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Serimmune uses next-generation technology to more precisely determine what pathogens a person has been exposed to.

Ever wonder if you’ve been exposed to one of those nasty tick-borne illnesses? How about if you ever came down with the coronavirus? A free study launched by the Santa Barbara-based Serimmune company could provide you with some data on that.

Serimmune was created in 2014 and has received funding from Illumina Ventures, LabCorp, and Merck. It calls itself an “immune intelligence” company.  That’s a pretty good descriptor for a company that uses mounds and mounds of data to decipher what’s going on in our immune systems.

One review reported that its flagship technology called “serum epitope repertoire analysis”, or SERA, is going to do for antibodies what next-generation sequencing can do for genes: quickly and efficiently survey all of them.

Why do that? Because antibodies hold the key to understanding both past and present infections.

The Hunt for Antibodies – and Past Infections

antibodies

Antibodies latch onto a pathogen blocking it from entering a cell and alerting the immune system to its presence. Memory antibodies are also formed that quickly alert the immune system to the pathogen’s presence if it comes around again.

It’s the role antibodies play in the “adaptive immune response” that makes the SERA technology so enticing. The adaptive immune response is called adaptive because during it, B and T-cells learn how to specifically target an infection.

When B-cells come across what they believe to be a pathogen, they rev up their engines and differentiate into either plasma cells or memory B-cells. Plasma cells then start producing massive amounts of antibodies (or immunoglobulins) that specifically target a molecule or antigen on the pathogen (hence the term “adaptive”).

The strategy is pretty straightforward – latch onto a pathogen, marking it for destruction by the immune system – and try to block it from infecting a cell by covering up the infection site. At the same time some B-cells are turning themselves into antibody-producing machines, though, other B-cells are forming themselves into long-lasting memory B-cells that produce antibodies that help the immune system quickly pounce on the invader the next time it shows up.

It’s these memory B-cells, and the antibodies they produce, that the SERA program is focused on. Not only can they tell us what infections we’ve been exposed to in the past, but they can tell us what infections we’re fighting off at the present. Of course, many people with ME/CFS are probably familiar with standard antibody tests. Serimmune, however, takes antibody tests to a whole new level.

SERA’s Superpowers


Serimmune and its SERA technology bring some new superpowers to the game of antibody testing. First, SERA uses E. coli bacteria that have been engineered to produce tens of billions of different peptides (short chains of amino acids). If a person has been exposed to a pathogen, some of those peptides will stick to antibodies they’ve produced to combat it.

SERA’s gift to the medical world is its ability to survey in exquisite detail the sticking points of the antibodies that are produced in reaction to an infection. Determining which peptides stick to IgG antibodies in a person’s blood allows SERA to develop an “epitope map“;’ i.e. a map of the sites that the antibodies in a person’s blood have bound to. The ability to produce that map allows SERA to produce a much more precise assessment of a past infection. In fact, SERA’s findings have been used to determine whether the current vaccines will be able to stop the coronavirus variants. One researcher called that impressive result “the tip of the iceberg for what Serimmune can do”.

Serimmune’s next ace up its biological sleeve is the unusually large amounts of data it has available to inform its findings. Serimmune already has terabytes of data available, but it’s hungry for more as the machine learning technique it uses gets better the more data it has.

Serimmune’s ability to determine if you’ve been exposed to some potentially key – and difficult to diagnose – infections is a pretty neat trick for a post-viral disease. It’s remarkable how many people remember the day the axe, so to speak, fell. Plus, we’ve learned from long COVID it’s even possible to have an infection that produces a long-term disease like ME/CFS without ever being aware that you were infected.

Bacteria, viruses and more, Serimmune’s technology can pick up the immune response to all of them. This study focuses on tick-borne infections and the coronavirus.

By the time SERA’s work has been done, one should be able to determine what pathogens a person has been exposed to throughout their lifespan. For the purposes of this study, though, Serimmune has developed two assays – one for tick-borne illnesses and one for the SARS-CoV-2 pathogen that produces COVID-19 and long COVID.

Serimmune’s assay for Lyme and tick-borne diseases is reportedly “best-in-class”. The current Lyme assays have notoriously poor sensitivity (they can miss cases of Lyme) and specificity (they can also falsely suggest someone has Lyme) – particularly when done in the earlier stages of infection. In fact, it’s been estimated that up to half of all Lyme cases may be missed by the current assays.

Serimmune’s assay – which assesses hundreds of potential epitopes – on the other hand, was found to have a specificity of 98.6%, and its sensitivity dramatically improved that seen in the standard assay (from 62% to 77%).

(Serimmune is also developing an assay for a disease (Sjogren’s Syndrome (SS)) of interest in ME/CFS, postural orthostatic tachycardia syndrome (POTS), and related diseases because of the possibility that it’s being radically underdiagnosed, ironically, because of faulty antibody tests.)

Serimmune’s Research Study

The Gist

  • Serrimmune is a cutting-edge Santa Barbara “immune intelligence” company that’s using mounds of antibody data to more accurately diagnose who has been infected with what.
  • Antibodies latch onto a pathogen – blocking it from entering a cell and alerting the immune system to its presence. Memory antibodies are also formed that quickly alert the immune system to the pathogen’s presence if it comes around again.
  • Serimmune and its SERA tool assess many more aspects of antibody prevalence than other tests – allowing the company to create an “epitope map” – and potentially making its antibody findings much more precise. Serimmune, for instance, has reportedly produced “best-in-class” antibody tests for Lyme disease.
  • Serimmune has launched a 5-year free antibody study aimed, in part, at people with fatiguing diseases like ME/CFS and fibromyalgia. People who sign up for the study can have their antibodies to the coronavirus and/or tick-borne pathogens that produce Lyme, Ehrlichiosis, anaplasmosis, babesiosis, and Chagas disease.
  • The coronavirus part of the study will assess if you’ve been exposed to the virus even if you’ve been vaccinated. (If you’ve been exposed but were never vaccinated it will show that as well). The tick-borne part of the study will assess if you’ve been exposed recently or in the past to a tick-borne pathogen. (How far the test can reach back into the past depends on how long the antibodies stick around – see the blog for more details).
  • Please note that the coronavirus test comes standard with the study. If you wish to have your antibodies to tick-borne illnesses assessed you must check the box for that. 
  • The study is open to people who are over 18 years old and live in U.S.
  • Please note that these tests are not FDA-approved and that any positive results should be followed up with FDA-approved tests at your physician’s office.
  • Upon entry to the study, you will receive a Tasso blood collection device you can use at home. The device does not use needles to draw your blood.
  • Every couple of months for the next five years you will receive another collection device and Serimmune will inform you of the results. (Other pathogens may be included in the future). Serimmune will use this data to better perfect its analyses and hopes to produce antibody signatures specific to ME/CFS.
  • See the end of the blog to learn how to enter this study.

Serimmune is looking for people with fatiguing illnesses, including chronic fatigue syndrome (ME/CFS) as well as fibromyalgia and others. It should be noted that – as with all these big data studies – more is better. The more ME/CFS/FM patients that participate in the study, the better opportunity Serimmune will have to uncover ME/CFS/FM subsets or even possibly unique ME/CFS/FM antibody signatures. (Note that the  study is not presently assessing the presence of ME/CFS, It will have to do that at some point if it is to uncover ME/CFS subsets – which it has said it is interested in doing.)

Tick-borne Illnesses – If you chose to participate in Serimmune’s research study, it will provide information that could help you learn if you’ve been recently exposed, or in some cases, have ever been exposed to a tick-borne illness such as Lyme, Ehrlichiosis, anaplasmosis, babesiosis and Chagas disease. As these tests are often hard to come by, and not always accurate, this is a real opportunity to learn if you might have been infected by one of these pathogens.

The results will fall into three ranges:

  1. Recent exposure – If this result comes back negative, it suggests you have not been recently exposed to the pathogen. If the result comes back positive; i.e. it suggests that you have been recently exposed, but it does not mean that you necessarily have an active infection. A positive result ranges from 30 to 200. A higher score – which generally means that a higher number of distinct antibody species and/or higher antibody titers have been found – is more indicative of an active infection, but Serimmune is not willing to state that an active infection is present. (Note that this study is for research purposes only and that any positive results should be followed up with an FDA-approved test and a doctor visit.)
  2. Indeterminate result – The test cannot determine whether or not you’ve been exposed to the pathogen.
  3. Exposed – You may have been exposed to the pathogen in the past. How far back in the past SERA can pick evidence of an infection depends on how long the antibody response remains, and this varies from pathogen to pathogen. For instance, while the antibody response to the Pfizer/Moderna coronavirus vaccines fades after about four months, it lasts for about a year if you’ve actually been infected with the virus. The antibody response to the Borrelia bacteria responsible for Lyme disease, on the other hand, appears to last for 10-20 years, and it can remain high for life after an Epstein-Barr virus infection. (I could not find studies assessing the duration of the antibody response for the other pathogens.)

Coronavirus Infection and Vaccination Study – The study will also assess your immune response to determine if you’ve been exposed to the coronavirus vs having received the vaccine. Three possibilities exist:

  • If you’ve never been exposed to the virus, but have been vaccinated, the test will show that your immune system is producing antibodies to the spike protein but not other parts of the virus. (This does not mean the vaccine is less effective than being exposed to the virus).
  • If you’ve been vaccinated and have been exposed to the virus, the test will pick up the more comprehensive antibody response and tell you you’ve been exposed to the virus.
  • If you haven’t been vaccinated, but have been exposed to the virus, the test will show that as well.

Basically, the test offers to clear up a big question for many of us: have I been exposed to the virus?

Research and Investigational Purposes

The study notes that it is for “research and investigational purposes only” and that its tests have not been approved as diagnostic tests; i.e. any positive results should be confirmed by an FDA-approved test and a physician.

Free and Easy!

Tasso no-needle blood collection

Tasso’s no-needle blood collection gadget.

The study is free of charge – and is remarkably easy to participate in. No lab draws needed! No needles required!

You get a Tasso collection kit with a little gadget that you stick on your arm for 5 minutes which magically sucks out the small amounts of blood needed to do the test. Then you just mail the sample back to the company in the kit they provide, and you’re done.

Serimmune will also send you a new kit on a regular basis over the next five years or so in order to monitor your exposure to the SARS-CoV-2 coronavirus and tick-borne infections, and possibly other pathogens.

If you are over 18 years old and live in the U.S., you can participate in this study.

If you’d like to participate in the COVID19 study and get free COVID and tick-borne disease antibody results, you can enroll in it using this link. Note that this is not an ME/CFS/FM specific study and doesn’t mention either disease in the description or the questionnaire. (It asks about the presence of chronic fatigue in the study questionnaire).

It’s a large study that includes healthy controls and has a focus on fatiguing illnesses. Serimmune reached out to Health Rising because it would like to have as many people with ME/CFS and similar fatiguing illnesses participate in the study as possible.

Please also note that the study automatically assesses your coronavirus antibodies but if you want to get your tick antibodies assessed as well you must click the box at the top. 

Thanks to Kristin Loomis of the HHV-6 Foundation, who contacted Serimmune and proposed that ME/CFS patients be contacted about this study.

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