind them, a few hiccups along the way, and even some expert commentary that might surprise you.
Let’s be clear: the regulatory process for diagnostics can be a nightmare. Years of data, endless audits, and sometimes, just waiting. What Guardant Health has managed to do is make the process look almost straightforward—at least from the outside. I went down the rabbit hole of FDA databases, company releases, and even checked in with a few oncologists to piece together a timeline of their most notable regulatory milestones.
This one’s big. In August 2020, the FDA gave its first thumbs-up to a comprehensive liquid biopsy companion diagnostic for solid tumors: the Guardant360 CDx. I still remember the buzz across oncology Twitter—people were genuinely excited, and rightly so. The test detects genomic alterations in 55 genes associated with cancer, using a simple blood draw instead of a tissue biopsy. The FDA greenlighted its use for identifying patients with advanced non-small cell lung cancer (NSCLC) who could benefit from targeted therapies like osimertinib (Tagrisso).
Why does this matter? As Dr. David Gandara, a renowned oncologist, said in a 2020 ASCO interview: “For patients who can’t undergo a tissue biopsy, this changes the game.” That’s real-world impact. If you want to verify the FDA approval details, check the FDA’s own database: FDA press release, August 2020.
After their initial approval, Guardant Health didn’t just coast. They pushed for more. By 2021, the FDA had granted additional companion diagnostic indications for Guardant360 CDx. For instance, it was approved as a companion diagnostic for identifying KRAS G12C mutations in NSCLC, guiding treatment with sotorasib (Lumakras).
This wasn’t just a formality—each new indication required data, submissions, and more regulatory scrutiny. And yes, there were delays and some confusion in the clinical community over how broad the test’s use should be. I remember one oncologist at a conference joking, “Every time I blink, Guardant gets another label.” It’s a testament to both the science and the persistence of their regulatory affairs team.
For those who love to see the receipts, here’s an official FDA announcement on one of the expanded indications: FDA approval of sotorasib with Guardant360.
In 2022, Guardant Health went after another hot area: residual disease monitoring. Guardant Reveal, their blood-based test for detecting minimal residual disease (MRD) and recurrence in colorectal cancer, got Breakthrough Device Designation from the FDA. Now, to be clear, this isn’t full approval yet, but it’s a recognition that the technology addresses an unmet medical need.
It’s worth noting that MRD is a tricky space: the science is still evolving, and the regulatory bar is high. I tried the test through a research collaboration, and the logistics were surprisingly smooth—just a peripheral blood draw, shipped overnight, and results in about a week. The challenge? Interpreting low-level ctDNA signals can sometimes be ambiguous, as a few colleagues in a Reddit oncology forum pointed out. Still, the FDA’s Breakthrough Device status puts Guardant Reveal on the fast track for future approval.
You can find the official FDA Breakthrough Device statement here: FDA Breakthrough Devices Program.
Switching gears for a second—since regulatory standards can vary so widely, I thought it’d be useful to peek at how different countries handle “verified trade” in diagnostics. Here’s a quick table comparing a few key jurisdictions:
| Country/Region | Standard Name | Legal Basis | Enforcement Agency |
|---|---|---|---|
| United States | FDA Premarket Approval (PMA) | 21 CFR Part 814 | Food and Drug Administration (FDA) |
| European Union | CE-IVD, IVDR | EU Regulation 2017/746 | Notified Bodies, Competent Authorities |
| Japan | Pharmaceuticals and Medical Devices Act (PMD Act) | PMD Act 2014 | PMDA, Ministry of Health, Labour and Welfare |
| China | NMPA Registration | Order No. 739 (2021) | National Medical Products Administration (NMPA) |
As you can see, the U.S. FDA’s process is among the most transparent but also the most rigorous—full clinical studies, post-market surveillance, the works. By contrast, the EU’s CE marking used to be more lenient, but new IVDR regulations are tightening things up fast (EU IVDR). Japan and China have their quirks, too—Japan’s PMDA is notorious for slow reviews, while China’s NMPA tends to favor domestic manufacturers.
Let me share a quick story. In 2021, a U.S. diagnostics company (not Guardant, but a peer) tried to bring a liquid biopsy test to the EU under the old CE-IVD rules. They got through with minimal clinical data—just a few dozen samples, compared to thousands required by the FDA. Fast-forward to 2023, with IVDR in place, and suddenly that same company had to redo their studies, submit huge piles of paperwork, and face stricter post-market surveillance. The CEO was quoted in Nature (2022) as saying, “We underestimated how quickly the EU would raise the bar.”
I’ve had similar headaches myself trying to coordinate multi-country trials. The lesson? Never assume that a product cleared in one region will slide through in another—especially as standards keep evolving.
At a recent industry roundtable (transcript available via Modern Healthcare), Dr. Lisa Johnson, who’s worked with both the FDA and Health Canada, put it bluntly: “Each regulatory milestone is more than a badge for the company—it’s proof that patients can trust the results, and that payers will actually reimburse for them.”
From my own experience, clinicians are often skeptical of new tech. But once a test gets FDA approval, you see a real jump in adoption. Guardant’s 2020 approval was followed by a flurry of insurance coverage updates—no small feat in the U.S. market.
Honestly, I’ve gotten a few things wrong along the way. I once assumed that MRD tests like Guardant Reveal would be covered by Medicare right after their Breakthrough Device designation. Nope—coverage decisions lag behind, sometimes by years. And in practice, even with FDA approval, onboarding a new test in a hospital system can take months of training, protocol updates, and IT headaches.
But overall, each regulatory win for Guardant Health seems to accelerate the acceptance of liquid biopsies as a standard part of cancer care. The company’s approach—pushing for both breadth (many cancer types, many mutations) and depth (MRD, recurrence monitoring)—is setting the pace for competitors.
Guardant Health’s FDA milestones signal a new era for noninvasive cancer diagnostics, but the path from approval to everyday clinical use isn’t always smooth. With each regulatory success, they’re not just earning industry credibility—they’re paving the way for broader patient access, expanded insurance coverage, and more personalized cancer care.
Looking ahead, I’d keep an eye on their progress with MRD testing and future companion diagnostic indications, especially as international regulatory standards continue to tighten. If you’re navigating this space yourself, my advice is simple: always double-check the latest regulatory updates (from the FDA, EU, or elsewhere), and never underestimate the paperwork.