WORLD AIDS DAY 2015 ON DECEMBER 1ST

As I reflect on the post I wrote three years ago, it is with mixed feelings that I once again blog about World AIDS Day. There is part of me that is relieved to see that the media is still covering stories about HIV (no burnout yet!) but the spotlight appears to be about well-known celebrities such as Rock Hudson, Greg Louganis, and Arthur Ashe. Charlie Sheen’s recent announcement that he, too, is living with HIV has also helped to trigger new discussions.

But, what about the real HIV/AIDS story…the story of how it continues to infect innocent mothers and babies of the world? Globally, the UN’s Millennium Goals for 2015 (MDG 6) were missed. The target of halting and beginning to reverse the spread of HIV/Aids by 2015 has not been met, although the number of new HIV infections fell by around 40% between 2000 and 2013.

Sadly, despite education, awareness, better technology and good drugs, the virus continues to be on the rise in the U.S. among certain populations and certain age/minority groups.

This month the CDC reported that in the U.S. the sexually transmitted disease (STD) epidemic is worsening and that cases of chlamydia, gonorrhea and syphilis all increased in 2014*. A CDC spokesperson stated, “America’s worsening STD epidemic is a clear call for better diagnosis, treatment, and prevention.”

The good news is that there was a global reduction in HIV infection in 2015 and, according toPEPFARandMDG, there has been improvement in access to care and treatment with ~ 13.4 Million people on ARVs as noted in the MGD6 goal. Newer ARV combinations and prophylactic drugs are working well. The even better news is that progress has been made with mothers, children, and babies as shown in the following stats:

  • 43% decline in new infections among children in 21 priority countries
  • 7 out 10 HIV pregnant women received ARV’s to prevent mother-to-child transmission
  • 6 out of 10 mothers or their children received ARV’s while breastfed to prevent transmission

As we look to future World AIDS Days, I am hopeful that next year’s post will deliver more good news showing progress towards ending this terrible epidemic.

*People who get syphilis, gonorrhea, and herpes often also have HIV, or are more likely to get HIV in the future. http://www.cdc.gov/std/hiv/stdfact-std-hiv.htm

ARE YOU HEART HEALTHY? iT’S CHOLESTEROL EDUCATION MONTH!

September is National Cholesterol Education Month and I was asked to look into whether this heart health marker can be measured from dried blood spots. But first I needed to understand what is actually measured when cholesterol levels are reported.

Everyone knows LDL cholesterol, often referred to as the “bad” cholesterol, and HDL cholesterol, referred to as the “good” cholesterol. But what exactly are these substances. It turns out that LDL and HDL are various forms of lipoproteins which transport cholesterol through the blood system. Cholesterol itself is a necessary component of cell membranes and getting this to the cells is a function of the low density lipoprotein (LDL). However, too much of this species has been found to lead to coronary heart disease. Thus the need to monitor.

The CDC has published its guidelines(1) for the analysis of the various forms of cholesterol in plasma. Total cholesterol (TC) is determined by a modification of the original Abell-Kendall method reported in 1952(2).

HDL-cholesterol (HDL-C) is determined through a series of steps, including a 16 hour ultracentrifugaton, selective precipitation of non-HDL-C lipoproteins using manganese and heparin, and then the remaining cholesterol is quantitated by the Abell-Kendall method mentioned above.

LDL-cholesterol (LDL-C) is calculated from the beta-quantitation; LDL-C = TC – HDL-C, where TC in this case is the total cholesterol measured in the bottom fraction after the HDL-C ultracentrafuge step above.

However, most laboratories have been reporting LDL-C concentrations using the Friedewald equation(3) (see Eq. 1 below). This procedure skips the ultracentrifugation step and requires a) determining the total cholesterol present in plasma, b) obtaining the HDL-C by precipitation of all non-HDL-C lipoproteins and c) measuring the triglycerides (TG) concentration. The triglyceride concentration is used to estimate other cholesterol containing components in plasma, which has historically been found to be 5 to 1. The Friedewald equation is:

Eq. 1) LDL-C = TC – HDL-C – 0.2xTG

The current CDC standard recommends a GC-MS method be used for measuring TG concentration. This method involves hydrolysis of the fatty acid esters of glycerol, evaporation of solvent, derivatization, extraction and analysis by GC-MS.

So how is this working for dried blood spots? There are a number of methods listed in the DBS database at Spot On Sciences’ web site. Some involve GC-MS, some used the cholesterol oxidase/p-aminophenazone method and triglycerides by the glycerophosphate oxidase-peroxidase/aminophenazone method but an equal number involve LC-MS/MS. One thing to notice though is that these methods measure only the total cholesterol present in the dried blood spot. There is as yet no report of a separation of the various complexes that are important to the individual.

http://www.nhlbi.nih.gov/files/docs/guidelines/atglance.pdf

SPOT ON SCIENCES SELECTED FOR FIRST-EVER WHITE HOUSE DEMO DAY

WASHINGTON, DC – Today, President Obama will host the first-ever White House Demo Day focused on inclusive entrepreneurship, welcoming startup founders from diverse walks of life and from across the country to showcase their innovations.

The President will also announce new public- and private-sector commitments that promise to provide more Americans with the opportunity to pursue their bold, game-changing ideas.

Read more here.

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SPOT ON SCIENCES AWARDED US PATENT FOR BIOLOGICAL FLUID  COLLECTION DEVICE

Spot On Sciences, Inc., a medical device company that is actively developing innovative methods for collecting and storing blood samples, today announced that the United States Patent and Trademark Office has issuedUS Patent 9040236covering biological fluid sampling and storage apparatus for remote use. Spot On Sciences has exclusive rights to the patented technology and has additional devices in development.

The biological fluid collection and storage device, developed by scientists at Spot On Sciences, presents an alternative to traditional venipuncture. The device, called HemaSpot™, is based on dried blood spot (DBS) technology which is best known for newborn screening. HemaSpot™ improves sample quality, simplifies collection, and allows for stable sample storage at room temperature. In contrast, samples collected by venipuncture generally require a trained phlebotomist, sterile equipment, specialized needles and collection tubes in addition to refrigeration for storage. Interest in DBS has been increasing as methods of analysis continue to improve.

“We are confident that Spot On Sciences’ patent will provide our products with long-term market exclusivity,” said Jeanette Hill, PhD, President and CEO of Spot On Sciences. “This patent is just the first step in disrupting the way laboratory tests are done effectively changing the way we view healthcare.”

The single-use HemaSpot™ device uses a finger stick to collect and dry two drops of blood within a protective cartridge. Once dried, the sample is stable at room temperature and can be safely and easily shipped to a diagnostic test site for analysis. Traditional DBS involves a multi-step process that is subject to errors from moisture, contamination, and sample loss. HemaSpot’s™ innovative design addresses these problems, streamlining the entire process. Common disease markers can be measured including proteins, nucleic acids and small molecules.

Prior to the USPTO announcement, HemaSpot received the CE mark indicating ability to meet safety, health and environmental protection requirements enabling free movement of the product within the European market. HemaSpot has also been granted patent 61/377,323 by the Commonwealth of Australia.

About Spot On Sciences

Spot On Sciences, Inc., located in Austin, Texas, is a medical device company that is actively developing innovative methods for collecting and storing biological fluid samples. The company’s current product, HemaSpot™, allows for simplified blood sample collection and storage for dried blood spot (DBS) testing. Spot On Sciences aspires to change existing paradigms in this mature market with technologies that simplify processes, save time and reduce costs. The company has been recognized with many 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 www.spotonsciences.com.

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SPOT ON SCIENCES ANNOUNCES RESEARCH COLLABORATION WITH THE MILITARY HIV RESEARCH PROGRAM FRO DEPLOYED TROOPS

Austin, TX—Feb 12, 2015 – Spot On Sciences has announced a collaboration with the US Military HIV Research Program (MHRP), Walter Reed Army Institute of Research, to support a study for detecting infectious pathogens such as HIV, hepatitis B and hepatitis C and mosquito-borne infections such as dengue, West Nile and chikungunya virus in deployed troops. MHRP seeks to evaluate methods for efficient collection, preservation and transportation of high quality biospecimens, such as blood, from remote locations with limited resources.

Spot On Sciences’ blood sampling device, HemaSpot, will be evaluated for use for blood collection in the field for biosurveillance studies. HemaSpot is based on dried blood spot (DBS) sampling, a proven technology that has been around for 50 years. The patent-pending device allows blood sample collection to be performed in remote settings, improves sample quality, simplifies collection, and allows for stable sample storage for years at room temperature, all characteristics which facilitate acquisition of blood samples in the field.

“The HemaSpot device was invented to address critical issues surrounding remote blood sampling, making it potentially ideal for use in military settings. We look forward to participating in this groundbreaking study,” stated Shelley Hossenlopp, Senior Director of Business Development for Spot On Sciences. “I believe the device could play an important role in the collection of critical biological samples from the field.”

The Walter Reed Army Institute for Research (WRAIR) conducts research to diagnose, prevent, and treat infectious diseases, which often pose a unique threat to troops deployed to disease-endemic areas of the world. Screening of soldiers for infectious pathogens requires venipuncture, a process which is not practical in resource-scarce environments. Once whole blood is collected, the next significant challenge is sample transportation under appropriate conditions. WRAIR will investigate whether HemaSpot, the DBS sample, facilitates improved specimen integrity for infectious pathogen screening due to its potential ease of use and stability during transportation. MAJ Brook, the principal investigator of the study at WRAIR added, “The US military deploys troops throughout the world for peacekeeping and military missions, exposing soldiers to innumerable infectious diseases. The proposed study will address whether HemaSpot allows efficient collection, preservation and transportation of sufficiently high quality biospecimens for surveillance, epidemiology, and/or diagnostic testing of remote or vulnerable populations.” Additional funding for this project is provided through a Defense Health Program Grant.

About the U.S. Military HIV Research Program (MHRP) at the Walter Reed Army Institute of Research

The U.S Military HIV Research Program (MHRP) at WRAIR seeks to protect the warfighter and serve the global community by reducing the risk of HIV infection worldwide. Research efforts encompass threat assessment and epidemiology, HIV diagnostics, vaccine development and testing, and therapeutics research. While its primary focus is to develop a globally effective HIV vaccine, MHRP is also a leader in development of diagnostic countermeasures and provides effective prevention, care and treatment programs in parts of Africa where they conduct research. For more information, visitwww.hivresearch.organdwww.wrair.army.mil.

About Spot On Sciences

Spot On Sciences, Inc., located in Austin, Texas, is a medical device company that is actively developing innovative methods for collecting and storing biological fluid samples. The company’s current product, HemaSpot™, allows for simplified blood sample collection and storage for dried blood spot (DBS) testing. Spot On Sciences aspires to change existing paradigms in this mature market with technologies that simplify processes, save time and reduce costs. The company has been recognized with many 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 the Kauffman Foundation’s Global Pitch Competition (2014). For more information visit the company’s website atwww.spotonsciences.com.

Press Contacts

Sue Leininger
Spot On Sciences
512-827-9627
sueleininger@spotonsciences.com

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SPOT ON SCIENCES CROWNED CHAMPION OF ‘GET IN THE RING: THE NORTH AMERICAN STARTUP CLASH’, HOSTED BY THE KAUFFMAN FOUNDATION

KANSAS CITY, Mo. (Nov. 10, 2014) — An Austin, Texas, medical device startup aiming to revolutionize the collection of blood samples without the use of a single needle delivered the knockout punch in the final round of “Get in the Ring: The North American Startup Clash,” hosted by the Kauffman Foundation.

Spot On Sciences’ founder and CEO, Jeanette Hill, sparred verbally with seven other finalists for the title of North American champion, a $10,000 prize and an expense-paid trip to the Netherlands to compete in the global finals.

Maieutic, an Oakville, Ontario, startup represented by its CEO and cofounder, Asif Khan, took home runner-up honors and a $5,000 prize. The company has developed a unique die- and surface-casting technology with a real-time programmable surface to help manufacturers eliminate costly downtime.

Interestingly, Maieutic happened to go head-to-head against Spot On Sciences during its initial clash but was rescued from elimination as the “judges’ save,” shortly before the winners were announced.

In addition, in-person attendees and online viewers cast a vote for “Audience Choice,” which went to FitBark from Kansas City, Mo. Founded by Davide Rossi, FitBark is the world’s smallest wireless activity monitor for dogs and was awarded $1,000.

More than 250 people attended the primetime event Nov. 7 at the historic Midland Theatre in Kansas City, Mo., while nearly 100 more watched online via live webcast. A recording of the event is available to view at www.Kauffman.org/GITR.

The international judges for this final round of the competition were:

  • Devon Brooks (Canada), cofounder of Blo, North America’s original blow dry bar;
  • Hernán Fernández (Mexico), director and cofounder of Angel Ventures Mexico, the first professionally managed angel investor network in the country;
  • Mark Hasebroock (United States), serial entrepreneur and founder of Dundee Venture Capital;
  • Leslie Jump (United States), founder and CEO of Startup Angels and a board member of UP Global; and
  • Paul Kedrosky (United States), cofounder and managing partner of SK Ventures and Garibaldi Capital Advisors, entrepreneur, and writer.

The five other finalists were Advolve Media (Winnipeg, Manitoba), Hydrobee (Seattle), Identified Technologies (Pittsburgh), PPLCONNECT (Montreal) and The Rumie Initiative (Toronto).

“We’re thrilled that our at-home blood-collection device, HemaSpot, has been recognized for impacting global healthcare,” said Hill of Spot On Sciences. “We were blown away by the caliber of pitches by the other Get in the Ring combatants and feel honored to have won.”

She explained that while more than 80 percent of healthcare decisions are based on diagnostic testing, obtaining blood samples is difficult — especially for individuals who are homebound, elderly or in remote areas. Spot On Sciences, therefore, enables anyone anywhere to take an effective blood sample with only two drops of blood, without the need for laboratory equipment or personnel.

Event sponsors for Get in the Ring: The North American Startup Clash were Sprint and Combat Brands; media partners were Inc., Marketplace from American Public Media and Kansas City PBS station KCPT. Visitwww.Kauffman.org/GITR for more information.

Hill now travels expense-paid to Rotterdam, the Netherlands, to compete against the best startups in the world. Winners from eight global regions (North America, South America, Africa, Asia, Eastern Europe, Southern Europe, Western Europe and the Middle East) will compete for a chance at prizes, exposure and the opportunity for angel funding.

The global Get in the Ring finals will be held on Nov. 21 and is one of the signature events of Global Entrepreneurship Week.

For more information about the global Get in the Ring competition, visit www.getinthering.co, and follow Get in the Ring on Twitter @GITR_GEW and www.facebook/getinthering.gew.

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HEMASPOT POISED TO TACKLE THE EBOLA CRISIS AND DISASTER MEDICINE

Early in 2014, the Spot On Sciences’ team was asked to contribute content for a book with a pretty serious title —Global Point of Care: Strategies for Disasters, Emergencies, and Public Health Resilience. This soon-to-be-released publication addresses point-of-care testing (POCT) needs in global emergency and disaster settings. The subject being tackled by respected experts in the field, Drs. Kost and Curtis, is exceptionally relevant in light of recent news coverage of the Ebola breakout.

One way to improve healthcare resources and enhance standards of care is to include biosurveillance efforts to help monitor public health in stricken areas. So, how does HemaSpot fit into this strategy?

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What is Biosurveillance?

The DoD defines biosurveillance as “…gathering, analysis and interpretation of data related to disease activity and threats to human and animal health to achieve early warning, detection and situational awareness.” The goal, of course, is to secure early detection and prediction of biological events no matter what their cause. A few years ago the focus was on H1N1 swine flu and West Nile virus. Now the world’s attention is on the devastation being caused by the Ebola virus and POCT has had to adapt.

HemaSpot Can Make a Difference in Biosurveillance

Medical care under disaster situations relies heavily on the availability of on-site clinical diagnostic testing. However, access can be severely limited by difficulties in collecting and analyzing biospecimens in the field. Venipuncture remains the most commonly used blood collection technique for most biosurveillance and diagnostic testing but nonsterile and biohazardous environments can cause difficulties in safely collecting and transporting clean and noncontaminated samples. Dirty, nonsterile needles and accidental needle sticks to healthcare workers are also a concern.

Spot On Sciences’ blood sampling device, HemaSpot, simplifies and allows nearly foolproof blood sampling from any location and at any time. This simple but powerful concept will have a big impact on healthcare by improving access for biosurveillance and diagnostic testing, especially for patients in remote, low-resource, or disaster areas by allowing easy on-site sample collection, transport, and/or shipment. High-quality samples can be collected and preserved with HemaSpot by first responders or medics under austere conditions and analyzed by POC methods on-site or transported to a central lab in backpacks or via regular post.

We’re learning more about opportunities for HemaSpot’s potential role in tracking dangerous diseases. Use of HemaSpot for sample collection in the field can significantly increase access to Ebola screening and testing for an affected population, and provide critical clinical information rapidly for medical care in emergency situations. We’ll keep you posted on future developments as we all look for answers that address this serious situation.

SPOT ON SCIENCES AWARDED NIH GRANT FOR GROUNDBREAKING CHRONIC DISEASE RESEARCH

Austin, TX August 25, 2014: Spot On Sciences, Inc., an Austin-based medical device company, has received a six-month, $150,000 Small Business Innovation Research (SBIR) Phase I award from the National Institutes of Health (NIH) to demonstrate the company’s HemaSpot device for collection and analysis of time-relevant blood samples for medical research in chronic disease and population studies.

Recent studies completed by Dr. Ramon Hermida from the University of Vigo, Spain have shown that the survival of at-risk patients is increased up to 5-fold by simply taking blood pressure medications at bedtime instead of morning. Research to further investigate the causes, likely due to the body’scircadian rhythm, has been limited by the difficulty in obtaining blood samples at specific time points such as early morning and late evening. Previously a certified phlebotomist and travel to a laboratory for venipuncture blood collection was required to get a blood sample.

The HemaSpot™ devices, developed by scientists at Spot On Sciences, uses a fingerstick to collect blood samples at home. Based on dried blood spot (DBS) technology, which is best known for newborn screening, the patented device improves sample quality, simplifies collection, and allows for stable sample storage at room temperature. Obtaining multiple samples in a single day to measure disease biomarkers that change according to daily circadian rhythms can provide valuable data for predicting, diagnosing and treating chronic diseases such as diabetes, kidney and cardiovascular disease.

According to Dr. Michael Smolensky, professor of biomedical engineering at the University of Texas-Austin and past editor of the academic journalChronobiology International, HemaSpot “… is the tool we’ve been waiting for.” Smolensky, who is also collaborating with Dr. Hermida and Spot On Sciences for this study, stated that “…HemaSpot sets the stage for large-scale, low-cost patient studies in blood pressure and hypertension that we hope to initiate next year.” Spot On Sciences’ founder, Dr. Jeanette Hill, commented “We are very excited to work with Drs. Hermida and Smolensky, well known experts in the chronobiology area, on this study. Discovering the underlying causes of the intriguing findings of Dr. Hermida’s study can point to new diagnostic tests and treatments for high burden diseases. “

The single-use HemaSpot™ device uses a finger stick to collect and dry two drops of blood within a protective cartridge. Once dried, the sample is stable at room temperature and can be safely and easily shipped to a diagnostic test site for analysis. Traditional DBS involves a multi-step process that is subject to errors from moisture, contamination, and sample loss. HemaSpot’s™ innovative design addresses these problems, streamlining the entire process. Common disease markers can be measured including proteins, nucleic acids and small molecules.

“We’ve known for a long time that the body’s circadian time structure, i.e., circadian rhythms, can have a significant effect on day-night variation in the symptoms intensity of disease and effectiveness of medication. HemaSpot makes it possible for new research into this intriguing area of medical chronobiology,” said Dr. Hill.

About National Institutes of Health (NIH)

NIH is a biomedical research facility primarily located in Bethesda, Maryland, USA. An agency of the United States Department of Health and Human Services, it is the primary agency of the United States government responsible for biomedical and health-related research.

About Spot On Sciences

Spot On Sciences, Inc., located in Austin, Texas, is a medical device company that is actively developing innovative methods for collecting and storing biological fluid samples. The company’s current product, HemaSpot™, allows for simplified blood sample collection and storage for dried blood spot (DBS) testing. More than 20 billion blood tests are performed annually worldwide with in vitro diagnostics showing sales of an estimated US$28.6 billion worldwide. Spot On Sciences aspires to change existing paradigms in this mature market with technologies that simplify processes, save time and reduce costs. The company has been recognized with many awards including the SXSW Interactive Accelerator (2013), RISE Global Pitch Competition (2013), 1776 Challenge Cup – Health category (2014) and the Astia/WeOwnIt Venture Competition (2014). For more information visit the company’s website atwww.spotonsciences.com.

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