New FDA Regulations Could Stop Innovative Test Development for Lyme Disease

New FDA Regulations Could Stop Innovative Test Development for Lyme Disease

The FDA wants to move forward with regulations to restrict cutting edge laboratory developed tests (LDTs), which have not required FDA approval before, requiring FDA approval for all LDTs and effectively blocking critical innovation. 

Why would the FDA should restrict any  cutting edge lab test when the medical marketplace will drive the success of any test based on its success rate?  In this case the restrictions are very far reaching.

In fact, it would set back the likelihood of any new diagnostic test for Lyme disease becoming available for the foreseeable future.

A letter was sent in July by five US Senators to the White House Office of Management and Budget in support of new FDA regulations (just announced) that would set back all progress made towards helping change the two-tier test for diagnosing Lyme disease. (Although “Lyme disease” is not mentioned by name, the connection is obvious when the request states it would require FDA approval for any test that would require “unnecessary antibiotic treatment”.)

Particularly disturbing is the signature of Sen. Blumenthal (who won his election with quite a bit of help from Lyme activists and the thousands of those personally affected by Lyme who voted for him due to his very public political stand against the IDSA guidelines for diagnosing Lyme back in 2006.) The other four are Sen. Edward Markey D-MA; Sen. Elizabeth Warren D-MA; Sen. Sherrod Brown D-OH; and Sen. Richard Durbin D-IL (see letter here:

If these regulations are instituted, then we will be stuck with the current two-tiered Lyme diagnosis guidelines set forth by the IDSA for many years as there are so few companies that have over 100 million dollars (and political clout) to get their products approved by the FDA.

The test developed by Advanced Laboratory Services that boasts a 94% success rate as opposed to the ELISA which boasts a 40% – 70% (actual figures are anyone’s guess because without an accurate test to compare the results it is all open to debate, and there have not been any comparative tests done as of yet.)

In fact, a test like the blood culture used by Advanced Lab Services is not even approved in New York due to politics.  Officially it is denied due to acceptable verification. And yet each test is verified by DNA. Huh?

These new regulations have been requested repeatedly since 2006 by the White House Office of Management and Budget due to fierce opposition.

According to a recent New York Times article: 

The agency (FDA) said the playing field was unbalanced. Some companies that have done the clinical studies to win F.D.A. approval are competing against very similar tests that get to market without such studies and oversight. The new plan would regulate tests based on their use, not how they were developed, the F.D.A. said.”

Interestingly one would think that the Republicans would stand behind big business but in this case the Democrats are standing behind this new regulation and Republicans are opposing it.  Read:

The article also reveals a letter sent by 23 laboratory directors and pathologists, from academic medical centers like those at Harvard, Duke and the University of Utah, wrote in a letter to the Obama administration who remain at the heart off research and development to bring relief to the sufferers of Lyme disease:

“The ability of laboratories to develop custom diagnostic tests has been critical to the growth of personalized medicine and keeping pace with the changing face of disease,” Read letter here:

The labs also dispute that the agency even has jurisdiction. They say that testing is a service, not a medical device.”

Medical testing is already under the jurisdiction of Centers for Medicare and Medicaid Services.

 Read New York Time article here:

Lorraine Johnson, Executive Director for wrote in a recent blog post:

“The IDSA guidelines require a positive blood test to confirm the presence of Lyme. Since lousy lab tests so rarely deliver the right diagnosis, insurers rely on these IDSA guidelines to deny care and prevent patients from getting the treatments they need. 

“Lyme patients have been railing against the poor quality of Lyme tests for years. So why aren’t better tests on the market? Blame the vested lab interests that currently control FDA Lyme testing. Among the 28 companies with FDA approved tests, at least 25% have ties to the key IDSA researchers who developed the IDSA Lyme guidelines. Drs. Gary Wormser, Raymond Dattwyler, and Alan Steere, have disclosed industry ties with at least nine companies who are involved with Lyme diagnostic tests:Biomerieux, Bio-Rad, Biopeptides, DiaSorin, Abbott, Baxter, Chembio, Immunetics, and Viramed.

A CDC study in 2008 found that over four million Lyme lab tests are performed annually at an estimated cost of $500 million. This is not chump change and in this fight, concern for patients is not even on the agenda. It’s time to recognize anti-competitive acts for what they are. The proposed regulations enrich vested lab interests at the expense of patients.  Read more at:

It is hard not to feel angry when big business, government and personal greed get in the way of compassionate medical care.  What ever happened to the hippocratic oath?


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4 Responses to New FDA Regulations Could Stop Innovative Test Development for Lyme Disease

  1. Marlyn R says:

    I was lucky. I had enough bulls eyes to be an archery target. 3 weeks on Doxy. Overall good….however… I went online to learn what to look for after CDC recommended treatment. I was somewhat aware of the lack of follow-up information out there, but I was horrified to see this. I have an autoimmune thyroid disease, and RA. A definitive test is essential for people like me. As with many autoimmune illnesses, diagnosis is difficult…..NOW I READ THAT IT’S MY GOVERNMENT THAT’S HOLDING IT BACK, BY ANY $$ MEANS NECESSARY. I wish I could say I was speechless.

    • Jenna Smith says:

      I will be keeping readers aware of any action that can be taken. Obviously writing US Senators and Congressman will help – this has been successfully blocked in the past but we need legislation to expand research, protect LLMDs and change 2 tiered test currently recommended by IDSA. Governments involvement is the only way to eliminate the power grab at IDSA and force CDC to do their job and protect US citizens from this horrendous epidemic. You may not be as lucky as you think if you didn’t have RA before your rash, you may not have had enough abx (antibiotics) after the rash. Unfortunately 3 weeks is not enough for some of the virulent strains (I say this with confidence based on the many emails I receive from angry people who were treated after getting the rash and went on to be chronically ill due to weak treatment. Lyme can also mimic Thyroid disease – hopefully you had these ailments BEFORE getting bitten by the tick.


      • Marlyn R says:

        Thank you for your reply. My thyroid disease was diagnosed @ 17 years old, and RA when I was 35. I’m now 60. It’s because of that, that I’ve been looking for a follow-up after doxy. I’d like to be aware of Lyme after immediate diagnosis & doxy. So far so good, however I never know what the future holds.
        Regards, Marlyn

        • Jenna Smith says:

          Marilyn – make sure you take Lumbrokinase to combat biofilms or you will just relapse after the antibiotics – especially if you have been infected for that many years. Best wishes!

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