혈청 시료를 이용하여 종양의 증식능력을 고감도로 측정하는 DiviTum™ V2 kit
• Will the treatment work or not ?
• Is the treatment working or not ?
Those are key questions where DiviTumTM have the possibility to make a significant contribution of major
value to clinicians and pharmaceutical research companies.
혈청 중의 TK (Thymidine Kinase) 활성을 방사성 동위원소를 사용하지 않고 비색법에 의해 매우 고감도로 측정 할
수 있는 kit 입니다. 세포분열 활동의 지표인 TK 활성을 측정함으로써 종양 증식 능력을 분석 할 수 있습니다. 혈액암
(백혈병, 골수종) 뿐만 아니라 고형암 (유방암, 전립선암, 폐암, 신장암) 등과 관련한 혈청 TK의 활성을 측정 할 수
있습니다. TK 활성을 측정함으로써 종양의 사전 예방 및 조기 치료와 치료의 효율성을 관찰하는 도구로써 사용 될
기존의 DiviTumTM kit는 분석결과가 나오기 까지 약 2 일이 걸렸지만, 새로 개발된 DiviTumTM V2 kit는 과정이 간편
화 되어 작업 시간이 8시간 내로 단축 되었습니다.
DiviTum™ – Cell Proliferation Determination from a Simple Blood Test
DiviTum™ measures thymidine kinase (TK) activity in a serum sample, and the activity is proportional to the
amount of dividing cells in contact with the blood stream in the whole body. Since the most prominent feature
of cancer is uncontrolled cell division, DiviTum™ allows for determination of cell proliferation and tumor
DiviTum™ – the new generation TK test
The method of measuring TK activity with a radioactive technique has been used for more than 30 years
within hematological cancer diseases, mainly of the monitoring of lymphoma and leukemia. The same
measurements can now be performed with DiviTumTM, without using radioactivity. And the test’s increased
sensitivity allows the detection of at least ten times smaller growth activity, which greatly widens the
applicabilityto solid tumors.
DiviTum™ – additional tool to assist in monitoring of cancer
By regularly following a person’s TK value over time, tumor growth can be monitored, detected early and the
chance for a better prognosis increases. DiviTum™ also facilitates personalized medication, since it can
predict treatment efficacy. In short DiviTum™ can be used as a tool for,
• Prediction of response to chemotherapy in metastatic breast cancer
• Prediction of risk of recurrence, progression free- and overall survival
• Monitoring of disease progression and therapy effect
The DiviTum™ technology
DiviTum™ measures cell proliferation rate by analyzing thymidine kinase (TK) activity in a serum sample.
The TK activity reflects the tumor growth activity in the body. Since the most prominent feature of cancer is
uncontrolled cell proliferation, this allows for determination of tumor aggressiveness.
The role of thymidine kinase in DNA-replication
Thymidine kinase has a key role in the synthesis of DNA and thereby in cell division & proliferation. By
phosphorylating thymidine, thymidine kinase performs one of the steps for its incorporation into DNA, where it
serves as one of the four building blocks of the genetic code.
In a healthy individual, the Thymidine Kinase activity measured in blood is low. When something happens
that increase cell proliferation in the body, it is reflected in increasing serum TK activity. TK is the only bio-
marker for cell proliferation that can be measured directly in a blood sample and DiviTum™, Biovica’s
patented, CE-labelled assay is the most sensitive technique for measuring TK-activity in serum.
Thymidine kinase and cancer
Tumors are characterized by uncontrolled cell growth and are known to express higher levels of TK activity
than normal tissue. The rate of cell growth, as well as increased levels of TK activity, has been found to be
directly linked to the aggressiveness of a tumor. Since the first commercial test for TK-activity was
introduced in the 1980’ies, thousands of studies have reported on the close relation between serumTK levels,
tumor aggressiveness and patient outcome. This is in contrast to TK assays that are not activity-based.
Such assays are either not truly quantitative or have not been well documented.
DiviTum™, Biovica’s patented, CE-labelled and highly sensitive assay for measuring TK-activity in serum,
has been shown to be clinically valuable for prognosis, prediction of therapy efficacy, monitoring and follow
up of cancer patients. DiviTum™ is the most sensitive test available for measuring serum TK-activity and
has also the highest resolution of TK-activity determination.
Compared to biopsies, using a blood sample saves time, is cost efficient and considerably more convenient
for the patient than a biopsy or imaging based tests.
TK activity reflects the aggressiveness of a tumor. It can be measured in a simple blood sample that save
time, reduce cost and is more convenient for the patient than using biopsies/tumor tissue or imaging
techniques. DiviTum™ can be used to for accurate prognosis, predicting therapy efficacy & patient outcome
and monitoring of cancer. DiviTum™ is the most sensitive assay available for measuring TK activityin
The Assay Principle of DiviTum TK-activity determination
The DiviTum test determines the enzymatic activity of TK in the patient samples.
TK catalyses the reaction:
Thymidine + ATP → Thymidinemonophospate + ADP
In the DiviTum test, thymidine is replaced by another molecule, bromodeoxyuridine (BrdU), which is
accepted by TK as an analogous substrate:
BrdU + ATP → BrdU-monophosphate + ADP
When the serum sample is mixed with the reaction mixture in the well of the microtitre plate provided, the
serum TK makes BrdU-monophosphate, which by other enzymes is further phosphorylated to BrdU-
triphosphate and incorporated into a DNA-strand bound to the bottom of the well. The amount of BrdU built
into the DNA-strand is determined by the TK-activity in the serum sample.
The BrdU incorporation is detected by ELISA-technique using an anti-BrdU antibody conjugated to alkaline
phosphatase and a chromogenic substrate. The optical density of the color produced by the alkaline
phosphatase is proportional to the activity of TK in the patient serum. The conversion of the absorbance
readings to DiviTum-units per litre (Du/L) is calculated using the values from standards with known TK-
(분석 및 측정의 간단한 예)
The TK activity is given as Du/L. 1000 Du/L corresponds to the activity in a solution containing 1000 ng/L of a
reference sample of recombinant TK. The TK activity in serum spans <10 Du/L – >100 000 Du/L. The
DiviTum™ V2-test has an analytical sensitivity of 20 Du/L (LLQ. The working range extends up to 4000 Du/L
or to the reader’s asserted upper limit of detection if this corresponds to a TKactivity lower than 4000 Du/L.
The precision (CV) at 100 Du/L is better than 20%. The assay defines apparent TK activity on the basis of the
amount of DNA produced and quantified using an ELISA technique. The TK activity is not strictly proportional
to the TK concentration present and thus the assay should always be performed using the amount of serum
and incubation times given in this the Instruction for Use.
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Instruction sheet (PDF)
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