For this episode of the Microsamplify Podcast, we spoke with Clifford Morris, PhD, Director of Research and Development at Physicians Lab. Physicians Lab is a state-of-the-art laboratory in Florida that has developed a robust range of panels for analyzing blood and urine samples. They offer physicians and their patients several different wellness kits that allow for easy and affordable at-home specimen collection and remote patient monitoring. Dr. Morris and the Physicians Lab team recently added Mitra® microsampling from Neoteryx to allow them to offer blood tests for patients on hormone therapy. Patients can mail their blood samples directly to Physicians Lab for highly accurate analysis. The lab results will be submitted to their practitioners, who use the data to remotely monitor patients on hormone therapy, allowing them to stay safe at home.
Neoteryx: Hello Dr. Morris, and welcome to the Microsamplify Podcast from Neoteryx. Thanks for taking the time to speak with us about your work at Physicians Lab.
Dr. Morris: Thank you for having me, it’s a pleasure to be here to talk more about the exciting advancements we have been making.
Neoteryx: Can you tell us a little bit about yourself and your role at Physicians Lab?
Dr. Morris: Certainly. I am an analytical biochemist by training and have spent many years focusing on clinical sciences--from my graduate studies elucidating the biomechanism of Alzheimer’s disease to method development in toxicology, and now focusing on functional and integrative medicine at Physicians Lab. Currently, as the Director of Research and Development, my specific role is to identify new and novel testing methods to better support practitioners in their therapeutic decision making, and then develop them into a commercialized product. My role is also to ensure that our science is translated into effective medical testing solutions and that we constantly stay on the forefront of advancements in the field.
Neoteryx: Can you give us an overview of the services that Physicians Lab provides to both doctors and patients, and also which regions you serve?
Dr. Morris: Yes, Physician’s Lab is a CLIA and COLA accredited laboratory. We offer testing services for urinary hormones, urinary nutritional metabolomics, nutrigenomics, and now we have added dried blood spot testing with Mitra devices from Neoteryx. Our focus is on providing practitioners with effective and informative value-based testing that is highly correlated with outcome-based strategies. We provide practitioners with tools to do their job as best as they can, but our services go above and beyond clinical testing. We offer massive amounts of education and support to our practitioners.
Our testing is quite advanced in many ways, and we make sure that our practitioners are highly trained in understanding the science and medicine behind the testing, interpreting and understanding the reports, and most importantly, what action to take to develop a holistic and comprehensive therapeutic strategy for the patient. We key in heavily on individualization and personalization by offering algorithm-based dynamic text and recommendations, backed by volumes of peer-reviewed, outcome-based clinical studies as evidence. Everything we do focuses on empowering the practitioner and patient to find optimal health.
Roughly 80% of Americans die each year due to chronic health issues, and I am personally committed to reducing that number through developing affordable and universally accessible health and wellness solutions. The home health kits from Physicians Lab are made available exclusively to practitioners. The information is curated for a trained physician, so we want to make sure we respect that, and that’s the main reason we don’t yet offer our home health kits direct to consumer (DTC). In future, we may plan to offer some smaller panels DTC for patients who just want to check their basic biomarkers.
Neoteryx: Recently, you and the team at Physicians Lab developed a hormone testing panel that corresponds to two new hormone health kits for men and women. Can you explain which health conditions or treatments these new hormone kits and panels can be used for?
Dr. Morris: I am excited about the impact this hormone panel can have on our communities that are managing different types of hormone therapy. I think it’s important for everyone to realize that hormone therapy is not just for old people suffering from low or imbalanced hormones. Hormones control so many different aspects of our metabolism, immune system function and aging process. Monitoring your hormones, and hormone therapy, are rapidly becoming a popular tool for managing a range of health issues across all ages and cases. Our hormone panels offer an excellent way to check your hormone levels from the convenience of your home, and take control of your health.
Adding lab testing of Mitra blood samples to our offering furnishes practitioners with more information than they typically get from urine samples alone. The blood panel results can be paired with urinalysis results to provide additional clinical information about hormone metabolism, which helps doctors make more informed decisions regarding hormone balance, certain metabolic issues, and health risks.
These hormone panels also offer easy and affordable at-home sampling for the average patient who wants to take control of their overall health and wellness.
Neoteryx: How does blood microsampling with the Mitra® device from Neoteryx help you improve your services at Physicians Lab? For example, does Mitra and its volumetric absorptive microsampling, or VAMS® technology, provide a higher quality blood sample for more accurate lab results?
Dr. Morris: Over the past few years, Physicians Lab has attempted to deliver a consistent and accurate capillary blood spot collection method. Some of our competitors had already developed dried blood spot (DBS) testing based on newborn screening techniques, but we found several inherent issues with the DBS collection method that have traditionally contributed to inconsistencies and inaccuracies seen in every one of those laboratories.
The Mitra device made our new hormone panel possible through its innovative and reliable design and affordable cost. Just a few months before the COVID-19 outbreak, we partnered with Neoteryx to start using the Mitra blood collection device with volumetric absorptive microsampling.
The Mitra has been a game changer for us in our quest for patient-friendly blood spot collection that is also consistent and accurate. Although the plan for developing and launching this newfound technology in blood spot testing was initially set for September of this year, the sudden COVID-19 related stay-at-home orders increased the demand for telehealth and pushed this project to higher priority. Our team’s scientific knowledge, our lab’s state-of-the-art technology, and Neoteryx’s revolutionary blood collection device all came together perfectly to help us deliver this breakthrough technology to our practitioners.
For our needs, traditional DBS collection has a lot of issues. DBS is:
Difficult and messy to collect — Traditionally, dried blood spot testing was reserved for newborn screening and other clinical scenarios where trained professionals are tasked with collecting the blood spot. When we place this responsibility in the hands of the patients, the collection method needs to be easy and have as few “technique secrets” as possible.
Patient collection errors — When an untrained person is attempting to collect a blood sample (a task that is usually reserved for a trained professional) the collection method needs to be relatively fool-proof. DBS paper or cards, where the patient has to fit a drop of blood within a tiny circle on the paper card, can be quite challenging.
Frequent sample rejection at the lab — This is where the majority of complaints from our blood spot competitor laboratories reside. The patient has a hard enough time collecting one sample correctly. Then the clinician often finds that the patient had to recollect a second time with quite a bit of hand-holding to complete the second collection correctly. If the patient collects successfully on the first try, this doesn’t guarantee that the results will be accurate, however. Collecting the correct volume of blood onto a DBS card, within that tiny circle and with consistency, is very hard. With DBS cards, the laboratory may not receive an adequate amount of blood for testing.
Inaccuracy in volume estimations — These occur when using traditional FTA paper collections, due to the fact that blood is inconsistent in viscosity and absorbs into the paper at different rates. Additionally, patients who are trying to “meet the mark” on volume will often drop more than one spot of blood into the designated circles, creating more volume accuracy issues. These volume inaccuracies cause result inconsistencies.
Low level of correlation in “real patient” samples vs. venous whole blood due to volume variations — Laboratories will show you correlation data on DBS samples they collected with trained professionals who collected blood samples perfectly. However, when you compare patient-collected samples, the correlation can decrease dramatically. All this to say that when a patient is collecting at home, the collection method and collection device need to be fool-proof. The device needs to have a more specific way of determining how much blood volume was really collected in order to achieve accurate testing. For us, the Mitra does just that.
Neoteryx: For the lab researchers and lab directors in our audience, can you tell us in more detail about the equipment you’re using at Physicians Lab to conduct hormone testing, and if you had to adjust your lab setup to be compatible with Mitra microsampling and VAMS technology?
Dr. Morris: There was a high level of collaboration between our company and Neoteryx, which helped us to rapidly create a bespoke method that automates every part of the process.
We start by loading the Mitra tips onto a liquid handler that scans barcodes and places the tips into auto-racks for sampling. Then, the samples are extracted in various buffers depending on the assay they are being committed to, performed by a Biotage ExtraHera sample processor. This is one of the most interesting steps we have spent many, many hours learning. We worked very closely with the scientific team at Neoteryx to really get a deep understanding of the device’s proprietary absorptive polymer, the behavior of our analytes of interest, and modifying assays to support the device and whole blood matrix.
Once the analytes are extracted, we commit the samples to ELISA assays for the larger peptide hormones. Then we exclusively use high-resolution tandem mass spectrometry to quantify the small molecule hormones down to single digit picograms per mL. We use Sciex’s 6500+ instruments to make this possible, and are very grateful for the support they have shown to us during the process. The LCMS results are integrated automatically with flag-by-exception rule using Indigo Bioautomation’s Acent software, which is powered by data learning artificial intelligence. This takes the human subjectivity out of integration, improves throughput and, of course, increases consistency. This affords a high level of confidence in the results.
We are only just beginning to unlock the full potential of the Mitra device, and we are working rapidly to expand our offerings using Mitra.
Neoteryx: You mentioned that you’re hoping to use the Mitra device to further expand your services. Are you able to discuss future services that you’re developing using Mitra blood microsampling?
Dr. Morris: This initial panel was exclusively targeted at hormones and we are the first in the industry to offer hemoglobin and hematocrit via dried blood spot. Our current panel includes all major sex hormones and related peptide-hormones and binding proteins. We are already working on expanding our offerings. Our Next phase will include IGF, insulin, A1c and a thyroid panel. After that, we have some great ideas up our sleeves. We really want to dive deep into proteomics and developing a blood protein-based biological clock test. There is a ton of evidence to support proteomic biological clocks as a more accurate representation of biological age versus epigenetic-based biological clocks.
We also do a lot of work in urinary targeted metabolomics, and want to shift into the matrix of whole blood to expand on that. Lastly, we do offer some contract research work, and have an IRB on standby to be able to perform clinical studies on different therapies, nutraceuticals and supplements. It's honestly pretty difficult to focus on single projects with such a powerful and versatile device.
Neoteryx: For physicians wishing to use your services to offer health kits & remote lab testing to their patients, how should they get in touch with Physicians Lab, and what’s involved in getting set up with your services?
Dr. Morris: Your best bet is to visit our website, PhysiciansLab.com or our Linkedin page. From there you can easily get in contact with us and we can find a practitioner in your area. It’s all very easy and fully supports the telehealth model.
Neoteryx: You answered this next question somewhat in a previous answer, but…For patients wishing to take charge of managing their own health, are you offering any of your home health kits and lab testing services directly to consumers? Or, do they have to go through their physician or their health insurance company to access your services?
Dr. Morris: At this time we do not offer direct to consumer. We do accept some insurances, but it depends on your carrier and your practitioner. Right now, a cash model works well for everyone until the insurance companies can offer more coverage of home health kits and lab testing. At the risk of digressing too much from our conversation, I will say that we are trying to support the movement from a commodity volume-based laboratory model that is objectively broken and failing to develop laboratory testing that is value-based. We think labs should be focused on clinically actionable results leading to a decrease in the care-gap and faster, more effective therapeutic strategies. We support replacing the sick-care system with a truly proactive well-care system. I’m a big believer in this strategy. The pressure needs to be placed to drive adoption of a value- and outcomes-based system. That’s the only way it’s going to happen fast enough before irreversible damage or failure of the present system occurs.
Neoteryx: Is there anything you would like to add about what makes Physicians Lab unique from other labs, either in how you use microsampling or otherwise?
Dr. Morris: When we first set out to develop our new hormone health kits and our hormone testing method, we focused on offering a premium user experience in every part of the process - for both patient and practitioner. For the patient, we wanted to provide a simple and affordable way to collect a sample, and we also wanted to make them feel like they were touching state-of-the-art science with their own hands. Everything that Physicians Lab offers to patients is curated and premium-level quality, and so is the testing that complements it. We wanted patients to feel excited opening the kit. I really think we achieved this. For the practitioners, we wanted to offer a method that was simple to transfer over to from traditional serum labs, and make sure the results are accurate and reliable. That’s something that makes us very unique – our ability to identify what the market needs and deliver it in the form of an excellent product.
Something else that makes us unique is our dedication to education. Education is at the forefront of medical testing advancement – with the advent of new technologies, laboratories are plateauing on the analytical front. The biggest failure of laboratories is not in the testing itself, but rather everything else on the pre- and post-analytical sides. On the pre-analytical side, labs have not done enough to educate practitioners on what are the most up-to-date test offerings. Labs should educate practitioners on what each of these tests does, specifically, and when to order the tests. The goal is to reduce the number of mis-ordered tests—those that are not pertinent to clinically actionable outcomes. This will help reduce the queue burden in the labs.
On the post-analytical side, labs have not done enough to educate practitioners on how to interpret and fundamentally understand lab reports. Practitioners need the correct education to allow them to actualize the value of laboratory testing by turning direct measurements into functional assessments on a holistic level, with the patient outcome as the most important aspect. At Physicians Lab, we provide that education to practitioners. We want to empower practitioners to feel comfortable using the tools and data that we provide.
Neoteryx: Thank you, Dr. Morris, for speaking with us about Physicians Lab and your service capabilities. We wish you great success with microsampling and your many other offerings!
And, thanks to our audience for listening to this episode of the Microsamplify Podcast, a partner to The Microsampling Blog from Neoteryx.
All content provided by Physicians Lab, Inc. including without limitation all the information discussed herein is furnished for informational purposes only and does not constitute medical advice. This content cannot substitute for medical advice obtained from your medical practitioner. Listeners of the podcast understand and acknowledge responsibility to obtain medical care, treatment, and oversight from a medical practitioner. Never disregard professional medical advice or delay in seeking professional medical advice or treatment based on information found within this podcast or other information found via www.physicianslab.com.
Physicians Lab, an independent clinical laboratory and contract research organization (CRO)