Product Applications

HemaSpot™ Blood Collection Device Has Multiple Medical Testing and Research Applications

For Research Use Only. Not For Use in Diagnostic Procedures.

HemaSpot is a simple to use patented device for blood sampling and robust storage/shipping of blood samples at ambient temperatures.  Experts in the field are describing HemaSpot as “a vast improvement,” “a game changer” and “revolutionary.”

Potential applications for HemaSpot are described below representing innovations for medical research that were not feasible – until now.

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. Biomarker screening 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. biorepository 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™ offers the ability to perform round-the-clock blood sampling. Chronobiology, the 24-hour day/night-activity/rest biologic rhythm cycles, is a key factor for health. 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. 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, blood sampling could occur at the optimum times required by the study for better results and not dictated by the convenience of the testing facility. “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. 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”.