In March 2021, LymeDisease.org shared information about research into the gut microbiomes of people with chronic Lyme disease. At that time, Flightpath Biosciences was recruiting Lyme patients willing to donate blood and stool samples for the project. (Note: the study is now fully enrolled, and applications are no longer open.) Interest in the community was high and many of our readers enrolled as participants.

We’re excited to report on the project’s progress as this small company continues to blaze new trails for patients. As you’ll see, the trails are not without bumps and the road is sometimes unpredictable. We asked Matt Tindall, Flightpath’s CEO, to provide an update on the status of this important undertaking.

By Matt Tindall

We are grateful for the enthusiastic response and participation in our ongoing clinical biomarker study of chronic Lyme disease.

As a person with friends and family who have suffered from Lyme disease and as a founder and leader of a start-up biotechnology company working to serve this large patient community, I want to personally thank each of our participants. Their willingness to dive into this research with us, giving their time and energy, has been incredible. I’d also like to provide the community with an update on the project.

First, we’re happy to report that more than 900 participants have enrolled in this study. When Flightpath joined the Illumina Accelerator and embarked on this effort to deeply analyze biological samples from chronic Lyme patients, we thought it might take us six months or more to complete enrollment.

Our team put together a bold and comprehensive study protocol that required many partners, vendors and service providers and in March 2021 we achieved our first-ever Institutional Review Board (IRB) approval to enroll up to 500 participants in this first-of-its-kind clinical study. (Under federal regulations, IRB approval is required for biomedical research involving human subjects.) This was our “Moon Shot” for patients with Lyme disease.

A whirlwind of interest

Then we launched. The whirlwind of interest in this study was overwhelming. We reached our enrollment goals in the first 12 hours! Because of the strong level of support from the Lyme disease community, we quickly explored whether we could expand the study to include even more people.

An expansion required amendments to the IRB approval —and some re-tooling of our behind-the-scenes efforts. We also needed to raise incremental funding to support the additional data collection and analysis. Fortunately, with a strong and supportive team, we were able to reorganize successfully within a very short time period.

Within a few weeks we were back on track with a new, expanded IRB approval and we re-opened the study to enroll more patients. We reached our second enrollment goal of >900 patients within 48 hours. It was a truly remarkable milestone and a clear signal from the community.

If you are a part of this study, you are now a participant in the largest study ever conducted by a private company in chronic Lyme disease. While we are small, our aim from the beginning has been to ignore distractions and to Think Big to generate hard data to understand the causes and biological impacts of chronic Lyme disease.

Who is participating in the study?

Of the 900+ patients enrolled in the study, 250 are healthy donors who have not been previously diagnosed with Lyme disease and do not live in traditionally Lyme endemic regions. This healthy donor pool gives scientists what’s called a “biological baseline” to compare chronic Lyme participant data against.

Our primary aim is to detect the differences in the two populations and confirm a “chronic Lyme disease signature.” The additional 600+ participants with chronic Lyme disease are at least 18 years old, US citizens and have received either a visual clinical diagnosis by a physician (rash) or a CDC-positive Western blot or ELISA confirmatory lab test.

Unforeseen challenges and solutions

We did not predict the magnitude of the interest in our study. With the surge in enrollments, many participants have experienced long delays in receiving kits, slow follow-up on study questions and long wait times for electronic gift cards.

We also struggled initially to triage the large volume of emails and phone calls regarding the study. That’s on us. We’re solving each issue one by one and we’re making strong progress. Because we know this community appreciates transparency, let me share a few of the challenges we have faced in more detail.

Flightpath and its vendors and service partners were prepared to deliver a certain number of  “kits per week” at launch but not more than 500 kits in two weeks. The impact of the accelerated delivery timelines became obvious quickly and was exaggerated when we expanded the study.

In addition to a basic supply-demand imbalance, we found new and additional downstream impacts from Covid-19. There were unforeseen materials shortages in key elements of our study kits. When we went to re-order materials, our vendors simply didn’t have key products available to satisfy our needs. Any one product delay would cause all kits to be delayed. This became a huge obstacle.

But, we marched on. By the first week of June, we had finally shipped hundreds of new study kits and we were excited to see blood draw appointments being scheduled and hundreds of completed kits hitting the lab. We had solved the problem of how to meet the higher initial logistics demands created by the large study enrollment. But no sooner than we solved this problem, a second obstacle arose.

Problems with blood collection tubes

On the morning of June 9, I began to receive urgent texts and calls from our mobile blood collection service professionals all over the country. Our phlebotomy coordinator said she had several phlebotomists reporting failed collections. It appeared that our Zymo Research R1150 blood collection tubes were not compatible with the plastic blood draw docks that phlebotomists use to collect blood.

We were stunned and baffled. Anyone in our business knows these are standard tubes with specific sizes and a long history of use in the field. At this point, the team had conducted almost 200 blood draws and completed kits without issues. And yet, suddenly, something was not right.

It was time to quickly put on our Sherlock Holmes hats and dig in. It turned out that our blood tube supplier had changed the size of the tops of their tubes by one millimeter without noting it or mentioning it to their distributors or customers. Same tubes + different size = HUGE PROBLEM.

We had hundreds of kits with these new, irregular tubes sitting in participants’ homes and they were nearly all scheduled to be used for blood draw appointments. But the new tubes wouldn’t work for traditional blood collections.  We had to halt everything.

Now that we knew the problem, we (and our gracious partners) went into overdrive to fix it as quickly as possible. The solution – replacement tubes. We put a plan in place to send replacement tubes to hundreds of addresses overnight (new boxes, bubble wrap and functional tubes). But, there were 38 appointments scheduled that day and more in the days to follow.

Because optimism was our only choice – we and our partners put heads down and worked on solving the problem. Some of the readers of this blog may find these “replacement tubes” on their doorstep this morning or early next week.  If you are a participant in the study – thank you for your understanding regarding this matter. Please just add them to your kit supplies and wait to be contacted by your mobile phlebotomist.

In the meantime, you can always collect your gut microbiome sample. The completed stool sample tube can remain with your other supplies at room temperature until your blood collection. Thank you for your patience, our apologies for any inconvenience.

Another glitch

Later in the day on June 9, in the throes of the first issue, we noticed a post on social media that we didn’t expect. It described a logistical issue but an important one. The message went something like this (paraphrased): “…Has anyone else completed their kit and not received their gift card?…”

Now, June 9 was really “not our day.” The eGift cards that Flightpath offers as a thank you for participating in our study are directly tied to “completed kits” (4 samples in a box) as entered by our lab partner.

As it turned out, there were some glitches in the system which have now been ironed out. If you are a participant in the study and have received a kit by mail, please make sure that you complete all of the following steps which are required before you are eligible for the eGift card:

• Schedule your blood draw appointment (ExamOne will contact you to find a date and time that works for you both)
• Complete your gut microbiome collection tube (prior to your blood collection visit)*
• Complete your at-home blood collection appointment (2 tubes, 1 dried blood spot card)
• Confirm that your ExamOne collector seals the kit and is headed to FedEx!

*Data from this sample will only be accurate if the participant has not taken antibiotics for 14 days prior to sample collection. Study subjects should consult with their physician prior to stopping any prescribed medical treatment. For your convenience, if a study participant requires more time to collect this sample, we have provided a second, back-up shipping label in the gut microbiome box that can be used to send this component separately.

NOTE: If you could not complete all components of your kit, please let us know and we will try to help you with the missing piece(s).  Our Flightpath Lyme Study contact information is listed here: voicemail (510) 859-8668 and email inquiries can be sent to: FlightpathLymeStudy@gmail.com. Please allow us up to 48 hours to respond to each inquiry.

We’ve also heard feedback from a few people that the person who collects the blood “doesn’t know anything about the study.” This is to be expected. We make use of mobile phlebotomists  (health workers who draw blood) throughout the United States who provide this service for many companies and many studies.

Hence, they are not part of our internal team and are not able to answer questions about the study. They are front-line workers scheduling visits by phone and visiting study subjects at homes all over their local territories. They deserve our kindness. It’s a difficult job. However, if you’ve struggled with these interactions, we sincerely apologize. We are committed to getting it right for you and improving our processes on our journey to understanding Lyme disease.

The path forward

As we come up for air from an aggressive launch, we’re starting to hit our stride and it doesn’t end with sample collection. We will begin to work with our scientific research team to look at the raw data from hundreds of patient samples. This will hopefully tell us more about the importance of specific gut bacteria, the significance of molecules in blood and the relationships between healthy and Lyme-positive immune systems.

This time-intensive work should take about a year. At the conclusion of the study, we hope to publish our findings and to use the data to develop new diagnostic tests for chronic Lyme disease, to evaluate new therapeutic treatment options and to guide medical therapy selection in the future.

Now the hard part begins for Flightpath and our partners. According to our lab partner, we had 200 fully completed kits as of early June. That means we have roughly 400 more kits to collect from the patients with chronic Lyme disease.  In short, we need study participants to stay the course and continue to complete their kits. Once all the samples are collected and complete, we will focus on turning raw biological data into aggregated but specific scientific insights.

We’re incredibly excited by this opportunity to work with this community and we’re working daily (and nightly) to make it happen. With your continued support, patience and encouragement – we will change the course of Lyme disease

Matt Tindall is Co-founder, President and CEO of Flightpath Biosciences, Inc.