Tina-quant Lp(a) RxDx Phase III Trial Sample Measurement

Tina-quant Lp(a) RxDx is an in vitro quantitative test for the determination of
lipoprotein (a) in human serum on cobas c systems. Tina-quant Lp(a) RxDx is
indicated as an aid in the identification of patients with atherosclerotic
cardiovascular disease and elevated lipoprotein (a) for treatment with the
pharma partner*s candidate drug.

The objective of this study is to support the pharma partner*s Phase III trial
using Tina-quant Lipoprotein (a) RxDx assay for subject selection and optional
batch testing of follow-up samples. This study is carried out to evaluate the
performance of Tina-quant Lipoprotein (a) RxDx assay in circumstances similar
to the routine conditions of use.
The data obtained from this study will be used in the performance evaluation
process and be part of the clinical evidence for the device. Data generated
under this study in combination with the clinical outcomes of Phase III trial,
if it reaches the safety and efficacy endpoint, will be used to validate the
assay clinically and thus for registration of the product with regulatory
authorities.

This diagnostic study includes the following experimental parts:
1. Study Familiarization
Within-run precision In this part of the study, the site personnel should get
acquainted with the system, reagents, and experimental design, WinCAEv and/or
WebCAEv. The appropriate function of the instrument and the reagent handling
are verified by performing a within-run precision experiment with controls
supplied by RDS. If the experiment performed in the Study Familiarization does
not meet the acceptance criteria, the root cause has to be found before the
other study parts can start. The data of the Study Familiarization experiments
are not used for evaluation of performance claims.
2. Initial Trial
LQ20
The Initial Trial has two parts. The first part of the Initial Trial is to
determine site-specific intermediate precision and bias in control recovery
(LQ20 experiment). Controls will be measured in 20 independent runs (the
procedure can be done in approx. 10 days (with a maximum of 2 runs per day) or
approx. 5 days (with a maximum of 4 runs per day). The intermediate precision
and bias will be used to define site-specific QC criteria. This experiment may
also be performed for a lot rollover or a new instrument setup over the course
of the study.
Correlation sample panel (CSP) The second part of the Initial Trial is to
assess laboratory bias using a correlation sample panel. Correlation sample
panel covers the measuring range of Tina-quant Lipoprotein (a) RxDx assay. A
method comparison analysis will be performed to compare the results of the
measurement to the target values established by RDS to determine the bias. The
site can only proceed to the Main Trial when the acceptance criteria are met.
3. Main Trial
Measurement of clinical samples During the Main Trial, clinical samples
collected from the Phase III trial will be measured. The RDS CRA will perform
data checks on validity of calibration and daily QC. Only after verification of
the validity of the Cal and QC measurements, the sample measurement data can be
released for transfer to the database defined by the pharma partner.
Measurement of follow-up samples (optional) The pharma partner may collect
clinical samples from enrolled participants after treatment with the
investigational drug. If requested by the pharma partner, RDS will support the
measurement of these follow-up samples. The same procedure will be followed as
outlined in the Main Trial.

The pharma partner's candidate drug will be compared to placebo. The placebo
will look like the pharma partner's candidate drug but it will not contain
active ingredients. A placebo has no medical effect but looks like the study
drug. Receiving placebo is the same as not taking any Lp(a) lowering
treatment. The pharma partner's candidate drug and placebo are both called
study drug in this form.
The pharma partner's is being developed as an experimental drug and is not
approved by any regulatory health agency (the Food and Drug Administration
[FDA], Therapeutic Goods of Australia [TGA], or European Medicines Agency
[EMA]).
The performance study IVD does not directly intervene with the subjects.

No direct risk associated with participating in the performance study to the
subject.