Austin, Texas-based medical device company Spot On Sciences, Inc. , with improved methods for collecting and storing blood samples under active development, has announced United States Patent and Trademark Office has issuance of US Patent 9040236 for the company’s remote controlled and monitored biological fluid sampling and storage apparatus. Spot On Sciences has exclusive rights to the patented technology and is developing additional medical research and testing devices devices for collection of other types of biologicals samples such as urine, saliva and tissue.
Spot On Sciences, Inc.’s initial HemaForm and HemaSpot products enable remote blood sample collection solutions for multiple markets, including clinical trials, biobanking, home-based wellness testing, military field medicine and population studies.
The mission of Spot On Sciences, founded in early 2010 by the company’s now President and CEO Dr. Jeanette R. Hill, is to change existing paradigms in a mature market with innovative technologies that simplify processes, save time and reduce costs, and to improve medical testing access for elderly, shut-in, rural, and economically disadvantaged patients by enabling easy remote biological sample collection and shipment.
HemaSpot, the first biological fluid collection and storage device developed by Spot On Sciences scientists, presents an alternative to traditional venipuncture sampling methods. The HemaSpot device, based on dried blood spot (DBS) technology that is best known for newborn screening, improves sample quality, simplifies collection, and facilitates stable sample storage at room temperature. By contrast, samples collected using venipuncture generally require a trained phlebotomist, sterile equipment, specialized needles and collection tubes, and refrigeration for storage. Unsurprisingly, interest in DBS has been increasing with recent and ongoing improvement in DBS analysis methods.
Traditional DBS involves a multi-step process that is subject to errors from moisture, contamination, and sample loss. HemaSpot’s innovative design pro-actively addresses these problems, and streamlines the entire process. Common disease markers can be measured including proteins, nucleic acids and small molecules.
The relatively simple HemaSpot device is easy to use for self-sampling and robust storage/shipping of blood samples at ambient temperatures. A finger stick is used to collect and dry blood within a protective HemaSpot cartridge.
Once dried, the sample is stable at ambient temperatures, allowing for safe and economical shipment to a laboratory test site for analysis through the US Postal Service or general parcel delivery services. Dried blood spots are accepted by the US Postal Service as safe, and may be shipped by standard mail if secured within a secondary container before placing inside the mailer. The HemaSpot™ device is considered the secondary container and renders the blood sample safe and secure after closing.
HemaSpot’s quality of allowing anyone to take a blood sample anywhere and at any time enables opens potential for medical research and testing not previously possible .
Patent pending HemaSpot is a cartridge containing an absorbent paper and a desiccant, and covered with an application surface containing a small opening to allow for blood entry. Once two drops of blood from a finger stick by lancet are applied (see Usage) and the cartridge closed, and the desiccant rapidly dries the sample, which is ready for immediate shipping or storage. The moisture-tight cartridge and tamper-resistant latch assure that the sample remains uncompromised. The entire device has approximately the footprint of a credit card and is about 1 cm tall when closed
Each HemaSpot device can be labeled with a unique bar-code for identification of samples using standard bar code readers such as smartphones or laboratory scanners (Figure 2). Bar-code recognition by a smartphone application is currently under development, and may be also be used to alert a receiving lab that a time and date-stamped sample has been shipped along with respective patient information.
Upon arrival at a testing lab via standard, non-refrigerated shipping channels, the cartridge is opened with a provided tool and a portion of the blood sample removed for analysis. HemaSpot contains Spot On
Sciences’ proprietary HemaForm absorbent paper for improved sample quality and handling. The remainder of samples can be safely stored at ambient temperature for additional testing or for long term biorepository storage in the moisture-tight cartridge.
HemaSpot incorporates all of the dried blood spot (DBS) technology’s benefits while greatly simplifying specimen collection and concurrently improving sample quality. A comparison of blood collection methods is shown in Table 1.
By enabling remote blood sampling, HemaSpot has a range of potential applications associated with healthcare and medical research. “What we did is design a device that makes it almost foolproof to get a blood sample, and any of us can take a sample at home,” says Dr. Hill. “We are confident that Spot On Sciences’ patent will provide our products with long-term market exclusivity. This patent is just the first step in disrupting the way laboratory tests are done effectively changing the way we view healthcare.”
Dr. Hill was a co-founder of Biochemical Resources, a 2011 Finalist for the Cartier Women’s Initiative Award for women entrepreneurs, is a Defense Advanced Research Projects Agency (DARPA) award recipient, and has more than 20 years of experience in pharmaceutical research
Prior to the USPTO patent announcement, HemaSpot had received the “Conformite Europeenne” ( CE mark — formerly EC mark — mandatory for certain products sold within the European Economic Area (EEA) indicating ability to meet safety, health and environmental protection requirements and enabling free movement of the product within the European market. HemaSpot has also been granted patent 61/377,323 by the Commonwealth of Australia.
Spot On Sciences has been recognized with several awards including the SXSW Interactive Accelerator (2013), RISE Global Pitch Competition (2013), 1776 Challenge Cup– Health category (2014), the Astia/WeOwnIt Venture Competition (2014) and named North America champion in the Kauffman Foundation’s Global Pitch Competition (2014).
For more information visit the company’s website at:
Spot On Sciences
Spot On Sciences