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By Ronald McGlennen
10/09/07
Building Strategic Test Menus to Fit Your Lab and Business Model
The challenge for MDx labs is to create a test menu that promises larger sample
volumes and greater clinical utility versus offering a portfolio of esoteric
tests that add prestige and reduce their send-out costs. Choosing a test menu
also directs the selection of where the lab is housed, who runs the facility,
and what technologies will be hosted. This article presents an overview of
building strategic test menus, as well as two examples representing the experiences
of a private pathology lab and a community hospital.
Strategic Basics
According to Ronald McGlennen, MD, President & Medical
Director of Access Genetics (Eden Prairie, MN), the basic elements of building
a strategic test menu include the following:
1. Address
interest and need within your clinical community, as well as what clinicians
are requesting.
2. Determine
the IT and infrastructural support required to produce good results and manage
quality and quality assurance.
3. Testing
technology—which is an extraordinarily fast moving target.
4. Differentiate
between assays and tests. You need to focus not only on the technology to perform
gene chemistry, but also on what you will do to take a sample all the way to
its answer.
Next, he continues, the construction of a strategic menu involves
an overlay of elements that include the following:
• IT
capability, characterized—in part—by a Web portal.
• Development
of a laboratory infrastructure and marketing support for the growth of molecular
testing (characterized by a ring of expert technologists who know how to perform
these assays, troubleshoot them, and provide expert consultation).
• The
selection of technical platforms, which includes an increasing number of instruments
as well as assays. “The synthesis of these two concepts then becomes
kind of a ‘catalog’ of extraordinary opportunity, albeit one that
has to be sorted out intelligently,” McGlennen says.
“With the alignment of these respective wheels there is the construction
of the strategic test menu—that is to say, where the wheel hits the road,” he
notes.
Determining What’s on the Menu
“As you may already know, the vast majority of molecular diagnostic
testing still involves nucleic acid for testing infectious disease, representing
roughly 75 percent of the market,” McGlennen continues. “This really
hasn’t
changed much over the past decade or so. As a result, opportunities still principally
lie in testing for infectious markers. The question is, can we use these tests
as a basis to grow our laboratory business into more provocative and high-value
areas, including inherited genetic testing as well as testing for molecular
oncology. The contribution of paternity testing and other segments of this
market space are relatively unchanged with the exception, of course, of pharmacogenomics
(PGx), which remains an open-ended question.”
The chart at right illustrates
MDx testing by category in 2006.According to McGlennen, the next four years
will see a rise in the number of laboratories doing molecular tests and an
overall expansion of the pie. The chart at the bottom depicts some of the recent
areas of growth in the MDx arena by percent, pointing to genetic diseases as
the area of greatest growth.
However, he notes that genetic testing is still a relatively small wedge of
molecular diagnostics pie. In fact, overall there has been about a 19.4 percent
increase per year in test volumes of molecular diagnostics in those laboratories
already established in this arena. Most important, in looking for the tests
most likely to be the next great opportunities, he advises that one should
examine the list of most requested molecular tests sent-out that are also those
recommended by professional medical organizations. Endorsements by the various
medical organizations serve to accelerate the utilization of such tests and
are crucial in the development of a strategic test menu.
 The primary question
really is whether the distribution of testing opportunities will shift in any
significant way.
From a historical perspective, the most provocative test in
the molecular area was HIV and, subsequently, hepatitis C (HCV). Initially,
the tests started out with a yes-or-no result—present or absent. Then
the question became how much or how little. “Quantitative technology
began to be utilized and now we’re in the era of genotyping, which then
approaches how we compose intelligent therapeutic strategies,” McGlennen
explains. “Correspondingly,
without breaks in other types of infectious areas, we saw the rapid development
and deployment in testing for the West Nile Virus and Hepatitis B. After that,
the trajectory has been slower. For example, we’ve known about the human
papillomavirus (HPV) for 25 years, but only recently has it become a high-interest
area. This was driven by the adoption of this type of testing by the American
College of Obstetricians and Gynecologists (ACOG). In fact, clinicians have
driven the market growth in HPV testing. In addition, a similar story could
be written about cystic fibrosis (CF), where the ACOG has weighed in along
with other organizations to promote the use of this test in the MDx arena.”
What
this means is that the wheel actually drives the agenda by the set of clinical
questions being posed. “We need to listen carefully to what
clinicians are asking and then intelligently respond to their requests,” he
notes.
“Working with small laboratories, many naive to the molecular experience,
I have learned a lot about how to ‘turn over the rocks’ and find
where the opportunities lay,” McGlennen says. “It starts by asking
some very simple questions. However, keep in mind that clinicians often want
the latest test, especially those they read about in medical journals and other
publications. Moreover, while they may want these tests, they cannot provide
you with patient volume that is sufficient to support those assays. You have
to be responsive to that and help them by pointing out that you work with certain
kinds of materials.”
For McGlennen, “following the tissue” has
become somewhat of an axiom at his company. “If you own that tissue,
then you own the tests that are subsequently performed downstream from that
ownership. Current DNA extraction methods and gene chemistry permit high-quality
results from samples left over from blood, liquid Pap samples, the cells in
small volumes collected, and from fixed and paraffin embedded tissues—now
and particularly more so in the future.”
Clinical validation is another
key, McGlennen says, which translates into whether the tests offer answers
to questions that are supported by clinical studies and published literature. “This
is different from clinical utility, i.e., does the test contribute to the diagnosis
or management’s needs, and
will the doctor order them. In the end, if the tests are not utilitarian, doctors
won’t order them and you won’t be able to support them as part
of your strategic test menu.”
In addition, McGlennen says that you need
to investigate current in-house or send-out volumes. “Most hospitals
do not track the volumes on send-out esoteric tests,” he says. “They
view this as somewhat as an irritation and they pass them through. The greatest
volume of molecular tests often resides outside the hospital in outpatient
clinics, and so it would behoove you to go visit those clinics and determine,
for instance, what proportion of samples (patients) who are in maternity are
being test-requested for cystic fibrosis. You will also find that while the
hospital experience might result in a small number, the clinic experience will
be a much larger number. This is just a simple example of finding out where
those send-out volumes are actually being sent.”
McGlennen also suggests
that you investigate the methods needed to perform selected tests. “In
building a molecular laboratory, the fact is that there are many examples of
one-box, one-test solutions. However, this is not a strategic approach—in
fact, it is an expensive one. When putting together a strategic menu, you want
to find a little bit of a multiplex capability.”
About Information Systems
“We find that in laboratories that are bringing on molecular testing
they really do need organization because the surrounding technology is often
disparate and disconnected—piecemeal in their integration at best,” McGlennen
says. “In our case, we have tried to provide one version of an LIS (Laboratory
Information System) that helps clients understand the key operational processes
to provide quality assurance and quality control programs, as well as to be
able to produce aesthetic, informative, and clinically useful patient reports.”
Creating
Risk Assessment
Another role of molecular testing is as a means to create risk assessment. “As
laboratories embrace this new paradigm of answering more questions for clinicians,
they have to take on the responsibility of issues that have not yet occurred
for patients—including diseases that are not yet clinically manifest,” McGlennen
says. “We have tried to create a means of reporting molecular testing
that is useful in the assessment of disease risk. Inherent in that approach
comes the challenge of introducing physicians and patients alike to a new vocabulary,
i.e., the role of family history and how we communicate to patients. We do
so by creating reports.”
To illustrate, a CF report would include personalized and integrated Bayesian
calculation for the many cases of patients tested who are analytically negative,
but for whom the question regarding the potential for a baby to have CF remains. “Expanding
your IT presence becomes a central part of a strategic test menu,” he
notes.
In the area of “getting out into the community,” McGlennen
believes that electronic medical records are immensely useful. “The IT
systems go right into the clinician’s office in a paperless environment
where you can put test requisition slips that are inclusive of family history,
ethnicity, and other things important to the genetic test—as well electronic
reports.”
Distinguishing Between Assays and Tests
“By and large, we focus on elements of genetic testing, that center
on gene chemistry as well as the analysis. However, we must think inclusively
when we put together a strategic menu, including how we get that specimen,
how we perform DNA extraction, and how those results are compiled to form an
integrated report,” McGlennen says. “The distinction between assays
and tests then turns our attention back to what we already know, which is that
nucleic acid testing is very central to the garbage-in, garbage-out scenario.
We must have a good handle on how we do quantitative, qualitative, and high-quality
testing based on the procurement and management of nucleic acid testing. Before
you make major technology investments, make sure that you can do nucleic acid
testing well with your hands so that you will have a backup system in place.”
The
chart here provides a comprehensive overview of testing and assay
opportunities.
Case Study: Private Pathology Lab Creates a Woman’s Health
Panel
Dr. Mark Tulecke is the medical director of Seacoast Pathology (Exeter,
NH), a private lab that provides a full spectrum of testing for local hospitals,
as well gynecologic and non-gynecologic cytology and gynecological molecular
testing to both hospital-based and non-hospital-based physicians. Currently,
the lab conducts approximately 85,000 Pap smears annually. In June 2003, they
initiated a partnership with Access Genetics to add molecular testing.
“At that time, our menu focused predominately on women’s health-based
molecular tests that we could perform on the liquid-based Pap smear,” he
says. “We started with HPV testing and followed that shortly by the addition
of CT/NG.”
The lab’s marketing focus in bringing molecular testing
on board revolved around approaching clinicians about increasing the sensitivity
and specificity of its cervical screening program, which was done based and
on ACOG and ASCCP recommendations. “By bringing molecular testing in-house,
we were able to significantly decrease our turnaround times as well as offer
an integrated cytology report with the molecular testing or HPV testing findings.”
When the lab initiated HPV testing in June 2003, they were conducting approximately
150 tests per month. In the three years since, the lab has seen substantial
growth in volume and now conducts approximately 10,000 HPV tests per month.
Similarly, the lab started with about 130 chlamydia and gonorrhea (CT/NG) tests
a month, which has grown to roughly 600 tests per month.
“We believe that
the experience we’ve had demonstrates that a private
pathology laboratory can deliver cutting-edge molecular technology equivalent
to or better than some of the large reference laboratories,” he says. “By
performing molecular tests locally, we can deliver better service, increased
turnaround time, and integrated molecular reports.”
Looking ahead, Tulecke
plans to increase the lab’s volume primarily by
obtaining more Pap smears and implementing additional HPV and CTNG testing.
In addition, they are exploring the possibility of adding CF and thrombophilia
tests to the lab’s current menu on Pap smear specimens.
Case Study: Community Hospital Takes a One-Test-at-a-Time Approach
In the case
of hospital-based testing, there are some differences in the approach toward
the introduction of molecular diagnostics. “In a hospital testing,
the opportunity actually resides in the fact that there is access to a much
larger volume of samples and the potential of these volumes can be applied
to a number of high-value tests,” McGlennen says. “However, there
is no particular place to start obtaining these samples and focus on how a
test will be applied. Oftentimes, a hospital can’t pinpoint revenue so
that it can identify the opportunity that resides with doing these types of
tests.”
 The
chart details the differences (i.e., pros and cons) between establishing
MDx in a private lab versus a community hospital.
Cindy
Johnson MS, CLS (NCA), MT (ASCP), Director of Lab Operations for CentraCare
Laboratory Services (St. Cloud, MN), reports that her laboratory has ameliorated
many of these problems, specifically in bringing MDx testing into the laboratory
with a particular focus on inherited thrombophilia.
“Over the past few
years we have undergone a number of changes, one of them being the integration
of the hospital laboratory and several clinic laboratory sites into an independent
laboratory under the umbrella of our health system,” she
says. “We serve a large population, including two rural hospitals, as
well as multiple clinics—some having specialty clinics. I can’t
stress enough the importance of listening when setting up a molecular diagnostics
program. While physicians might not understand the mechanics of laboratory
testing, they do know they need the assistance of the test result in order
to make the diagnosis for their patients.”
While the MDx test menu started
out small and remains so, Johnson notes that growth will result as interest
has piqued. “We started out with Factor
V Leiden mutation and Prothrombin G20210A testing on a small scale, but we’re
seeing that our volumes are really increasing because we are able to offer
these tests within our laboratory,” she says. “While testing is
not performed daily, we do it a couple times throughout the week and our staff
is very excited about the addition of more complex testing in the laboratory.”
“The
concept of MDx testing was initially intimidating to some of the staff, Johnson
admits. “We have had an opportunity to develop this program
with our vendor partner and get the laboratory staff comfortable with performing
MDx testing. In addition, we will be bringing on HPV testing in the near future
as the clinical laboratory scientists in the laboratory want to expand our
molecular capabilities.”
Finding additional space to perform this testing
was a challenge for the laboratory. “Through
a process-improvement effort the laboratory has gone ‘lean’ and
this has resulted in freeing up more space in the back of the chemistry department,” Johnson
adds. “The MDx program has become a truly integrated venture as this
program is under the auspices of the microbiology department since they already
perform chlamydia and gonorrhea testing. The hematology department became involved
when the Factor V Leiden mutation and Prothrombin G20210A testing were added
to the MDx test menu. With the addition of HPV testing, there will be further
departmental collaboration with histology and cytology. The histotechnicans
process the liquid-based samples; the cytologists perform the Pap test; and
the clinical laboratory scientists will perform the HPV test. It has become
a team effort between the clinical laboratory, histology, and cytology departments—this
type of collaboration is a new concept for most hospital laboratories.”
Johnson
also notes that the hospital recently went “live” with
an electronic medical record (EMR) system. “Since HPV testing will be
performed in the clinical laboratory it is a challenge to integrate our Pap
test results, found in the pathology report, with the HPV test result,” she
says. “The goal is to have both the HPV test result and the Pap test
result available in the pathology section of the EMR. This will allow the provider
to easily correlate the two test results. However, integrating all the information
into one pathology report for physicians is still a work in progress.”
Finally,
Johnson adds that a physician technical advisory committee provides guidance
as to what additional laboratory testing to bring “in-house.” “As
our oncologists and a pediatric geneticist are expanding their clinical programs,
we have been asked to evaluate the need to bring on additional MDx testing.
When you get down to setting up a strategic test menu, it is all about listening
to the needs of the physicians, so that they can best serve our patients.”
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