Diagnostics technology is experiencing a bit of an innovation revolution with advances and discoveries impacting the space seemingly more often today
than ever before. As research continues, more diseases and medical concerns are
being detected through relatively simple blood tests. Further, these
conditions are being recognized much earlier in patients, making
the fight against them a much more successful proposition.
With this in mind, for this issue’s Applying Tech, MDT took a
moment to speak with Dr. Bill Colston, the CEO of Health Tell
( www.healthtell.com), a company that is significantly enhancing
the effectiveness of diagnostics technology with a solution that
detects a wide array of diseases from a single drop of blood. He
shared insights into the diagnostics industry, current trends, and
what we can expect down the road.
Sean Fenske: How has diagnostics changed over the last
Dr. Bill Colston: The biggest change over the past five years
has been the advent of inexpensive, next generation sequencing.
These powerful new tools have driven massive efforts to discover
new genetic signatures for a variety of disease conditions and have the promise to
radically change some segments of medicine.
Fenske: How is point-of-care diagnostic technology impacting healthcare?
Dr. Colston: Point-of-care diagnostics have not really fulfilled their promise.
While a handful of new, molecular-based tests have begun to trickle outside the
central clinical laboratories, a number of factors have limited their development
and adoption. Major changes in the regulatory approval process, current clinical
practice, and payer behavior are needed to make this happen.
Fenske: How is diagnostics technology detecting disease in one drop of blood?
Dr. Colston: Detecting biomarkers in the blood is often like looking for a
needle in a haystack. Larger amounts of blood have typically been necessary
to collect enough of the biomarker to make a sensitive enough measurement.
Two new approaches are emerging to address this issue. The first, similar to
that described by Theranos ( www.theranos.com), uses microfluidics to more
efficiently make measurements using existing chemistries and techniques on
smaller volumes of blood. The second, pioneered by Health Tell, monitors the
body’s ability to amplify antibody-based biomarkers and monitor the immu-nological response to disease. This second approach has the benefit of creating
an entirely new class of diagnostic tests that are more accurate and sensitive, all
from a single drop of blood.
Fenske: What does this trend do for healthcare?
Dr. Colston: Currently, the bulk of blood-based diagnostics have to be made
through collection sites, and shipped in cooled containers to laboratories for anal-
ysis. The inconvenience of this process means a sizable fraction of patients never
have the tests completed. The expense and complexity of the collection, storage,
and shipping process add costs to the diagnostic tests and result
in slower time to results. Being able to collect a drop of blood
from virtually anywhere eliminates these issues, resulting in better
clinical outcomes and highly reduced cost.
Fenske: Do you expect to see a significant shift in more tests
being available as at-home solutions?
Dr. Colston: For the same reasons elaborated previously [sec-ond question on point-of-care diagnostics], I do not believe we
will see a significant uptake in at-home solutions for point-of-care
for molecular tests. There is a new wave of mobile or at-home
solutions for simpler, non-chemistry based diagnostic tests.
Fenske: What factors are playing a significant role in the development of diagnostic technology?
Dr. Colston: A number of key global trends are driving
the need for new diagnostics — a rapidly aging population correlated with
increased incidence of cancer and other chronic diseases; sky rocketing
healthcare expenditures; and a huge new wave of consumer involvement in
their personal wellness.
Fenske: What functionality is the medical industry requesting in the next
generation of diagnostic technology?
Dr. Colston: For serious chronic diseases like cancer, new tests are needed that
have dramatically better performance than existing screening or diagnostic tests.
In other areas, such as infectious disease, the need is to create easier, more cost-effective panels that provide real-time answers that drive therapeutic decisions.
Fenske: Where are we headed when it comes to diagnostic technology?
Dr. Colston: In five years, translation of current genetic discovery efforts onto
existing, molecular-based platforms, like real-time PCR, gene arrays, etc. Expansion of sequencing into the diagnostic space, as reads become longer and more
accurate. Early adoption of new, broad spectrum immune-based tests.
Ten years out, we’ll see a huge shift in the healthcare system that pushes
diagnostic tests to be ten times more cost effective with clear clinical utility. The
next generation of immune-based cancer therapeutics drives recognition that
diagnostics based on monitoring of the immune system play a critical role in
treatment and personalized medicine.
Further out, medicine shifts from managing sick people to keeping people
healthy. Waves of consumer- and employer-based awareness drives adoption of
at-home health monitoring for currently lethal chronic diseases, such as cancer.
Dr. Bill Colston,
CEO of Health Tell