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Biomarkers: Q & A
Biomarkers are proteins or other cellular components that relate
specifically to injury or to disease and that can be found in body
fluids such as CSF, blood or urine. The presence and quantity of the
biomarker in these fluids can be determined by antibody-based assays to
assess the degree of injury or disease and in the best circumstances to
determine recovery. To be specific for injury or disease, the presence
of the biomarkers in body fluids must depend on the diseased state and
they should not be present in these fluids under normal conditions.
Important for the use of the biomarker is the development of specific assays that can
detect the biomarker over a large dynamic range, roughly in the range from fg/ml to ug/ml in the fluid, and  the
detection system should be free of interferences from the body fluids
themselves. Antibody based assays have been developed by Banyan
scientists that meet this criteria for some of the 42 potential
biomarkers that Banyan has discovered. Currently, the assays are being
improved and validated
for their specificity and sensitivity.
Development
of valid biomarkers of TBI will have a major impact on diagnosis,
management and treatment of brain injury patients. Accurate diagnosis
in acute care environments can significantly simplify decisions about
patient management including whether to admit, discharge or to
administer other time consuming, expensive and often inaccurate
diagnostic tests including computed tomography (CT) and magnetic
resonance imaging (MRI) scans. Similarly, triage is a major function of
far-forward medical care in combat environments or during national
disasters. Simple, rapid diagnostic tools will immensely facilitate
allocation of the major medical resources required to treat TBI and
other brain injuries in combat or following a national disaster.
 Biomarkers
could have important prognostic functions especially for patients
suffering from mild TBI which make up an estimated 80% of individuals
who suffer from life-long impairment as a result of TBI. Accurate
identification of these patients will facilitate development of
guidelines for return to work or sports activities and also provide
opportunities for counseling of these patients suffering from these
deficits.
The development of biomarkers will play an important role in discovery of therapies
to treat TBI.
In
addition, these markers will be extremely useful in the conduct of
clinical trials to assess the efficacy of potential therapies to treat
brain injury.
- Why is Banyan Biomarkers, Inc. uniquely qualified to develop diagnostics for brain
injury?
Banyan
Biomarkers, Inc. was founded by individuals with a unique combination
of skills that has made possible rapid development of novel and
powerful biochemical markers of TBI. Banyan’s research and development
strategy involves early integration of insights into cell pathobiology
and clinical utility closely linked to discovery platforms employing
cutting edge biochemical technologies including high-throughput
proteomic capabilities. Banyan is also able to rapidly screen potential
biomarkers using laboratory studies in animals for preclinical
assessments and proprietary technology to expedite early clinical
validation in
human TBI patients.
Unlike other diagnostic
companies, Banyan Biomarkers, Inc. is focusing on diagnostics for
trauma. Banyan has developed novel biomarkers that can provide
important information on the severity of injury, the location of the
injury in the brain and the biochemical mechanisms underlying this
injury.
- Can Banyan Biomarkers Inc. apply this technology to other types of injuries?
Traumatic
injury to any organ in the body results in remarkably similar
destructive biochemical cascades. The development of biochemical
markers for injury to the brain will lay the foundation for rapid
development of biochemical markers to other injured organs such as the
heart, liver and lungs. Development of biochemical markers to other
organs is an important clinical goal and market opportunity. Traumatic
injury to a single organ rarely occurs in isolation, and multi-organ
trauma is a major clinical problem. In fact, Banyan Biomarkers is
currently developing a novel marker of cardiac injury.
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