From point-of-care diagnostic tests to ancestral DNA home-testing, this company’s spit tubes are used by more medical laboratories than any other brand
Most clinical laboratory specialists know that OraSure Technologies of Bethlehem, Pa., was the first company to develop a rapid point-of-care DNA diagnostic test for HIV back in the 1990s. This was a big deal. It meant physicians could test patients during office visits and receive the results while the patients were still in the office. Since many patients fail to follow through on doctors’ test orders, this also meant physicians were diagnosing more patients with HIV than ever before.
Today, OraSure is the dominant company in the spit tube
industry. OraSure claims its tubes contain patented chemical preservatives that
can maintain the specimen’s integrity for up to two years at room temperature.
That’s a long time. And this one feature has made OraSure popular with
direct-to-consumer (DTC) genetic home-test developers.
OraSure provides nearly all of the specimen receptacles used
by individuals searching for their ancestral roots. It’s estimated that about
90% of the DTC genetic-testing market uses the company’s spit tubes. This is
partly because OraSure makes the only tubes approved by the US Food and Drug
Administration (FDA) for home DNA-testing purposes.
“The FDA approval gives customers confidence,” Mark Massaro, Managing Director, Senior Equity Analyst at investment bank Canaccord Genuity Group, told Bloomberg. “That, and they can preserve saliva for a long time.”
The OraSure spit tube above contains a patented mix of chemicals that can maintain saliva’s integrity for up to two years at room temperature. This is critical for ensuring specimens arrive at medical laboratories in usable condition to produce accurate test results. (Photo copyright: Zhongjia Sun/Bloomberg Businessweek.)
Spit, Close, Recap, Send
To use the saliva-testing DNA kits, an individual first
spits into the tube and then snaps the cap on the tube shut. This action
perforates a membrane which contains a patented, chemical mix of preservatives.
These chemicals help preserve the sample and minimize contamination from
non-human DNA that may be present.
“You’ve got to make it as easy as possible for a person to
spit in the tube, close the tube, recap the tube, and send it to you without
any variation,” Stephen
Tang, PhD, President and Chief Executive Officer at OraSure, told Bloomberg.
Saliva samples are very susceptible to environmental factors
like temperature and are extremely time sensitive. They need to be properly
handled and stored to prevent any degradation and ensure the most accurate test
results. Once in the spit tube, a saliva sample can last more than two years at
room temperature, according to the company.
“That’s the secret,” Tang stated. “Saliva is not pure. It’s
got a lot of bacteria and other stuff swimming in it.”
OraSure reported the company made $182 million in revenue in
2018, with about $20 million of that amount being profit. DNA Genotek, Inc., a subsidiary of OraSure
designed the T-shaped spit tubes being used for consumer-DNA testing kits.
Other Clinical Laboratory Uses for Specimen-Collection Devices
In addition to the consumer-DNA industry, OraSure’s tube technology is used in clinical and academic laboratory situations as well as in veterinary DNA testing. The company is focused on expanding the uses for their specimen-collection technology. They have recently begun using their technology to collect urine specimens for diagnosing sexually transmitted diseases and other conditions. OraSure also has added devices for feces collection, to better compete in the developing field of microbiome for gut bacteria analysis.
“We are all about the integrity of the sample collection,”
Tang says. “It’s a wide-open field.”
Ancestry Sued by OraSure
In 2017, Ancestry.com agreed to pay OraSure $12.5 million to
settle a lawsuit which alleged the company had copied OraSure’s patented DNA
testing technology to produce their own saliva-based DNA test.
According to the lawsuit, Ancestry.com purchased saliva test
kits from DNA Genotek in 2012 and 2013 for the purpose of collecting saliva
samples from their customers. In 2013, Ancestry.com filed for a patent of their
own for an improved variation of the kits reportedly without DNA Genotek’s
consent.
OraSure also has devices for substance abuse testing,
cryosurgical kits for the testing of skin lesions, and kits for forensic
toxicology.
Maintaining specimen integrity is critical to ensure lab
test results are accurate and reproducible. OraSure’s spit tube technology
solves the problem of preserving specimens while they are transported to
clinical laboratories and other pathology facilities.
Clinical laboratory leaders aiming for patient-centered care and precision medicine outcomes need to acknowledge that patients do not want to be in hospitals or travel to physician offices and patient care centers for blood tests. It can be inconvenient, sometimes costly, and often painful.
That’s why disease management methods such as remote patient monitoring are appealing to many people. It’s a big market estimated to reach $1 billion by 2020, according to a Transparency MarketResearch Report. The study also associated popularity of devices such as heart rate and respiratory rate monitors with economic pressures of unnecessary hospital readmissions.
But can remote patient monitoring be used for more than to check heart rates, monitor blood glucose, and track activity levels? Could such technology be effectively leveraged by medical laboratories for remote blood sampling?
Microsampling versus Dried Blood Collecting
Remote patient monitoring must be able to address a large number of diseases and chronic health conditions for it to continue to expand and gain acceptance as a viable way to care for patients in different settings outside of hospitals. However, as most clinical pathologists and laboratory scientists know, clinical laboratory testing has an essential role in patient monitoring. Thus, there is the need for a way to collect blood and other relevant samples from patients in these remote settings.
One promising approach is the development of new microsampling technology that can overcome past obstacles of dried blood collection. Furthermore, microsampling-enabled devices can make it possible for medical laboratories to reach out to the homebound to secure accurate and volumetrically appropriate samples in a cost-effective manner.
“One well-established fact in today’s healthcare system is that an ever-greater proportion of patients want clinical care that is less invasive and less intrusive,” noted Robert Michel, Editor-in-Chief of Dark Daily and The Dark Report. “Patients want to take more control over their treatment and be more effective at maintaining the stability of their chronic conditions, and often are happier than those who need to travel to have chronic conditions monitored. To meet this need there has been significant innovation, particularly in the area of remote blood sampling using microsampling technology.”
For decades, medical laboratories have tried various methods for acquiring and transporting blood samples from remote locations. One such non-invasive alternative to venipuncture is called dried blood spot (DBS) collecting. It involves placing a fingerprick of blood on filter paper and allowing it to dry prior to transport to the lab.
But DBS collected bio samples often do not contain enough hematocrit (volume percentage of red blood cells) for laboratories and clinical pathologists to provide accurate reports and interpretations. Reported reasons DBS cards have not penetrated a wide market include:
Hematocrit bias or effect;
Costly card punching and automation equipment; and,
Possible disruption to existing lab workflows.
Microsampling Technology Enables Collection of Appropriate Samples
Microsampling has to have the capability to enable labs to deliver quality results from reliable blood samples. This remote sampling technology makes it possible for phlebotomists to offer a comfortable collection alternative for homebound patients and rural residents. It also can be useful for physicians stationed in remote areas. Patients themselves can even collect their own blood samples.
Volumetric Absorptive Microsampling (VAMS) technology enables accurate samples of blood or other fluids from amounts as small as 10, 20, or 30 microliters, according to Neoteryx, LLC, of Torrance, Calif., the developer of VAMS. The technology is integrated into the company’s Mitra microsampler blood collection devices (shown above) in formats for patient use and for medical laboratory microsample accessioning and extraction. Click here to watch a video on the Mitra Microsampler Specimen Collection Device. (Photo copyright: Neoteryx.)
One company developing these types of products is Neoteryx, LLC, of Torrance, Calif. It develops, manufactures, and distributes microsampling products. Patients with the company’s Mitra device use a lancet to puncture their skin and draw a small amount of blood, collect it on the device’s absorptive tip, and then mail the samples to a blood lab for testing (Neoteryx does not perform testing).
“Technologies such VAMS are driving [precision medicine] in an extremely cost-effective manner, while only requiring minimal patient effort. Patients are taking a more active role in their healthcare journeys, and at-home sampling is supporting this shift,” stated Fasha Mahjoor, Chief Executive Officer, Neoteryx, in a blog post. (Photo copyright: Neoteryx.)
Advantages of Microsampling
Patient satisfaction survey data collected by Neoteryx suggest patients are comfortable with their role in blood collection:
70% are comfortable or very comfortable with the process;
86% say it is easy or very easy to use the Mitra device;
92% report it is easy to capture blood on the device’s tip;
55% of Mitra device users are likely or very likely to choose microsampling over traditional venipuncture; and,
93% noted they are likely or very likely to choose the device for child care.
A list of published studies describes certain advantages of VAMS technology that have implications for medical laboratories and clinical pathologists:
Microsampling has benefits and implications for therapeutic drug monitoring, infectious disease research, and remote specimen collection;
Dried blood microsamples from fingerstick can generate reliable data “correlating” to traditional blood collection processes;
Bioanalytical data collected with the Mitra device are accurate and dependable; and,
In a study for a panel of anti-epileptic drugs, VAMS led to optimized extraction efficiency above 86%, which means there was no hematocrit bias.
Learn More by Requesting the Dark Daily Microsampling White Paper
Rise of patient-centered care and remote patient monitoring;
Dried blood collection over the years and the hematocrit effect;
A look at microsampling and how it takes blood collection out of the clinic;
How Volumetric Absorptive Microsampling (VAMS) technology works;
Patient satisfaction data;
Research about microsampling including extensive graphics;
Launching new VAMS technology; and,
Frequently asked questions.
Innovative medical laboratory leaders who want to increase their understanding of how microsampling technology and remote patient monitoring relates to the goal of becoming a patient-centered lab are encouraged to request a copy of the white paper. It can be downloaded at no cost by clicking here, or placing https://www.darkdaily.com/how-to-create-a-patient-centered-lab-with-breakthrough-blood-collection-technology-9-2018/ into your browser.
AUSTIN, Texas (October 11, 2018) – Patient-centered care, also known as the “patient-centric” approach, represents a paradigm shift in how patients and providers think about the processes of treatment. Patient-centric care can lead to a better patient experience—which in turn leads to improved adherence and compliance. Improved patient compliance is an essential contributing factor to the ultimate goal—enhanced treatment efficiency and safety, and better clinical outcomes. More technicians, and the clinicians who rely upon them, are adopting patient-centric technologies to improve the quality of patient care and thus support enhanced clinical outcomes. Included in this proliferation of new technologies are those based on concept of remote patient monitoring (RPM).
“Remote patient monitoring makes many aspects of healthcare less invasive and intrusive for patients,” states Robert L. Michel, Editor-in-Chief of DarkDaily.com and The Dark Report. “Patients can participate in their care from the comfort and privacy of their own homes. Expenses associated with healthcare travel and long wait times are minimized. Patients take more control over their treatment, maintain greater stability, and are often happier than those who need to travel to have illnesses and chronic conditions monitored. This approach is proving so beneficial for both patients and healthcare professionals, it has touched off a new wave of innovation—that of remote blood sampling using microsampling technology.”
How Volumetric Absorptive Microsampling (VAMS™) technology was developed to solve for the limitations of the old, familiar versions of dried blood sampling technology
How new microsampling technology can be performed in such a way that, unlike older technologies, can ensure consistency and accuracy
What the new technology looks like, how it is configured, and design details that make it readily adoptable by labs, clinicians, and patients alike
Ways in which new microsampling technology facilitates a more patient-centric lab, and provides a user-friendly alternative to older, more intrusive or cumbersome methods
Technical evidence for efficacy substantiating the benefits and utility of new microsampling technology for applications such as therapeutic drug monitoring and remote specimen collection
A practical, step-by-step roadmap to new microsampling technology adoption, deployment, and success
The paper’s creator is Neoteryx, based in Torrance, CA—developer and manufacturer of the Mitra® microsampling device, which enables the collection of blood anywhere, at any time, by anyone. Mitra® facilitates an easier and more comfortable donor experience, particularly for children and the elderly. This novel technology also contributes to expanding participant outreach, eliminates costs and hassles associated with cold-chain shipping, and enables collection of blood specimens at home or in other settings outside of the clinic.
“How to Create a Patient-centered Lab with Breakthrough Blood Collection Technology: How to Save Time and Increase Profitability by Using Modular Technology to Improve Access Features, Automate Reporting & Expand Efficiencies” is part of the Dark Daily growing library of White Papers and other information resources tailored specifically for the needs of laboratory administrators, lab managers, pathologists, and lab industry consultants.
For additional information, Contact: Chris Garcia, 512-264-7103
About THE DARK REPORT
Established in 1995, THE DARK REPORT is the leading source of exclusive business intelligence for laboratory CEOs, COOs, CFOs, Pathologists and Senior industry executives. It is widely read by leaders in laboratory medicine and diagnostics. The Dark Report produces the famous Executive War College on Laboratory and Pathology Management every spring, which showcases innovations by the nation’s and globe’s leading laboratory organizations. Dark Daily is an Internet-based e-briefing intelligence service, read worldwide by thought leaders in laboratory and pathology management. Other well-known conferences conducted by THE DARK REPORT are Lab Quality Confab (on the use of Lean and Six Sigma methods in labs and hospitals) and Molecular Summit (on the integration of in vivo and in vitro diagnostics). THE DARK REPORT co-produces Frontiers in Laboratory Medicine annually in the United Kingdom; Executive Edge bi-annually in Canada; and The Business of Pathology bi-annually in Australia.
Breakthrough methods in blood collection technology have the ability to expedite your lab’s move to patient-centered care, as well as answer the challenges of changing remote patient requirements. The Dark Report is pleased to offer this FREE White Paper, an ideal resource for those interested in new microsampling technology—what it is, how it works, and how it can transform your lab.
Despite logistics and test volume concerns for laboratories, hospital-in-the-home services promise to reduce cost and improve quality of care for patients who might be negatively impacted by the noise, stress, and germs of busy hospitals
In April, The Washington Post highlighted the plight of 71-year-old Phyllis Petruzzelli—a patient with a weakened immune system suffering from pneumonia. Instead of admitting her into a noisy ward and exposing her to other germs and infection vectors, doctors at Brigham and Women’s Faulkner Hospital in Boston chose a different approach. They treated her in her home with a remote monitoring patch and in-home visits. Three days later, she was well and referred to her primary care provider for follow-up.
This is an example of the hospital-in-the-home model of clinical care. It is not a new concept and is being developed in a number of countries. In the United States, managers at medical laboratories, hospitals, and integrated health systems will want to stay informed about the ongoing efforts to use the hospital-in-the-home method as a way to improve patient care while lowering the overall cost of a healthcare encounter. One reason is that patients receiving care in their homes will need to be serviced by clinical laboratories.
David Levine, MD, Clinician-Investigator at Brigham and Women’s Hospital, told The Washington Post that despite initial reservations from staff, their testing of hospital-at-home care has been positive. “[Staff] very quickly realize that this is really what patients want and it’s really good care,” he stated.
Hospital-in-the-Home Costs Less, Better Care
Levine is lead author of a study published in the Journal of General Internal Medicine that compared the costs, quality, safety, and patient experience of 20 adult individuals admitted to emergency departments for an infection, exacerbation of heart failure, chronic obstructive pulmonary disease (COPD), or asthma.
“Median direct cost for the acute care plus 30-day post-discharge period for home patients was 67% (IQR, 77%; p < 0.01) lower,” the study authors note, “with trends toward less use of home-care services (22% vs. 55%; p = 0.08) and fewer readmissions (11% vs. 36%; p = 0.32). Patient experience was similar in both groups.”
Though authors acknowledged the need for a larger trial to create definitive results, they concluded that home-hospitalization resulted in reduced cost while allowing improved physical activity.
David M. Levine, MD (above right), Division of General Internal Medicine and Primary Care at Brigham and Women’s Hospital, describes the home hospital, a novel care model that brings hospital services to patients at home. Click on the image above to view the video. (Photo and caption copyright: Brigham and Woman’s Hospital.)
Hospitals caring for patients in their homes is not a new concept. In 2012, Dark Daily reported on a similar trial involving 323 patients across a year at Presbyterian Healthcare Services in Albuquerque, New Mexico. The study found patients of their hospital-based home care (HBHC) program achieved savings of 19% when compared to costs of similar hospital acute care patients.
Hospital-in-the-Home Care Impacts Pathology Groups and Medical Laboratories
One reason for the reduced costs should concern medical laboratories and other service providers—less diagnostic tests ordered. “During the care episode, home patients had fewer laboratory orders (median per admission: six vs. 19; p < 0.01) and less often received consultations (0% vs. 27%; p = 0.04),” noted the authors of the Brigham and Women’s Hospital study.
Another complication of HITH for clinical laboratories is the patient’s location. When tests are required, clinical laboratory personnel must collect samples in patients’ homes. This could prove a logistical challenge for both independent laboratories and hospital-based labs. Adding overhead for transportation and collection to an already shrinking volume of tests could negatively impact laboratory workflow and revenues alike.
Nevertheless, though HITH is still in its early stages, studies continue to show positive results. The biggest hurdle to adoption of HITH is convincing payers to cover it. Should providers find a way to convince payers to support the new approach, rapid growth of HITH programs is likely.
As more lab-on-a-chip, lab-on-a-fiber, and similar point-of-care diagnostic testing technologies mature and integrate with telehealth solutions and electronic health record (EHR) systems, they also could combine with HITH trends to further impact volumes and margins for clinical laboratories of all sizes.
Healthcare delivery is evolving, and clinical laboratories and pathology groups must remain flexible and support these advances. In adapting to changes and providing flexible services—such as remote collection in HITH care episodes—laboratories can reinforce their value in today’s modern healthcare market and work to compensate for changes in how diagnostic tests and lab results are both utilized and delivered.
