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# The FDA Wants to Cut a $636,732 Toll on Cancer Tests. An Incumbent Asked First.
- URL: https://www.freemarketsreport.com/the-fda-wants-to-cut-a-636732-toll-on-cancer-tests-an-incumbent-asked-first/
- Published: 2026-11-14T16:15:11.000Z
- Updated: 2026-11-14T16:15:11.000Z
- Description: Tissue tests that gate cancer drugs have sat in the FDA's hardest class since 1998. The agency wants them out, and its own safety count backs it.
- Author: Michael A. Gayed, CFA
- Tags: Healthcare & Medical Devices

**For 28 years, every tissue test that decides whether a cancer patient gets a targeted drug has gone through the FDA's hardest review, the one built for heart valves and implants. On Thursday the agency proposed to end that.**[**1**](#fn-1) **The filing fee alone would drop from $636,732 to $28,653\. I think it's the right call, and I'll show you why with the FDA's own safety count. But read page 72830 first. One of the two companies that own this market asked for it.**

![Bar chart of fiscal 2027 FDA device fees showing a premarket approval application at 636,732 dollars against 28,653 dollars for a 510(k) notification](https://storage.ghost.io/c/be/1b/be1bb8f3-f534-4eb9-b00d-09ff49598e5f/content/images/size/w1000/2026/11/chart1_fees.png)

## Key Highlights

- **The move:** Immunohistochemistry tests used with an approved cancer drug, 12 product codes in all, would go from class III (premarket approval) to class II (special controls plus a 510(k) notification). Comments are due Jan. 11, 2027.[2](#fn-2)
- **The toll:** A premarket approval application costs $636,732 in fiscal 2027\. A 510(k) costs $28,653, which is 4.5% of that. Class III products also owe a $22,286 annual reporting fee.[3](#fn-3)
- **The record:** Since the first approval in 1998, the FDA has approved 22 original applications and about 270 supplements for these tests. Its adverse-event database holds 48 reports. There has never been a class I recall.[4](#fn-4)
- **The petition:** Ventana Medical Systems asked the FDA on Jan. 7, 2026 to move PD-L1 tests to class II. The agency went further on its own and covered every cancer-drug tissue test of this kind.[5](#fn-5)
- **The clock:** The last reclassification in this series took 432 days from proposal to final order. The FDA says it wants the whole program finished by November 2027.[6](#fn-6)

## What the FDA Proposed

Start with what the test is. A pathologist takes a slice of tumor, stains it with an antibody, and looks for a protein. If the protein is there, a drug may work. If it isn't, the drug may be a waste of months the patient doesn't have. HER2 for breast cancer. PD-L1 for immunotherapy. ALK for lung cancer. The technique is called immunohistochemistry, and the first one tied to a drug, the Dako HercepTest, was approved on Sept. 25, 1998.[7](#fn-7)

That test went into class III because of how the law works, and nobody at the FDA weighed its risk first. Any device type that wasn't on the market before May 28, 1976 lands in class III automatically and stays there until the agency moves it.[8](#fn-8) Nobody moved it. So for 28 years a stain on a glass slide has shared a regulatory lane with implants.

The proposed order creates a new regulation, 21 CFR 864.1895, and puts all of these tests in class II. That covers true companion diagnostics, the ones a drug label requires, and the tests a label merely references. New entrants would file a 510(k). Tests already approved would move over automatically. The FDA proposes that a final order take effect 30 days after it is published.[9](#fn-9) Trade coverage read it the same way[10](#fn-10), and one health-policy newsletter led its edition with it.[11](#fn-11)

That is the surface. The surface is incomplete.

## The Quiet Part: Who Asked

Buried in the regulatory history is one sentence about a petition. After the FDA said it meant to reclassify tests like these, Ventana Medical Systems filed on Jan. 7, 2026 and asked the agency to move every PD-L1 tissue assay from class III to class II.[12](#fn-12) Ventana is Roche's tissue diagnostics unit.[13](#fn-13)

Think about how odd that is. Premarket approval is a moat. It costs a fortune, it takes years of work with a drug company, and it keeps small rivals out. Incumbents usually defend moats like that with lawyers. This one asked for the drawbridge to come down.

I counted the files. The FDA built its case on 14 old approval applications, the ones more than six years old that the law lets it use. Six carry the Dako name or its pharmDx brand, which is Agilent. Six are Ventana. One is BioGenex and one is the Bond Oracle HER2 system.[14](#fn-14) Two companies wrote 12 of the 14\. This market was never crowded.

So why would an owner of half the moat want it gone? Here's my read, and it is a read, because Ventana's petition isn't quoted in the order. The moat was costing more than it kept out. Those 22 approvals came with about 270 supplements.[15](#fn-15) That is roughly a dozen follow-on filings for every test. Add a tumor type or move the test to a new instrument, and you generally go back to the agency. Under class II, a company can file a predetermined change control plan once and make the changes it described without a new submission each time.[16](#fn-16)

The paperwork was a tax on the incumbents too. They just happened to be the only ones rich enough to pay it.

## The Numbers

The fee gap is the easy part. $636,732 against $28,653, a ratio of about 22 to 1, and a small company pays $7,163 for a 510(k).[17](#fn-17) Fees are the smallest piece of the cost, though. Time is the bigger one. The FDA's goal for an original approval application is a decision within 180 FDA days. For a 510(k) it is 90.[18](#fn-18) Counting the days a file sits with the company, the shared target by the end of the current fee program is 285 calendar days for approvals and 112 for 510(k)s.[19](#fn-19)

Now the safety count, because that's where this argument is won or lost. In 28 years the FDA's database logged 48 adverse-event reports across all of these tests. Thirty-five involve PD-L1\. More than 70% said there was no known harm to the patient. The agency found 11 recalls: ten class II, one class III, and no class I, the category for a reasonable chance of serious harm or death.[20](#fn-20)

![Table of the FDA safety record for cancer-drug tissue tests since 1998 showing 22 approvals, about 270 supplements, 48 adverse event reports and no class I recalls](https://storage.ghost.io/c/be/1b/be1bb8f3-f534-4eb9-b00d-09ff49598e5f/content/images/size/w1000/2026/11/chart2_record.png)

One detail deserves your attention. Twenty-nine of those 48 reports trace to a single 2023 recall over light staining that could produce a false negative. That recall is still open.[21](#fn-21) Strip it out and you have 19 reports in 28 years.

Nineteen. In 28 years.

I can't give you a failure rate, to be fair. The order doesn't publish how many slides get stained, so I won't pretend to one. What I can say is that the agency looked at everything it had and found no pattern that the hardest review prevents and a lighter one would miss.

## Who Wins, Who Loses

Challengers win first. The proposed special controls say a new test can show clinical performance with data from the drug's own trial or with "a method comparison study to an appropriate FDA-authorized device".[22](#fn-22) Read that twice if you make antibodies. You no longer have to be the test that was in the drug trial. You have to prove you match the one that was.

Labs win second. Today a hospital lab that wants to run the labeled test for each immunotherapy may need different kits, and sometimes different instruments, for different drugs. If more makers can clear a claim on the stainer a lab already owns, the lab gets to pick on price and workflow. That is what a market looks like.

Drug companies win quietly. A targeted drug can't launch without its test. A test partner that can clear in a 90-day lane instead of a 180-day one is one less thing that can slip.

Who loses? Anyone whose business depended on being the only approved option. And here the honest answer is the same two names. Agilent and Roche get lighter paperwork and more competitors in one stroke. Which effect is bigger is the whole investment question, and I'll get to it.

## The Free-Market Read

Let me give the other side its due. A companion test is the gate to a drug. A false negative means a patient who could have responded never gets the therapy. A false positive means months on a drug that won't work, with the side effects and the bill. The FDA itself says false negatives are the most common problem in the reports it does have. If you believe the strictest review is why the record is clean, then loosening it looks like spending down a safety margin to save companies money.

I take that seriously. I don't think it holds. Class II still means regulation. The proposed controls require analytical data on precision and specificity, clinical performance data, cut-off criteria, and labeling that tells the pathologist what the test can and can't do.[23](#fn-23) The agency is saying that after 28 years it knows what to check, so it can write the checklist down instead of reinventing it one application at a time. Written rules that anyone can meet beat a bespoke negotiation only giants can afford.

Here's what I keep coming back to. A rule that prices out entrants doesn't make a product safer. It makes it scarcer. Twelve of 14 files from two companies, in a field that decides who gets a cancer drug, is what a toll booth produces. I'd rather have five makers competing to stain a slide well than two protected by a filing fee.

And notice the part that should make you smile. The FDA used the incumbents' own old applications as its evidence. The data they paid to generate is now the public standard that lets rivals in. The six-year rule did what patents are supposed to do: reward the first mover for a while, then hand the knowledge to everyone.

I've written about this pattern before. It is the same thing that happened in [The Device That Invented 3D Mammography Just Lost Its Regulatory Moat](https://www.freemarketsreport.com/the-device-that-invented-3d-mammography-just-lost-its-regulatory-moat/). Once a technology is understood, class III stops protecting patients and starts protecting market share.

## What Could Go Wrong

Three things. First, this is a proposal. The comment window runs to Jan. 11, 2027, and the last order in this series, for in situ hybridization tests, was proposed on June 11, 2025[24](#fn-24) and finalized on Aug. 17, 2026.[25](#fn-25) That is 432 days. Run the same clock from Thursday and you land on Jan. 18, 2028, two months past the FDA's own November 2027 goal. The sister proposal for nucleic acid tests has been pending since Nov. 25, 2025.[26](#fn-26)

Second, the evidence is older than the products. The FDA relied on applications approved before Oct. 15, 2020, from five of the 12 product codes.[27](#fn-27) The other seven codes, the newer biomarkers, ride along on the argument that the technology is the same. I think that's reasonable. A comment letter from a cancer center could argue it isn't.

Third, the open recall. A light-staining problem that generated 29 reports in one year is exactly the failure a method-comparison pathway has to catch. If the final special controls go soft on lot-to-lot consistency, I'd change my mind about the safety case.

## The Idea

The idea is Agilent Technologies (A). It makes the Dako line: HercepTest, the first of these tests ever approved, and PD-L1 IHC 22C3 pharmDx, which it lists under a collaboration agreement with Merck.[28](#fn-28) Agilent sells its companion tests under the pharmDx brand.[29](#fn-29) Its annual report says it partners with "several major pharmaceutical companies" on new ones, from pre-clinical work through launch.[30](#fn-30)

I know the objection. I just told you the incumbents lose their moat, and Agilent is half the incumbency. So why own it?

Because I don't think the approval file was ever the real moat. The real one is being in the room when a drug company designs its trial. The proposed controls still treat the trial's enrollment test as the gold standard that everyone else gets compared against. Agilent says it has more than 20 companion diagnostic programs in development.[31](#fn-31) Under today's rules each one that reaches the FDA is a $636,732 filing with a 180-day goal, followed by a string of supplements. Under the proposal each is a $28,653 filing with a 90-day goal and a change plan. The pipeline gets cheaper and faster, and the installed tests shed their annual class III fees.

![Bar chart of Agilent Life Sciences and Diagnostics Markets segment revenue for five quarters, rising from 670 million dollars in fiscal third quarter 2025 to 746 million in fiscal third quarter 2026](https://storage.ghost.io/c/be/1b/be1bb8f3-f534-4eb9-b00d-09ff49598e5f/content/images/size/w1000/2026/11/chart3_agilent.png)

The segment that holds pathology is already Agilent's fastest mover. Life Sciences and Diagnostics Markets revenue was $746 million in the quarter ended July 31, up 11.3% from $670 million a year earlier, against 8.1% growth for the company. Segment operating income rose to $176 million from $118 million.[32](#fn-32) What I think the market is missing is the sequence. In situ hybridization tests moved to class II on Sept. 16\. Nucleic acid tests are proposed. Tissue stains are now proposed. Agilent sells into the first and third. Nobody is going to model a fee table. But lighter filings across a 20-program pipeline add up.

Now the risks, and they're real. Agilent doesn't break out pathology, so you're buying a $49 billion company to get a slice of one segment. The stock closed Friday at $173.96, up 18.4% in a year against 12.3% for the S&P 500 ETF, about 5% under its 52-week high and at 34 times trailing earnings.[33](#fn-33) That isn't cheap. And the copycat risk cuts straight at 22C3: if a rival clears a matching PD-L1 claim by method comparison, labs could run it on equipment Agilent didn't sell them.

I'm wrong if the final order adds controls heavy enough to erase the time savings, or if the segment's growth falls below the company's for two straight quarters after a rival test clears. I keep score on every idea [here, winners and losers](https://www.freemarketsreport.com/idea-scorecard/).

## What To Watch Next

Jan. 11, 2027 is the date. Watch who files comments and what they ask for. If Agilent and Roche both support the order, you'll know the incumbents have decided the paperwork cost them more than the protection was worth. If either asks for tougher method-comparison rules, that's the moat being rebuilt in the fine print, and I'll say so. I've added the deadline to the [Deregulation Investor's Catalyst Calendar](https://www.freemarketsreport.com/the-deregulation-investors-catalyst-calendar/).

Watch the nucleic acid order too. It has been pending almost a year, and it is the bigger prize for sequencing-based tests. Health regulators have been retreating in pieces all autumn, as I laid out in [HHS Cut 14 Health IT Rules, Not 34](https://www.freemarketsreport.com/hhs-cut-14-health-it-rules-not-34-the-retreat-is-the-signal/), and the pieces don't always arrive on schedule.

A stain on a slide spent 28 years in the same lane as a heart valve. The FDA finally asked why. The next question is how many other products are still parked there for no better reason than the year they were invented.

Know someone who should be reading this?

One deregulation story and one stock idea, every day, free. Send it to someone who thinks markets work better than mandates.

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## Sources

1. [FDA proposed order, Reclassification of Immunohistochemistry Test Systems, 91 FR 72825](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
2. [FDA proposed order, summary and dates](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
3. [FDA, Medical Device User Fee Rates for Fiscal Year 2027, Table 5](https://www.federalregister.gov/documents/2026/07/30/2026-15335/medical-device-user-fee-rates-for-fiscal-year-2027?ref=freemarketsreport.com) (federalregister.gov)
4. [FDA proposed order, section II, regulatory history](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
5. [FDA proposed order, docket FDA-2026-P-1301 discussion](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
6. [FDA, laboratory developed tests FAQ, reclassification timeline](https://www.fda.gov/medical-devices/laboratory-developed-tests-faqs/specific-test-categories-or-technologies-laboratory-developed-tests-faqs?ref=freemarketsreport.com) (fda.gov)
7. [FDA proposed order, first approval, P980018](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
8. [FDA proposed order, section I, section 513(f)(1) of the FD&C Act](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
9. [FDA proposed order, sections IV and X](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
10. [The Script Pad, FDA proposes moving oncology IHC companion tests to 510(k)](https://thescriptpad.com/articles/fda-proposes-reclassify-oncology-ihc-companion-diagnostics-class-ii-510k-pd-l1-her2?ref=freemarketsreport.com) (thescriptpad.com)
11. [American Health Intel, The Regulator, Nov. 11, 2026](https://americanhealthintel.com/editions/2026-11-11-regulator/?ref=freemarketsreport.com) (americanhealthintel.com)
12. [FDA proposed order, Ventana petition, docket FDA-2026-P-1301](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
13. [The Script Pad, on the Ventana petition](https://thescriptpad.com/articles/fda-proposes-reclassify-oncology-ihc-companion-diagnostics-class-ii-510k-pd-l1-her2?ref=freemarketsreport.com) (thescriptpad.com)
14. [FDA proposed order, list of 14 original PMAs relied on](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
15. [FDA proposed order, count of PMAs and supplements](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
16. [FDA proposed order, predetermined change control plans](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
17. [FDA, fiscal 2027 fee table, standard and small business fees](https://www.federalregister.gov/documents/2026/07/30/2026-15335/medical-device-user-fee-rates-for-fiscal-year-2027?ref=freemarketsreport.com) (federalregister.gov)
18. [FDA, MDUFA V performance goals, PMA and 510(k) decision goals](https://www.fda.gov/media/157074/download?ref=freemarketsreport.com) (fda.gov)
19. [FDA webinar transcript, total time to decision goals, Oct. 24, 2024](https://www.fda.gov/media/183184/download?ref=freemarketsreport.com) (fda.gov)
20. [FDA proposed order, MAUDE and recall data as of July 15, 2026](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
21. [FDA proposed order, 2023 class II recall](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
22. [FDA proposed order, section VII, proposed special controls](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
23. [FDA proposed order, Table 1, risks and mitigation measures](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
24. [FDA proposed order on ISH test systems, 90 FR 24540](https://www.federalregister.gov/documents/2025/06/11/2025-10549/hematology-and-pathology-devices-reclassification-of-in-situ-hybridization-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
25. [FDA final order on ISH test systems, 91 FR 53184](https://www.federalregister.gov/documents/2026/08/17/2026-16727/hematology-and-pathology-devices-reclassification-of-in-situ-hybridization-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
26. [FDA proposed order on nucleic acid-based test systems, 90 FR 53261](https://www.federalregister.gov/documents/2025/11/25/2025-21071/immunology-and-microbiology-devices-reclassification-of-nucleic-acid-based-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
27. [FDA proposed order, footnote 7 and section II](https://www.federalregister.gov/documents/2026/11/12/2026-23005/hematology-and-pathology-devices-reclassification-of-immunohistochemistry-test-systems-for-use-with?ref=freemarketsreport.com) (federalregister.gov)
28. [Agilent, AACR 2026 pathology and companion diagnostics presentation](https://www.agilent.com/content/dam/about/newsroom/media-room/aacr-2026/aacr%5F2026%5Fpresentation.pdf?ref=freemarketsreport.com) (agilent.com)
29. [Agilent, companion diagnostics for laboratories](https://www.agilent.com/en/solutions/companion-diagnostics/laboratory?ref=freemarketsreport.com) (agilent.com)
30. [Agilent Form 10-K for fiscal 2025, companion diagnostics](https://www.sec.gov/Archives/edgar/data/1090872/000109087225000087/a-20251031.htm?ref=freemarketsreport.com) (sec.gov)
31. [Agilent, AACR 2026 presentation, current CDx development programs](https://www.agilent.com/content/dam/about/newsroom/media-room/aacr-2026/aacr%5F2026%5Fpresentation.pdf?ref=freemarketsreport.com) (agilent.com)
32. [Perplexity Finance, Agilent segment and income statement data, fiscal Q3 2026](https://www.perplexity.ai/finance/A?ref=freemarketsreport.com) (perplexity.ai)
33. [Perplexity Finance, A quote and price history, Nov. 13, 2026](https://www.perplexity.ai/finance/A?ref=freemarketsreport.com) (perplexity.ai)