HomeTrak System for Monitoring Organ Transplant Maintenance
Therapy HomeTrak System for Monitoring Organ Transplant Maintenance
Therapy
Slide 2
HomeTrak System Outline of Presentation
Slide 3
HomeTrak System Therapeutic Drug Monitoring of
Immunosuppressants (TDM-IS) The Overall Process
Slide 4
Slide 5
HomeTrak System Equivalence to Venous Samples
Slide 6
Tacrolimus n=161 tests 1.8% mean absolute difference Rapamycin
n= 67 tests 2.9% mean absolute difference Cyclosporin n=70 tests
1.2% mean absolute difference NOTE: current ongoing data comparison
shows capillary vs. venous Everolimus correlation exceeds Sirolimus
correspondence Altman-Bland Analysis demonstrates Equivalence of
capillary to venous blood in testing
Slide 7
Example Comparisons in Consecutive Individual Patient Tests
LC-MS/MS analysis with Waters Acquity / Quattro Micro system TMS
BioScience in collaboration with Tulane Abdominal Transplant
Program 2007 IRB Study
Slide 8
HomeTrak System Advantages
Slide 9
Frequent monitoring of immunosuppressant drugs levels is
essential for proper transplant care HomeTrak Advantages At-home
sampling allows frequent monitoring - cases of noncompliance or
difficulty in achieving proper drug levels
Slide 10
Emerging Goals in Transplantation Reduce Side Effects of
Immunosuppressant Medication Therapy Preservation of Kidney
Function Decrease Risk of Cardiovascular Disease & Diabetes
Drug Levels must be CLOSELY monitored - Frequent and Flexible
Testing is absolutely necessary - TMS BioScience Labs HomeTrak
accomplishes this Critical Goal With recently improved short-term
outcomes, emerging long-term goals in organ transplantation include
minimization of CNI immunosuppressant (IS) drug toxicities, with
special emphasis on reducing nephrotoxicity and other direct
cardiovascular effects of currently used agents BY TRANSITIONING
THERAPY to mTOR INHIBITORS such as EVEROLIMUS.
Slide 11
Secondary Diseases are Major Causes of Death in Transplant
Patients Emerging Goals in Transplantation
Slide 12
HomeTrak System Use for Emerging Goals in Transplantation
Therapy HomeTrak facilitates frequent drug monitoring assists low
dose CNI treatment (minimization) Surveillance of patient
medication adherence Transition to mTOR therapy in chronic
allograft nephropathy from CNI treatment The addition of creatinine
& BUN renal profile assists team in monitoring kidney function
Liver enzymes can detect hepatic injury HomeTrak facilitates
frequent drug monitoring assists low dose CNI treatment
(minimization) Surveillance of patient medication adherence
Transition to mTOR therapy in chronic allograft nephropathy from
CNI treatment The addition of creatinine & BUN renal profile
assists team in monitoring kidney function Liver enzymes can detect
hepatic injury
Slide 13
HomeTrak System Special Utility of HomeTrak Tandem Mass
Spectrometry Instrument (MS/MS) Most Accurate Analytic Method-
lowest limit of detection Most Specific Method no metabolite
interference Alternative Sampling Strategy Allows analysis of small
blood sample volumes Small sample volumes allow at-home fingerstick
sampling Timely Results Reporting High through-put platform
hundreds of tests / 24 hours 2 minute / test produces rapid results
for clinicians
Slide 14
HomeTrak System Additional Tests to TDM-IS Serum is separated
by a proprietary process in TMS BioScience Labs Creatinine &
BUN renal profile and adjustment of medication dosage (clearance)
Liver Enzymes SGOT & SGPT liver injury Other serum tests can be
performed (custom) Serum Biomarkers (research) may be assayed Serum
is separated by a proprietary process in TMS BioScience Labs
Creatinine & BUN renal profile and adjustment of medication
dosage (clearance) Liver Enzymes SGOT & SGPT liver injury Other
serum tests can be performed (custom) Serum Biomarkers (research)
may be assayed
Slide 15
Venous vs. Capillary Samples Clinical Chemistry Creatinine
& BUN Normal volunteers NaEDTA collection simultaneous venous
& capillary Alfa-Wassermann - ACE Alera Clinical Chemistry
Analyzer TMS BioScience Labs - internal data on file --- Venous ---
Capillary Equivalence of HomeTrak Venous vs Capillary samples in
Renal Tests
Slide 16
Venous vs Capillary Samples for Renal Profile Tests Normal
volunteers NaEDTA collection simultaneous venous & capillary
Alfa-Wassermann - ACE Alera Clinical Chemistry Analyzer TMS
BioScience internal data on file
Slide 17
HomeTrak System Additional Tests CBC with differential
(complete blood count) done by desk-top flow cytometry provides
anemia analysis, white cell count & automatic differential, and
platelet count monitor blood system effects of immunosuppressants
BK viral load copy # in blood by qRT-PCR (AB 7500) to screen for
viral nephropathy (CMV, EB, JC, other screens in development) CBC
with differential (complete blood count) done by desk-top flow
cytometry provides anemia analysis, white cell count &
automatic differential, and platelet count monitor blood system
effects of immunosuppressants BK viral load copy # in blood by
qRT-PCR (AB 7500) to screen for viral nephropathy (CMV, EB, JC,
other screens in development)
Slide 18
At-Home Sample Collection a simple & straightforward
process > 98.6% success in patient performance in 80+ patients
evaluated
Slide 19
Micro Collection Tubes ~ 6 drops of Blood Patients provided
adequate volume sample without clots in 99.4% of 260 HomeTrak
samples sent in
Slide 20
Serum Separation for Clinical Chemistry microcentrifuge
technique with proprietary cell collection method Serum assayed for
Creatinine, BUN, SGOT, SGPT, ALP, others
Slide 21
HomeTrak Optional Test Menu Hgb A1C, cholesterol &
triglycerides HDL, LDL, and other clinical chemistries Other serum
enzymes: Alkaline Phophatase, etc. Therapeutic levels of numerous
drugs, antifungals, antivirals, neuroleptics, etc. Biomarkers and
DNA tests of interest Optional testing included in patent
application
Slide 22
HomeTrak System Patent Applied For Includes Additional tests
and Optional tests Patent assignment to inventor: Pleasant F.
Hooper, MD
Slide 23
HomeTrak Sample Stability Temperature exposure of whole blood
samples Immunosuppressants -stabile in blood 25 C for 7 days
confirmed in other published studies IS withstand 35 C for 48 hours
no loss of test accuracy this is also demonstrated in the
literature. Shipping of blood samples without cooling packs is
appropriate and functional proven in practice Serum based clinical
test stability for 48 hours at normal and elevated temps. -
HomeTrak results mirror clinic results Shipping of blood samples
without cooling packs is appropriate and functional proven in
HomeTrak history
Slide 24
HomeTrak Sample Stability at Temperatures 25-35 C for 48 Hours
Liver enzyme tests minimal loss at 24 hours 25 C - less accurate at
48 hours or elevated temps
Slide 25
HomeTrak Experience IRB - 33 patients (> 98% participation
of clinic and in hospital patients asked) 97% completed study-
95.7% of samples adequate improved over study 42 patients monitored
in demonstration project over 18 months included tacrolimus,
cyclosporin, and sirolimus therapy (prior to US approval of
everolimus) 97.4% completed the monitoring course many reports of
preference of fingerstick (patients with history of dialysis have
poor veins)
Slide 26
HomeTrak Experience Current HomeTrak utilization has increased
dramatically over last 6 months due to Zortress (everolimus)
prescribing for CNI transition and CRAD study of diabetes in
everolimus + low dose CNI (cyclosporin) protocol Currently no
widely available immunoassay for Zortress (everolimus) mass
spectrometry reference testing is the method in place Send out to
reference labs by patients discharged to home reveals problems with
results reporting
Slide 27
HomeTrak Experience Similar problem existed for Rapamune
(sirolimus) in 2008 mass spectrometry only available test method 7
day turn around time for send outs Very low utilization of Rapamune
at Tulane TMS BioScience began providing rapid results for Rapamune
testing Jan. 2008 June 2008 Rapamune utilization increased by 72.6%
over use in Jan. A six month increase driven by rapid results
reporting = practical dosing !!
Slide 28
HomeTrak Experience Currently monitoring 12 patients on
Zortress 5 are post-surgery dose titrations length of monitoring as
far as 4 months postop all patients have successfully performed
HomeTrak and are still being monitored by HomeTrak initial sampling
is bi-weekly, then weekly, then twice monthly. 7 patients have been
transitioned to Zortress after CNI therapy they are 1 to 2 years
post-transplant Patients homes are from 60 miles to 134 miles from
transplant center 2 state distribution
Slide 29
HomeTrak Experience HomeTrak is targeted service to transplant
programs the patients sample is sent directly to testing facility
(TMS lab) the samples are immediately tested due to priority in
work load (dedicated monitoring laboratory) results are reported
directly to transplant team by secure email and fax transmission
(nurses request) and are now being posted to a secure website for
review. Avoids the delay in having results entered into hospital
LIMS systems internal delays, lost reports
Slide 30
Website Results Reporting Smart phone and iPad accessible
Slide 31
HomeTrak Experience Potential Difficulties Potential Problem
solutions: Patient education to correct collection method, adequate
sample volume and proper time of collection (trough level critical)
this is a minimal incidence issue (< 3.6% of samples) and less
than 1% of patients experience problems. Video training DVD helps
and direct teaching during clinic visits Home Health visiting nurse
programs are under development to aid in patient teaching
Slide 32
HomeTrak Experience Potential Difficulties Problem areas:
Missed delivery or delayed delivery of samples this occurs
infrequently (< 2.6% of samples) and patient education and
carrier consultation are effective corrections Exposure of samples
to temperature extremes we have high temperature summer months and
potential for high temperature exposure using thermal strip
indicators in 10 samples sent during midsummer = no sample > 30C
encountered
Slide 33
Clinical Interest in HomeTrak Fingerstick monitoring has
attracted attention by clinicians We have received many inquires
and correspondence about HomeTrak
Slide 34
HomeTrak Summary HomeTrak is a novel method to monitor
transplant therapy initial dosing or transition to new therapy
Convenient, no extra patient cost, with high patient preference and
healthcare team acceptance & proven performance in use at
Tulane transplant Can be deployed anywhere in the nation Addresses
the problem of Zortress monitoring proven effective in Tulane
experience (Rapamune testing scenario from 2008) Central dedicated
laboratory with rapid reporting and internet access for healthcare
team.