MiOXSYS™ Male Infertility Oxidative System

EN
TE
R
Assay Procedure
Total hands-on time: < 1 minute
ALERT
TESTING
M
EN
U
Processing sample
2.00 min remaining
ENTER
MENU
iUnwrap
i
an individual
MiOXSYS Sensor and
place into MiOXSYS
Analyzer.
iUsing
i
a pipette, transfer
30µL of sample to the
Sample Application
Port of the inserted
MiOXSYS Sensor.
iOnce
i
detected, the
MiOXSYS Analyzer
will begin processing
the sample.
MiOXSYS is a quantitative electrochemical test for accurate and easy detection
of oxidative stress in fresh or frozen semen specimens.
Catalog Information
MiOXSYS System (100 sensors)................................. 100290
MiOXSYS Sensors (10 sensors).................................. 100283
MiOXSYS External Controls...................................... 100279
References
1. Khalil, Ashraf A. (2012): Oxidative stress induces idiopathic infertility in Egyptian Males.
Afr. J. Biotechnol. Vol. 11 pp. 1516-1522.
Introducing a simple approach to assess Oxidative Stress
2. Agarwal et al. Reproductive Biology and Endocrinology (2015)
3. Allied Market Research Report (2012)
MiOXSYS™ Male Infertility Oxidative System
4. Sigman M, Howards SS (1998). Male infertility. In: Walsh PC, Retik AB, Vaughan Jr ED, Wein AJ, editors.
Campbell’s Urology (7th ed.) Philadelphia:WB Saunders Company. pp.1287-1320
The most accurate, easy to use, and fastest oxidative
stress result available today.
373 Inverness Parkway
Suite 206
Englewood, CO 80112
©2015 Aytu BioScience
100301 REV 10/2015
The Effect
Having an accurate and fast oxidative stress test provides
actionable information for clinicians to improve patient
management and fertility outcomes. MiOXSYS provides efficient
use of your resources in identifying, differentiating, and treating
cases of male infertility attributed to oxidative stress.
Oxidative stress, a condition where
Augment Your Laboratory’s Semen Analysis Profile
the production of reactive oxygen species
overwhelms anti-oxidant levels, has been
considered as one of the major factors believed
to be involved in idiopathic male infertility1.
1. Deliver same day results to your clinicians
Need
Solution
Impact on Laboratory
Male Infertility Factor is the primary cause
of infertility in 20-70% of the cases2. It is
estimated that this condition affects
30 million globally2.
Identifying idiopathic cases of male infertility
requires an accurate, easy to use test that is
capable of measuring oxidative stress.
Luminometers
• Approximately $244MM in healthcare
costs associated with this condition3.
• 25% of the male infertility cases are
diagnosed as idiopathic and implicated
due to oxidative stress4.
• Current oxidative stress applications lack
a complete measure and system that is
easy to use in clinical practice.
–– Existing measures often look at
one aspect of oxidative stress,
requiring the use of multiple tests,
and a comprehensive analysis for
clinical interpretation.
–– Existing Systems lack standardization in
clinical practice because they employ
highly complex procedures, require
dedicated tech time, and entail capital
equipment costs.
MiOXSYS’s sORP measure is based upon the
principle of Oxidation-Reduction Potential,
which measures the giving and taking of
electrons. Unlike other measures, sORP
represents an integrated measure of oxidants
and reductants, making it a more clinically
meaningful measure.
• In clinical validation studies MiOXSYS’
sORP measure correlated with the known
factors of fertility,
–– Morphology: 96% Specificity 96% PPV
–– Motility: 86% Specificity 76% PPV
• The MiOXSYS System enables laboratory
efficiencies with stat capability, requiring
less than 1 minute hands on time, and
results in 3 minutes.
2. Immediately identify male infertility cases associated with high oxidative stress
3. Implement management and treatment strategies early on
Step Description
MiOXSYS System
Time
(minutes)
Step Description
Time
(minutes)
1
Immediately test sample
(cannot use frozen samples)
–
1
Test fresh or frozen sample
–
2
Centrifuge sample
10
2
Load sensor and
apply sample
–
3
Prepare sample in buffer
10
3
Test and results in 5 minutes
5
4
Inoculate 400µL of sample
into freshly prepared
luminol buffer
5
Test and results in
15 to 30 minutes
5 to 6
15 to 30
When every drop matters
Accurate: High Specificity and PPV with the known parameters of Fertility (Morphology 96%
Specificity and 96% PPV, Motility 86% Specificity and 76% PPV); Accurate detection for better
patient management and treatment goals related to Fertility.
Ease of use: Less than 1 min hands on time, ensuring the most efficient use of your staff time;
use of fresh or frozen samples
Fast: Results in as quick as 5 minutes, so you can deliver same day results to your clinicians