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 laboratories could offer services that complement SDH programs and help physicians find chronic disease patients who are undiagnosed
Insurance companies and healthcare providers increasingly consider social determinants of health (SDH) when devising strategies to improve the health of their customers and affect positive outcomes to medical encounters. Housing, transportation, access to food, and social support are quickly becoming part of the SDH approach to value-based care and population health.
For clinical laboratory managers and pathologists this rapidly-developing trend is worth watching. They can expect to see more providers and insurers in their communities begin to offer these types of services to individuals and patients who might stay healthier and out of the hospital as a result of SDH programs. Clinical laboratories should consider strategies that help them provide medical lab testing services that complement SDH programs.
Medical laboratories, for example, could participate by offering
free transportation to patient
service centers for homebound chronic disease patients who need regular
blood tests. Such community outreach also could help physicians identify people
with chronic diseases who might otherwise go undiagnosed.
Anthem Offers Social
Determinants of Health Package
In fact, health benefits giant Anthem, Inc. (NYSE:ANTM) partly attributes its 2019 first quarter 14% increase of Medicare Advantage members to a new “social determinants of health benefits package” comprised of healthy meals, transportation, adult day care, and homecare, according to Forbes.
“Our focus on caring for the whole person is designed to deliver
better care and outcomes, reduce costs, and ultimately accelerate growth,” Gail Boudreaux,
Anthem President and CEO, stated in a call to analysts, Forbes reports.
An Anthem news release states that SDH priorities for payers, providers, and other stakeholders should focus on enhancing individuals’ access to food, transportation, and social support.
In the Anthem news release, which announced the publication of a white paper that “outlines key differences in how individuals and the public perceive social determinants of health,” Jennifer Kowalski (above), Vice President of the Anthem Public Policy Institute stated, “By better understanding how individuals view and talk about social determinants, payers and providers alike can identify new and improved ways to engage with them to more effectively improve their health and wellbeing and the delivery of healthcare.” (Photo copyright: LinkedIn.)
CMS Expands Medicare
Advantage Plans to Include Social Determinants of Health
The Centers for Medicare and Medicaid Services announced that, effective in 2019, Medicare Advantage plans can offer members benefits that address social determinants of health. Medicare Advantage members may be covered for services such as adult day care, meal delivery, transportation, and home environmental services that relate to chronic illnesses.
Humana’s ‘Bold Goal’
Humana, Inc. (NYSE:HUM) calls its SDH focus the BoldGoal. The program aims to improve health in communities it serves by 20% by 2020.
“The social barriers and health challenges that our Medicare Advantage members and others face are deeply personal. This requires us to become their trusted advocate that can partner with them to understand, navigate, and address these barriers and challenges,” said William Shrank, MD, Humana’s Chief Medical Officer, in a news release.
UnitedHealthcare
Investing More than $400 Million in Housing
Meanwhile, since 2011, UnitedHealthcare (NYSE:UNH) also has invested in affordable housing and social determinants of health, Health Payer Intelligence reported.
In a news release, UnitedHealthcare, the nation’s largest health insurer, described how it is investing more than $400 million in 80 affordable US housing communities, including:
$12 million, PATH Metro Villas, Los Angeles;
$11.7 million, Capital Studios, Austin;
$14.5 million allocated to Minneapolis military
veterans housing;
$7.9 million, New Parkridge (in Ypsilanti, Mich.)
affordable housing complex;
$21 million earmarked to Phoenix low- and moderate-income
families needing housing and supportive services;
$7.8 million, Gouverneur Place Apartments, Bronx,
New York; and
$7.7 million, The Vinings, Clarksville, Tenn.
“Access to safe and affordable housing is one of the
greatest obstacles to better health, making it a social determinant that
affects people’s well-being and quality of life. UnitedHealthcare partners with
other socially minded organizations in helping make a positive impact in our
communities,” said Steve Nelson,
UnitedHealthcare’s CEO, in the news
release.
According to the American Hospital Association (AHA) and the Health Research and Educational Trust (HRET), housing, or lack of it, impacts health. In “Housing and the Role of Hospitals,” the second guide in the organizations’ “Social Determinants of Health Series,” AHA and HRET state that 1.48 million people are homeless each year, and that unstable living conditions are associated with less preventative care, as well as the propensity to acquire diabetes, cardiovascular disease, chronic obstructive pulmonary disorder, and other healthcare conditions.
Social determinants of health programs are gaining in
popularity. And as they become more robust, proactive clinical laboratory
leaders may find opportunities to work with insurers and healthcare providers
toward SDH goals to help healthcare consumers stay healthy, as well as reducing
unnecessary hospital admissions and healthcare costs.
Consumer demand and federal requirements for price transparency affect how clinical laboratories and anatomic pathology groups meet patients’ expectations while navigating complex payer agreements
Regardless of a clinical laboratory’s payer mix and revenue cycle management (RCM) system, the demand for greater price transparency impacts laboratory services just as it does other healthcare services. Addressing new federal policies that support price transparency may require medical laboratory managers to alter how they approach RCM and patient communications.
Patient access management (PAM) is what some early-adopter medical labs and pathology groups are using to respond to these new federal policies and changing patient expectations. PAM can be an effective tool to fulfill complex payer requirements and implement consumer-friendly healthcare services. Not only does this comply with federal guidelines, it helps independent laboratories increase revenue by lowering denial rates.
How
and When Clinical Laboratories Should Implement Patient Access Management
Revenue
cycle experts say clinical laboratories are in a position to take an active
role in the pricing transparency debate.
“If labs don’t control the pricing narrative, someone else will,” stated Walt Williams, Director of Revenue Cycle Optimization and Strategy for Quadax, a firm that has studied revenue trends in healthcare for more than 40 years, in an exclusive interview with Dark Daily.
He
says, given these new demands on clinical laboratories and pathology groups,
implementing patient access management practices ensures a satisfactory patient
and physician experience and reduces the financial risk related to trends in
uncollected revenue.
“In this
age of increasing consumerism—along with the complex challenges of navigating
the payer landscape and pre-empting administrative denials—it’s no wonder
independent labs are turning to new patient access technology solutions to
avoid leaving money on the table,” Williams said.
Patient
access management solutions allow clinical laboratories to:
obtain
accurate patient demographic information,
verify
insurance coverage and eligibility, and
gain
clarity on payer rules regarding prior authorization and medical necessity.
These
capabilities enable medical laboratories to secure appropriate reimbursement
closer to the date of service. PAM also can provide the ordering-physician with
financial counseling and guidelines on a patient’s financial obligation. This
would be shared with the patient to help prevent surprise billing.
New
Fact of Life for Labs: Patients Are the New Payers
Medical laboratory patient-access representatives must employ proper patient-liability collection techniques before, during, and after each date of service. This has become increasingly challenging as more patients join high-deductible health plans (HDHPs) and take on more financial responsibility. The problem for labs is that meeting the expectations of consumers requires a different toolset than meeting the needs of complex payer requirements.
Additionally, evolving policies in prior authorization, medical necessity, and coding (see, “Labs Get High Denial Rates Under New NCCI Rules,” The Dark Report) are resulting in potential payment traps for patients and known revenue traps for providers and suppliers.
The graphic above, taken from a KFF Health Tracking Poll conducted in 2018, lists “unexpected medical bills” as the top financial fear among Americans. “Four in 10 (39%) insured adults ages 18-64 say there has been a time in the past 12 months when they received care from a doctor, hospital, or lab that they thought was covered and their health plan either didn’t cover the bill at all or covered less than they expected,” the KFF poll notes. This illustrates the critical importance for clinical laboratories to implement patient access management protocols. (Graphic copyright: Kaiser Family Foundation.)
While
the current high cost of healthcare will likely continue for some time,
publishing information about the lab’s policies can help consumers view choices
when it comes to selecting laboratory tests and anticipating potential payment
obligations.
Henry Ford Health System, for example, posted information about prior authorization as it relates to its pathology and laboratory services.
Consumer-Facing
Price Transparency and CMS Requirements
Rooted
in price transparency regulations issued in July 2018, the federal Centers for
Medicare and Medicaid Services (CMS) encouraged “all providers and suppliers of
healthcare services to undertake efforts to engage in consumer-friendly
communication of their charges to help patients understand what their potential
financial liability might be for services they obtain, and to enable patients
to compare charges for similar services. We encourage providers and suppliers
to update this information at least annually, or more often as appropriate, to
reflect current charges.”
How
should we define “standard charges” in provider and supplier settings? Is the
best measure of a provider’s or supplier’s standard charges its chargemaster,
price list, or charge list?
What
types of information would be most beneficial to patients … enable patients to
use charge and cost information in their decision-making?
How
can information on out-of-pocket costs be provided to better support patient
choice and decision-making? What can be done to better inform patients of their
financial obligations?
What
changes would need to be made by providers and suppliers to provide patients
with information on what Medicare pays for a particular service performed by
that provider or supplier?
These
considerations and more can help the development of patient access management
and consumer-friendly communication initiatives that are tailored to clinical laboratory
services.
Patient
Access Management for Clinical Laboratories
Patient
access management facilitates critical components of the revenue cycle.
However, it must be fine-tuned to fit each healthcare provider’s unique revenue
cycle process. This includes clinical laboratory and anatomic pathology
services.
“Having
business rules and workflows based on best practices to verify patient
demographics, support insurance discovery, and navigate prior authorizations
are now a minimum requirement for any healthcare provider to maintain financial
viability,” Williams notes.
To help clinical laboratories fulfill CMS’ patient access guidelines—including best practices for reversing the trend of uncollected revenue—a free white paper titled, “Patient Access Antidote: Retaining More Revenue with Front-End Solutions,” has been published by Dark Daily in partnership with Quadax.
The
white paper will provide useful insights regarding front-end patient access
management. And it will equip clinical laboratories and pathology groups with
the expert tools and solutions they need to optimize their cash flow and
successfully meet key revenue cycle objectives.
Clinical laboratories may soon find opportunities to assist retail pharmacists who are doing genetic test counseling, as employers’ support of genetic testing advances
In another market example of acceptance of genetic tests by major employers, a new pilot program is underway by Kroger Prescription Plans that offers GeneSight by Myriad Genetics as a benefit. GeneSight is an LDT, a laboratory-developed pharmacogenomic test, used to treat psychiatric disorders, such as depression.
As part of the agreement with Myriad Genetics, Inc. (NASDAQ:MYGN), pharmacists at more than 2,300 Kroger stores will offer counseling about GeneSight to eligible employees and coordinate the testing with referring healthcare providers, according to a news release.
Clinical laboratory leaders and clinical pathologists will want to observe these early steps by Kroger to offer genetic tests and genetic test counseling in a retail pharmacy setting. If the GeneSight benefit option and in-store pharmacy interventions prove popular, Kroger Prescription Plans may soon offer other genetic tests, as well.
“Depression is a leading cause of disability and lost productivity in the United States, and only 40% of people reach remission after their first antidepressant medication,” Colleen Lindholz (above), President of Kroger Health, told the Cincinnati Business Courier. “We are committed to helping people combat this debilitating disease, and we’re proud to launch this pilot program. This test can help patients escape the frustrating process of trying multiple medications in the hopes of finding one that works.” (Photo copyright: EatingWell.)
Kroger Not the Only Pharmacy to Offer Genetic Tests and
Counseling
Headquartered in Cincinnati, Ohio, Kroger (NYSE:KR) is the largest supermarket chain in the US and the country’s fourth-largest employer. Kroger Prescription Plans—a pharmacy benefit manager (PBM)—provides pharmacy management services and clinical programs to employers, including Kroger, in 32 states. But it’s not the only pharmacy company to offer genetic tests and genetic counseling.
Last year Albertsons Companies and Genomind, a personalized medicine platform, launched Genecept Assay (now known as Professional PGx)—a genetic test designed to help doctors make informed treatment decisions for their mental health patients—as well as pharmacy-based genetic counseling at select Albertsons and its subsidiaries, according to Supermarket News.
Participating locations include:
21 Sav-On pharmacies at Albertsons in Boise,
Idaho;
Five Jewel-Osco pharmacies in the Chicago area;
and
Two Sav-On pharmacies at Acme supermarkets in
the Philadelphia area.
The Albertsons-Genomind partnership is aimed at patients who
may be struggling with a medication for depression, anxiety,
obsessive-compulsive disorder, or other mental illnesses. Patients can receive
counseling from “specially trained pharmacists” who work with referring
clinicians to offer [Professional PGx], noted Supermarket News.
Pharmacists as Genetic Test Counselors?
Pathologists and medical laboratory leaders may be intrigued
by the concept of putting pharmacists into the role of a genetic test
counselor. However, pharmacists may need to increase their knowledge of
pharmacogenomics, reported Drug
Topics.
“The science advances in the field are just making it more
critical that pharmacists have a really strong understanding of how to blend [pharmacogenomics]
into their training,” Kathleen Jaeger,
National Association of Chain Drug Stores
(NACDS) Senior Vice President of Pharmacy Care and Patient Advocacy, told Drug
Topics.
However, some see pharmacists as the natural experts in the space. “In my opinions, [pharmacists] should be the people who own pharmacogenetics. It’s a relatively new field, and who better than pharmacists to optimize drug therapy?” Daniel Dowd, PharmD, Vice President of Medical Affairs at Genomind, told Drug Topics.
Pharmacists will need to be proactive in working with companies that provide genetic testing, according to a Managed Health Care Connect Pharmacy Learning Network analysis, which also indicated billing for pharmacists’ informational services would need to be addressed.
“These opinions about this type of role for pharmacists will not be what pathologists want to hear,” stated Robert L. Michel, Editor-In-Chief of The Dark Report, Dark Daily’s sister publication. “Pathologists have had the role of the ‘doctor’s doctor’ for decades. Pathologists are trained in how to recognize disease, how to determine which medical laboratory tests are appropriate for the symptoms displayed by a patient, and how to interpret the results to select the best therapies.
“Additionally, pathologists are trained to understand the
technical performance of clinical laboratory tests, such as whether the sample
was of acceptable quality to produce a reliable result, whether the analyzer
that produced a result was performing within specifications, and what factors
should be considered in tandem with the lab test results when making a
diagnosis,” he explained. “It is easy to see why the pathology profession would
argue that pharmacists lack this depth of knowledge and experience when
ordering and interpreting medical laboratory tests. How the pathology
profession will respond to these developments involving pharmacists,
interpretation of genetic test results, and counseling patients is not yet
clear.”
Opportunities for Clinical Laboratories to Assist
Pharmacies
Additionally, we suggested, clinical laboratory leaders and
pathologists could find opportunities helping others understand the results of
the genetic tests.
The recent partnerships between genetic test companies and
corporate retail pharmacies suggest that clinical laboratories could benefit
from reaching out to pharmacists who are now at a point-of-care and who may be
looking to improve their knowledge of pharmacogenomics.
Clinical pathologists may not see new diagnostics based on the technology anytime soon, but synthetic DNA could be immune to virus infections
Can DNA of bacteria be manipulated to create new bacteria that can be used to manufacture useful things? Should scientists be creating life from lifelessness? Researchers at University of Cambridge in the UK think so. They have synthesized the entire DNA of E. coli and produced a synthetic life-form that reproduces and behaves very similarly to its naturally-occurring counterpart.
This clearly is a leap forward in the study of synthetic biology. But will clinical laboratories see new diagnostics from the technology? Clinical pathology professionals, microbiologists, and infectious disease specialists are extremely familiar with E. coli. However, in the realm of pathology, it’s common for such research to result in more precise methods of diagnosing disease.
Nevertheless, the New York Times (NYT) noted several potential uses for this technology:
“Viruses may not be able to invade recoded cells. Many
companies today use genetically-engineered microbes to make medicines like
insulin or useful chemicals like detergent enzymes. If a viral outbreak hits
the fermentation tanks, the results can be catastrophic. A microbe with
synthetic DNA might be made immune to such attacks.”
Jason W. Chin, PhD, a professor of chemistry and chemical biology at the University of Cambridge in the UK, led the research team. He told the Cambridge Independent the researchers chose E. coli because, “in addition to the strain that leads to a hideous bout of diarrhea and vomiting, E. coli is very useful as a biological model.
“Experiments on hardy, non-pathogenic strains have helped us
advance our understanding of biology, and it is used in therapeutics, including
to create insulin to treat diabetes, and to treat hemophilia, gout, cancer, and
other diseases,” Chin notes.
“E. coli is a real workhouse in biology,” he continued. “So,
this is a practical choice both for studying basic biology and for
biotechnology.”
The researchers published their findings in the international science journal Nature.
In their paper, the researchers describe how they recreated
a genome that was approximately four-million segments long, and then replaced
the bacteria’s original genome with a “recoded genome”—piece by piece.
“It’s a landmark,” Tom Ellis PhD, Director of the Imperial College Center for Synthetic Biology in London, told the NYT. “No one’s done anything like it in terms of size or in terms of number of changes before.” Ellis was not involved in the study.
Genetic code, for any living being, is filled with
redundancies that have baffled researchers. Chin, like many others, wondered
why. “Because life universally uses 64 codons, we really didn’t have an
answer,” Chin told the NYT.
Every gene is made up of combinations of pairs of the four main nucleobases found in the nucleic acid of DNA and RNA. They are:
A single gene can be composed of thousands of these bases. A set of three bases is called a codon.
The synthetic DNA Chin and his team built reduced the number of codons where they could. A Chemistry World article notes, “Using DNA synthesis, [Chin and his team] have rebuilt the entire 4-million-base pair genome of Escherichia coli in which two of the six codons for serine and one stop codon were replaced with synonyms, giving the genome just 61 codons rather than 64. They introduced this synthetic genome, with about 18,000 instances of altered codons, into E. coli cells to create a new strain that they call Syn61.”
Chin plans to further compress the genetic code in future
experiments to learn how streamlined it can be and still support life.
Prior to this study, the longest synthetic DNA recorded was
about one million segments, so this was a significantly longer strand. When it
came time to place it in the bacteria, they had to do it one segment at a time,
until the natural genome had been completely replaced.
Initially, there was doubt that the Syn61 organism (shown above growing on an agar plate) would continue to live with the synthetic genome, but it did. It is shaped differently than E. Coli with natural DNA, and it reproduces more slowly. Whether Chin Labs’ discovery will result in new clinical pathology diagnostics remains to be seen. (Photo copyright: Wesley E. Robertson/Stat.)
Expanding the Genetic Alphabet
In addition to this study marking several important
“firsts,” this study also has numerous implications for potential future
research. As noted above, eventually scientists may be able to recode microbes
making them immune to viruses.
Another interesting idea is that synthetic, recoded DNA may mean that researchers could program cells in such a way that their genes won’t work if they escape. “It creates a genetic firewall,” Finn Stirling, a graduate student at Harvard University in the UK, told the NYT.
“The space that codon compression ‘frees up’ in Syn61 might
be used to code for non-natural amino acids, giving these organisms a different
biochemical basis to natural ones,” the Chemistry World article notes.
In other words, the extra space created by removing redundant codons could be
used to create drugs, proteins, and enzymes.
“It’s pretty mind blowing that you can expand the genetic alphabet this way. I think we’re pretty far from realizing how much we can do with it, producing things we have never seen before,” Julius Fredens, PhD, a member of the Cambridge research team, told BBC News.
The primary goal of the Cambridge researchers was to learn
how to manipulate the DNA of bacteria for the purpose of using those bacteria
to manufacture useful things. That’s a different emphasis than using this technology
for therapy or diagnosis. But significant new tools for clinical pathology
diagnostics have come from lesser discoveries. So, this is research worth following.
