Product Applications

Value:  Biomarker research and analysis require stable archived samples that can be accessed and reproducibly analyzed multiple times. The HemaSpot™ device contains 8 blades that allow reproducible analysis from blood samples that can be stored at room temperature for years.  Biomarker screening continues to be one of the highest growth areas in the field of diagnostics as well as in healthcare.  Indeed the promise of using a single drop of blood to identify early markers or indicators of diseases such as Alzheimer’s or cancer make the difficulties well worth the pursuit*.  Aside from sensitive techniques, which may include mass spectrometry and fluorescence probe detection, the challenge remains to identify predictive biomarkers that are meaningful and can consistently and accurately predict a potential disease state.  This can take years of painstaking work and an inordinate number of samples to investigate correlations. Blood samples, both current and archived, provide the key to this type of biomarker research.  Blood samples that can be stored safely for years without contamination or without losing sample integrity are critical to biomarker research and use.  In addition, the ability to easily pull multiple samples from an original blood draw is important since the testing and research can go on for years.  HemaSpot™ addresses these process issues in the following ways:

• The filter paper’s fan-shaped design allows the blood sample to evenly and reproducibly spread and dry on each of the 8 blades.  This means that one sample, when dried, produces 8 replicates that can be easily torn off and analyzed.
• HemaSpot™ combines ease-of-use with the sample stability of dried blood spot, which equates to years at room temperature. It also represents a blood sampling and storage system that can allow for multiple analyte testing events from the same blood sample over many years.

*What a drop can do: dried blood spots as a minimally invasive method for integrating biomarkers into population-based research.  Demography. 2007 Nov;44(4):899-925

Value: Use HemaSpot™ to reduce costs through space efficiencies, fewer freezers, and easier sample retrieval. Biorepositories (also known as biobanks) store large numbers of biological samples, such as blood, for use in clinical research and diagnostics. Traditional sample storage is in liquid nitrogen tanks or -20ºC and -80ºC freezers, which require significant infrastructure and personnel with the associated high costs. Accurate tracking and distribution of samples are difficult and samples can become destabilized when removed from storage for handling or shipping. Because of the HemaSpot™ device’s compact design and use of dried blood spot (DBS) technology, the space required for biobanking samples can be reduced by at least a factor of ten. This is primarily because liquid samples, which are 99% water, require relatively large storage containers. Because water facilitates degradation the liquid samples, thereby, need to be frozen. These large surface-space footprints are all eliminated with HemaSpot™ which only takes up only as much room as a matchbox. Also, with the integrated desiccant and moisture-tight seal, HemaSpot™ offers unprecedented control of humidity levels during collection and storage, thus ensuring consistent and stable samples. Sample collection and storage use the same, single container. Another important advantage, in addition to its compact size, is the ability to retrieve samples for analysis. The HemaSpot™ case has a bar code that can be used to easily identify the sample within a storage system. The device itself is also easy to retrieve samples from since it has 8 fan blades that can be plucked and analyzed individually giving you many consistent analyses from the same sample and without danger of degradation through thawing.

Value: HemaSpot™ has the ability to perform round-the-clock blood samples by the patient. Chronobiology, the 24-hour day/night-activity/rest biologic rhythm cycles, is a key factor in medical diagnosis and treatment. Involved in almost all mammalian functions, biologic rhythms are controlled by circadian CLOCK (Circadian Locomotor Output Cycles Kaput) genes and disruption has been linked to disease onset, severity of disease symptoms, diagnostic test result variability, and even the body’s response to drug therapy. For example, circulating levels of hormones, cytokines, catecholamines, leptin and many additional biomarkers vary with time and dictate complicated biological functions (Figure 1). One major impediment in doing human chronobiological research is the difficulty in collecting round-the-clock blood samples at multiple timepoints. For a venous blood draw, the only way to accomplish this is with overnight stays at a clinic which can be extremely inconvenient for the subject and costly for the researcher.

Figure 1. Human Circadian Time Structure (Wikipedia, http://en.wikipedia.org/wiki/Circadian_rhythm)

HemaSpot™ can overcome these limitations because a subject or person, at home, can literally take a blood sample anywhere and at any time. Complicated phlebotomy procedures or clinical stays aren’t needed and the samples can be stored with the subject at room temperature until they are ready to mail them in for laboratory analysis. In addition, the iPhone app, HemaScan™ (currently under development), means that date, time, and location are automatically captured at the time of the sampling, increasing the accuracy of the data. For these applications as well as for diagnostic testing, blood sampling could occur at the optimum times required by the study for better results and not dictated by the convenience of the clinic. “This is exactly the tool that our field has been waiting for,” according to Dr. Mike Smolensky, Editor of Chronobiology International Journal.

Value: Ease of blood sampling compared to venipuncture, convenient storage options and small volume capacity make the HemaSpot™ device ideal for rodent and other toxicological species blood sampling. Pre-Clinical testing refers to testing that typically occurs before proceeding to human clinical trial work.  In the drug development industry, this is usually a combination of in vitro, or test tube testing, as well as animal testing. Typically, the goal of this process is to evaluate the potential risk of a drug candidate before performing first-in-man studies.  Much of the animal testing, due to costs and regulatory issues, is done in rodent species with dog and monkey considered more relevant to human but more expensive and difficult. Animal testing, especially rodent blood draws, follows complex protocols and is an important procedure in biomedical research.  Manipulating small animals, such as mice, includes trying to remove blood through venipuncture, and keeping the samples organized. HemaSpot™ and HemaForm™ are ideal solutions for streamlining the process.   As little as 40uL of a blood sample can be used and because each HemaSpot™ and HemaForm™ is barcoded, data can be recorded and read with a smartphone.  Blood sampling can be done with a simple prick instead of a cumbersome needle/syringe/collection tube setup. Once the blood sample is spotted, the HemaSpot™ device is immediately closed and scanned to log in the time, date, location, and the animal.  The closed device is secure and rugged so dropping it won’t mean a lost blood sample and the quick drying time means the sample is stable at room temperature for years.  In other words, no other stabilizers or additives need to be added and temporary storage ice buckets are no longer a part of the blood draw procedure.  Because the process is streamlined with a minimization of potential errors, the technicians can focus on the animals. Given the difficulties in sampling large numbers of animals and running the risk that blood samples may be lost, compromised, or contaminated during the process, HemaSpot™ represents an easier, safer, and more efficient way to do animal blood collection work.

Value: HemaSpot™ delivers cost savings due to reduced travel and need for expertise, as well as better accuracy and higher patient satisfaction. Problem: Patient recruitment and retention in clinical trials is widely recognized as a leading bottleneck in drug development pipelines and a key contributor to increased drug development costs. The number of qualified patients is severely limited by location restraints; applicants need to live within about 20 miles of a trial center to enable routine blood draws. Even when a patient lives within an appropriate region, surveys of patients show that the time and effort needed to visit a trial site many times on a fixed schedule make them less willing to participate or remain in a study (Roehr, B., BMJ 2011; 342:d3722). Delays due to poor patient recruitment or retention can cost in excess of $35,000 a day per study protocol and increase the time-to-market for a drug (Outsourcing in Drug Development, 2nd Edition, Kalorama). Solution: HemaSpot™ can increase patient recruitment and retention by allowing the patient to take samples from home or any remote location, thus greatly increasing the pool of patients while reducing the inconvenience of multiple trips for blood draws. Remote sampling capability may increase participation of rural and elderly patients who are traditionally under-represented due to poor access to trial sites. Sampling events can be documented by scanning a bar code by mobile phone which creates a time, date and location stamp as well as patient and study information. In addition to cost savings due to more rapid completion of trials and shortening the time to commercialization, significant cost reductions can also be realized for:

• Fewer clinical sites with reduced IRB and validation costs
• 75% reduction in personnel and infrastructure for sample collection
• Lower recruitment and retention costs
• Reduced travel stipends and hotel costs for remote patients
• Improved sample stability
• Sample shipping and storage at ambient temperature

Even for sample collection at traditional clinical sites, the HemaSpot™ device can greatly reduce costs and streamline procedures by:

• Delivering a time savings of >85%; 5 minutes for HemaSpot™ sampling vs 45 minutes for traditional methods
• Reducing opportunities for contamination
• Minimizing labeling errors
• Offering less infrastructure and personnel requirements (75% reduction)
• Bringing higher patient satisfaction; a recent study showed that 100% of patients preferred finger stick over venipuncture (Vidal-Taboada, JM et al., BMC Medical Genetics 2006, 7:451)

Taken together, these advantages will significantly reduce costs for clinical trial operations. In the words of a Chief Scientific Officer from a CRO, HemaSpot™ “…would be huge for us”.

Value:  Greatly increase access to diagnostic testing and reduce health disparities for underserved and resource-limited populations by predicting, detecting and monitoring chronic diseases such as diabetes, HIV and cardiovascular disease. People who are home-bound or live in remote and rural areas sometimes lack transportation for both routine and needed medical screening.  In addition, there are those who cannot take time off from work, finding it difficult to travel to a lab in order to have their blood drawn for a diagnostic test. HemaSpot™ makes it possible for individuals to take their own sample with a finger stick, whether at home or at work, and mail the sample to the testing lab.  This simple collection method can make it much easier and significantly cheaper to get not only routine check-ups but also get life-saving blood tests done for this underserved population. Treatments for healthcare are largely determined by diagnostic test results and access to testing is critical for predicting, diagnosing and treating chronic diseases like diabetes and cardiovascular disease.   Compared to traditional methods of blood collection such as venipuncture, HemaSpot™ represents an efficient solution for the continuum of care. HemaSpot™ will “revolutionize blood sampling” according to a medical association officer and will be “less invasive, less painful” than venipuncture for the elderly according to a nursing home facility director. HemaSpot™  simplifies the blood sampling process for anyone from any location and at any time.  Taking advantage of this process can have two major impacts on healthcare, healthcare providers, and patients alike. First, as mentioned, the device can help inequalities in care and patient monitoring by improving access to diagnostic testing that has been historically difficult or ignored for the elderly, rural, homebound or economically disadvantaged. This is highly desired by the medical health field as diagnostic tests have been shown to significantly improve health outcomes and decrease healthcare costs by lowering complications and hospitalizations. The second impact will be on the time intervals with which samples can be taken, or in the research world, known as chronobiology.  With a device that can sample anywhere and anytime, it means that around-the-clock blood sampling can be done.  For instance, the device enables taking samples after meals or before bed, or, at time intervals after dosing with a medication. While conceptually straightforward, demonstration of HemaSpot™  blood sampling and higher throughput analysis by a central lab has the potential to “completely change the way we do clinical science” as suggested by Dr. Ramon Hermida, MD, U Vigo, Spain.  This model could vastly improve access to medical diagnostic testing for resource-scarce environments and underserved populations in both developed and developing nations including remote, home-bound and socioeconomically disadvantaged patients.