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BackTable / Urology / Article
At-Home Semen Analysis: Lowering Cost & Expanding Access Through Innovation
Sophie Frankenthal • Updated Dec 2, 2024 • 34 hits
Semen analysis is a routinely-employed diagnostic tool in a variety of cases such as male infertility or post-vasectomy follow-up. It involves the assessment of male ejaculate for parameters such as sperm count, motility, and morphology as a means of determining sperm quality and overall fertility. Traditionally, the test requires that the sample be collected and transported to a laboratory within an hour to maintain accuracy, as sperm motility declines over time. Unfortunately, challenges such as limited lab access, logistical constraints, and high costs make testing difficult for many patients.
Urologist Dr. James Smith highlights these challenges and introduces the Fellow kit, an innovative at-home semen analysis. This non-invasive solution is designed to enhance accessibility and compliance without compromising the accuracy needed for effective fertility care.
This article features excerpts from the BackTable Urology Podcast. We’ve provided the highlight reel in this article, but you can listen to the full podcast below.
The BackTable Urology Brief
• Access to semen analysis is limited by geographic, logistical, and financial constraints. Common challenges include a lack of nearby labs, time-sensitive sample processing requirements, and high costs, all of which contribute to low utilization amongst patients with suspected fertility challenges and low compliance rates amongst post-vasectomy patients.
• Fellow’s innovative at-home semen analysis kit addresses barriers to access by correcting for known declines in sperm motility, thereby extending sample viability to 52 hours. This allows for patients to bypass travel and logistical hurdles without compromising on accuracy.
• While Fellow is a cost-effective and accessible screening tool, it is not suitable for complex diagnostic needs such as in cases of retrograde ejaculation or infection, which still require traditional lab tests.
• Fellow’s success in increasing access to semen analysis is paving the way for future innovations, including the development of molecular and epigenetic markers to enhance fertility predictions and personalize treatment.
Table of Contents
(1) Barriers to Semen Analysis Access
(2) Fellow: An Innovative Approach to Semen Analysis
(3) The Fellow Workflow: From Sample to Analysis
(4) New Standards in Semen Analysis
Barriers to Semen Analysis Access
Many patients face significant barriers to accessing semen analysis, including geographical limitations, logistical hurdles, and financial constraints. A primary challenge is the limited availability of labs offering this service, particularly in rural or remote areas. This difficulty is further compounded by the time-sensitive nature of semen analysis, which requires samples to be processed within an hour of collection. For patients without access to a nearby lab, this constraint creates a significant logistical challenge, especially for those balancing work and other commitments. Financial concerns add another layer of complexity, with semen analysis costs ranging from $150 to $500 and insurance coverage often limited.
These accessibility challenges likely contribute to low compliance with post-vasectomy semen analysis. Although the AUA guidelines recommend testing at 12 weeks post-procedure, adherence remains at 25-50%. Addressing the obstacles of access, cost, and logistics is essential for improving compliance and ensuring equitable availability of this important diagnostic tool.
[Dr. Jose Silva]
You mentioned already the semen analysis and what were some of the barriers of people doing a semen analysis and I'll talk as a general urologist and I see a difference between a patient going to just the lab in the corner versus I try going to a fertility clinic. I guess now with Fellow, it's different, but in the past, that patient that just wants to do a general checkup, do you always tell them to go to a specific lab or what do you do in the past?
[Dr. James Smith]
It gets to be the convenience as well as things like, "Does your insurance cover?" For Northern California, patients who are coming from hours away to relatively close by in San Francisco and so it really depends. Some of my patients are in the East Bay of San Francisco or in the South Bay of the Bay Area and so we'll look for places that they can get their semen analysis done.
That's one of the significant barriers, is actually trying to find a lab that offers a semen analysis, finding a lab that does a post-vasectomy semen analysis. That's pretty tricky. There are quite a few labs that have stopped offering the semen analysis. In many of the far-flung areas, they may not have a lab to do the semen analysis. Those are challenges and those were really some of the main pain points that got me really interested in the concept behind Fellow in the beginning.
[Dr. Jose Silva]
You mentioned the accessibility, and traditionally it's 45 minutes that you need to process the sample, right? Or–
[Dr. James Smith]
An hour.
[Dr. Jose Silva]
-was it a little bit or an hour?
[Dr. James Smith]
One hour.
[Dr. Jose Silva]
You mentioned access before. Is there literature around this, around semen analysis and access to that semen analysis?
[Dr. James Smith]
It depends on what you talk about. There's literature around things like compliance with testing, for example, as terms of one metric of access. The AUA guidelines recommend that all men get a semen analysis after they get their vasectomy done, usually around 12 weeks or so after the vasectomy. The studies typically are around 25% to 50% compliance with that. That's impartial due to the kind of barriers and access one way or the other.
Like many conditions, we suspect that race, education, income are all potential barriers. The occupation that a person has, the ability to take time off of work and drop everything that they're doing and go to a place, produce a sample in a lab in the middle of the day. There are lots of logistics barriers, there can be cost barriers, the cost for semen analysis ranges quite widely and can range from $150 up to $500 for a semen analysis and insurance often doesn't cover very well.
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Fellow: An Innovative Approach to Semen Analysis
Advancements in semen analysis technology, such as those pioneered by Fellow, address key barriers to traditional lab-based semen analysis by enabling accurate results from samples collected remotely. Traditional semen analysis is constrained by a one-hour processing window to avoid inaccuracies caused by sperm motility loss that occurs due to cell death. Fellow’s kit mitigates this limitation by accounting for known declines in motility, even up to 52 hours after sample production, through factors like temperature control and optimized sperm media. This innovation allows patients to produce samples at home and ship them overnight for analysis, eliminating the need to travel to a specialized lab.
Given that Fellow is primarily a screening tool, it may not suit candidates requiring advanced diagnostic tests such as post-ejaculate urine analysis for retrograde ejaculation or leukocyte staining for infection. For these needs, traditional lab testing remains necessary. Despite these limitations, Fellow has made semen analysis more accessible and cost-effective for a broader patient population.
[Dr. Jose Silva]
When the founder of Fellow approached you and he told you that, "Hey, there might be a solution." How do you approach this? You will fall in with a suggestion or what happened at that point?
[Dr. James Smith]
…We had to test a range of conditions. We had to figure out why it was that the WHO requires a one-hour time to get the sample in. In large part, it's due to the inaccuracy of cell death, of the loss of motility. Motility in a semen analysis is a marker for the cells just died. If the sample is produced and then analyzed after an hour, you really can't give an accurate result because the cells have died at inconsistent rates.
What we had to do in the lab in the beginning was really to figure out what drives that. We found that temperature was important, the kind of sperm media that you use was important, bacterial overgrowth was important. These were all factors that we were testing extensively and with thousands of semen analyses and many different permutations of these parameters. Eventually, we were able to design a kit and that's led to the clinical validation paper that we published in Fertility and Sterility a couple of years ago, where we were able to show that with the kit, you can see a linear decline in motility.
Now, when a sample shows up in the Fellow lab, we're able to correct for a known decline in motility over time. If a sample shows up anywhere up to 52 hours after production, we can give a highly accurate semen analysis reading. That's really is a game changer because then my patients who live three hours away can produce a semen sample and those are shipped overnight back to the Fellow lab. It comes, say, 35 hours later. That patient doesn't have to take a long trip, a three-hour trip here and a three-hour trip back. He's able to get a CLIA-accredited semen analysis from the comfort of their own home.
[Dr. Jose Silva]
You mentioned in the past, in terms of insurance, patients maybe they don't want to pay out of pocket. What do you tell the patient? Maybe at the end of the day, they're actually saving money by just going straight to this more specific or easier test to be done in their house. How do you word the patient or how do you talk to the patient about this?
[Dr. James Smith]
Yes, patients often ask me that question. Often when they're thinking about their diagnostic testing, they're wanting to use their insurances as best they can. I tell them that they can submit the receipt for their semen analysis, whether it's Fellow or the in-person semen analysis, and submit that. It's usually is reimbursed by their FSA or HSA accounts, Carrot, and Progeny. Some of the insurance benefit managers, they will often reimburse the semen analysis.
I think you're right. I think that that's the calculation that the patients are thinking through. The Fellow semen analysis costs $189 for the semen analysis, $139 for the vasectomy semen analysis. They're thinking, "How much is the hassle factor, taking time off work, going in?" It's grown increasingly popular all around the country.
[Dr. Jose Silva]
Is there a patient that is not a candidate to using this type of technology? You will say, "Hey, just go to the fertility clinic," for example.
[Dr. James Smith]
Yes. I think the Fellow semen analysis is a terrific screening test. I think it's great for figuring out if a man has normal parameters, abnormal parameters, azoospermia. For patients who have very low ejaculate volume, the Fellow does not do a post-ejaculate urine analysis test. We don't currently do leukocyte staining. If someone was concerned about infection that way, there's not a culture of the semen or looking for leukocytes. Those are a couple of situations that would not be a good fit for Fellow. For example, if the semen volume was low and I got it from Fellow, I would often send a second semen analysis at UCSF and I would get a post-ejaculate urine analysis to look for a retrograde ejaculation in that patient.
[Dr. Jose Silva]
Also not many labs are doing the post-micturition test. It's not like it's going to be easy to find one.
[Dr. James Smith]
No, that's exactly right. For this kind of specialty situations, often men are coming to a reproductive urologist to exactly– to sort that out. For reproductive urologists, we have partnerships with high-quality labs that can do that advanced testing. Going down the road of Fellow, that's some of the things that I get excited about is to be able to add that on to the offering at Fellow, so that eventually, there would be a whole host of andrology tests that could come out of the semen analysis.
The Fellow Workflow: From Sample to Analysis
Fellow’s semen analysis kit incorporates critical innovations to maintain sample viability during transport, ensuring accurate results even up to 52 hours post-production. A gel buffer stabilizes the sample at room temperature, preventing motility loss caused by extreme heat or cold. The kit’s proprietary preservative, enriched with essential nutrients, sustains sperm cells, while an antibiotic minimizes bacterial overgrowth and reduces cell clumping, preserving sample integrity.
Samples are shipped overnight to ensure timely arrival at the lab. Any sample exceeding the 52-hour threshold is promptly rejected and replaced at no cost to the patient. Upon arrival, each sample undergoes a thorough evaluation, beginning with a manual check for abnormalities or insufficient sperm count. Those meeting initial standards are analyzed using Computer Assisted Semen Analysis (CASA), while samples showing abnormalities receive further manual analysis.
Fellow’s commitment to precision is reinforced by stringent lab protocols, including daily quality control checks, regular machine collaboration, and continuous staff training. Patients are typically advised to abstain from ejaculation for 2-5 days prior to sample collection, optimizing the quality of the analysis. Collectively, these measures uphold the reliability and accuracy of the semen analysis process, while simultaneously improving accessibility.
[Dr. Jose Silva]
Curious about that specificity of the antibiotic. You started seeing some clumping in the specimen. Now let's throw in an antibiotic.
[Dr. James Smith]
What we'll see in the lab, so we'll open up a kit and we'll assess, the first thing that we do when the kit arrives in the lab is we assess how long it's been since the man produced the sample. If it's longer than 52 hours, that sample gets rejected and the man just gets a free kit. There are those kinds of delays. Sometimes if there's a blizzard in the middle of the country and the sample's coming from Florida to California. It doesn't happen too much. UPS does a really good job. That's one of the checks.
Another check is to do a quick look. Every sample that comes in, a slide is made and there's a quick manual check. Is this normal? If it looks roughly there's a lot of cells there, then we have an automated approach, a CASA approach to the analysis. If on the quick look, there's not very many cells, then it's a manual semen analysis that we do. That's also the stage where we could tell if there's a lot of bacteria. You could just see all the cells have clumped up. At that point, the damage is done. We would reject that sample, send another kit, just free another kit, and we'd go back out and make sure to wash your hands and produce the sample as sterile or clean as a way as possible
.
[Dr. Jose Silva]
Just to summarize what we were saying in terms of the high-quality lab that you guys are running this test, there's the temperature control that you do it by the gel, there's the nutrients, antibiotics, and also the data that you collected to know the degrade of the cells.
[Dr. James Smith]
Yes, that's right. It's very different at a lab where we average now more than 300 semen analyses in a day. There's no lab in the country, let alone the world, that one lab is doing hundreds and hundreds of semen analyses. As far as our CLIA lab is concerned, we're making sure that everybody has their training up to date, the machines are calibrated regularly, that QC is happening every single day. This is something that really sets us apart from most labs. We are really the busiest lab. Our team is very, very good at doing semen analyses.
[Dr. Jose Silva]
The 52-hour mark was just based on your data?
[Dr. James Smith]
Correct. We looked at it longer than that. We found that linearity, as time went by, we actually looked out to about four days, and it remained linear a little bit longer than that 52 hours. As time went by, either the nutrients disappeared, and it would die, or we could also find the bacterial blooms also occurred over time, but in that 52 hours, it was highly linear decline. We had highly accurate predictability.
[Dr. Jose Silva]
In terms of the patient per se, how long do you tell the patient to be abstinent?
[Dr. James Smith]
Two days usually. Two to five days, kind of the sweet spot.
New Standards in Semen Analysis
Originating as a small startup, Fellow has scaled into a CLIA-certified laboratory capable of processing high volumes of semen analyses while maintaining rigorous quality standards. Beyond traditional assessments, the integration of molecular and epigenetic markers hold promise for predicting fertility outcomes and personalizing treatments. Additionally, research suggests that innovative at-home testing kits, such as those offered by Fellow, significantly reduce disparities in access to care across socioeconomic and racial demographics. By combining patient data collection with collaborative research, these advancements aim to refine clinical decision-making and expand the predictive capacity of male fertility evaluations.
[Dr. Jose Silva]
Jim, in terms of down the road, you mentioned the different types of molecules that you used to test when you were a student. How do you see the future?
[Dr. James Smith]
I think this for me is one of the most exciting things that we can do. I'll back up a little bit. Fellow really began in this teeny little lab space. It was a startup of startups outside of UCSF. It was in this little incubator space. As we did these thousands of semen analyses, we're building the kit. Eventually we took that technology that we developed through this R&D process and transferred it to a CLIA lab. The first CLIA inspector told us that we had at a 50 square foot little bench that we had the smallest CLIA lab that he'd ever certified.
[Dr. Jose Silva]
Back when you met the founder, there was no CLIA, there was no company yet?
[Dr. James Smith]
There was nothing. No. When I met the founder, I met him outside of UCSF in a cafe. There was just an idea. He's a really bright guy, had been investigating the space, and wanted to do something in male reproductive health. It really came directly from doctors and patients and what are some of the needs that we have as urologists caring for our patients.
[Dr. Jose Silva]
Awesome, and then you went to work?
[Dr. James Smith]
Also that as a team. There were some terrific engineers and terrific folks who really did a lot of the hard work to get this done. It was a pretty expensive process to develop the Fellow kit. I remember back in the beginning, there were exciting ones that did turn into a company, was CLIA-accredited, where Will would tell me and he'd say, "Jim, there were 10 semen analyses this week." That just kept ramping up. Two weeks ago, there were about 450 semen analyses in one day. It's been a really exciting ride.
Where that leads to your question is that what we're able to do really well now is to get a semen sample from any place in the country to one really high quality lab in the Bay Area, in San Leandro, near the Oakland airport. There is a lot of information in a semen sample that we just don't currently have the capability to test at scale. There are certainly molecular markers. Some colleagues have looked for epigenetic markers in semen that perhaps could predict fertility outcomes. Perhaps there are environmental markers, whether it's environmental toxicants or other markers in semen that we could learn about. That's one of the things that I'm excited to do, down the road as the company continues to grow, is to try and develop brand new tests that can actually move the needle for our patients.
[Dr. Jose Silva]
Just like genomics for high-risk versus low-risk, just go straight to this. That would be awesome.
[Dr. James Smith]
That's right. The semen analysis is really helpful to put men into these groups, is this, "Things look generally pretty great. You're low, but okay, you may be able to conceive, get enough time to really low," like IVF may be the right thing, but can we do better than that? Can we do develop better biomarkers that are helping to predict who's going to succeed with your varicocele surgery? We still don't know that terribly well. Going down the road, could we predict something about BPH or other aspects of a man's reproductive health?
I'll circle back around to one of the things that I'm also excited about. When I think about breaking down barriers and access to care, one of my colleagues was very curious about whether or not Fellow would break down barriers and access from an education, income, and race standpoint. This is a colleague of mine named Alicia Tolani. Dr. Tolani is an REI Fellow at UCSF. We have a fertility clinic at our San Francisco General Hospital or County Hospital. She was finding that it was really often very difficult for these patients to get a semen analysis. They couldn't proceed with their REI care until they had a basic semen analysis.
She and I began collaborating and wanted to look to see whether or not there'd be differences in men turning in their kits based on race, education, income. We hypothesized that there would be really big differences. Alicia presented these data at Pacific Coast Reproductive Society just the other day down in Palm Springs and found that Fellow appears to really break down those barriers. That the rates of getting the kit back were 90% or better. It didn't matter whether a person was Black, white, rich, or poor. That really was an exciting finding for us. That's the kind of thing that's really exciting and motivating for me in this new role to be able to try to help our patients that way.
…
[Dr. James Smith]
That's something that we'll track as far as the semen analysis goes. We'll ask them how long had they abstained.
[Dr. Jose Silva]
Does it change your variable? Does it change if it's two days or three days in terms of the report or something?
[Dr. James Smith]
Jose, I think that there's some really interesting insights that are going to come out of our Fellow lab to be able to try to answer that kind of a question. What we've built into the whole Fellow experience is every man is asked if he'd be interested in participating in research. He fills out a long questionnaire if he's willing, and we utilize that data to try to answer many of those questions. We've now have submitted or have accepted many abstracts diving into details of male reproductive health. It's something, again, that I'm really excited about. I'm excited to collaborate with partners around the country to be able to answer questions like that.
Additional resources:
Fellow:
https://meetfellow.com/
Podcast Contributors
Dr. James Smith
Dr. Jim Smith is a reproductive urologist and clinical professor at UCSF in San Fransisco and the chief medical officer at Fellow Health.
Dr. Jose Silva
Dr. Jose Silva is a board certified urologist practicing in Central Florida.
Cite This Podcast
BackTable, LLC (Producer). (2024, May 14). Ep. 167 – Solving Semen Analysis Barriers: Innovation & Accessibility [Audio podcast]. Retrieved from https://www.backtable.com
Disclaimer: The Materials available on BackTable.com are for informational and educational purposes only and are not a substitute for the professional judgment of a healthcare professional in diagnosing and treating patients. The opinions expressed by participants of the BackTable Podcast belong solely to the participants, and do not necessarily reflect the views of BackTable.
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