Exacta Test

Keemiaravi juhtimine

Chemosensitivity testing is a method where actual drug efficacy is tested before the start of the therapy.

Chemosensitivity testing makes it possible to assess the sensitivity of tumor cells to various chemotherapeutic agents before treatment begins.

Despite the rapid development of targeted therapies and immunotherapy, chemotherapy remains one of the cornerstones of cancer treatment and is often used as part of combination treatment regimens.

    EST Keemiaravi tundlikkuse testimine (chemosensitivity testing) võimaldab hinnata kasvajarakkude tundlikkust erinevate kemoterapeutikumide suhtes juba enne ravi alustamist.
Hoolimata sihtmärkravi ja immunoteraapia kiirest arengust on keemiaravi endiselt üks vähiravi alustalasid ning sageli kasutatakse seda kombineeritud raviskeemide osana.

In clinical practice, the effectiveness of chemotherapy is usually assessed only after several treatment cycles, for example, by evaluating changes in tumor volume on CT scans. Genetic profiling alone does not always allow treatment response to be predicted. Even genetically similar tumors may respond very differently to drugs, as their behavior is influenced not only by genetic alterations but also by RNA activity, epigenetic mechanisms, and the tumor microenvironment.

EST Kliinilises praktikas hinnatakse keemiaravi efektiivsust enamasti alles pärast mitut ravitsüklit, näiteks kasvaja mahu muutuse alusel kompuuteruuringutel. Ainuüksi geneetiline profiil ei võimalda alati ennustada ravivastust. Ka geneetiliselt sarnased kasvajad võivad reageerida ravimitele väga erinevalt, kuna nende käitumist mõjutavad lisaks geenimuutustele ka RNA aktiivsus, epigeneetilised mehhanismid ja kasvajat ümbritsev mikrokeskkond.

A medical professional studies CT scans on multiple monitors in a dimly lit medical office.
 

The Exacta study uses a functional precision oncology approach, in which the actual response of circulating tumor cells to different chemotherapy drugs is assessed under laboratory conditions. This makes it possible to predict the effectiveness of the drugs before they are administered to the patient.

The method is supported by clinical studies involving more than 5,000 patients. When circulating tumor cells were compared with tumor tissue obtained from the same patient, the concordance of the functional chemotherapy test was 93.7%.

Depending on the number of circulating tumor cells isolated from the patient’s blood, the effects of approximately 30–60 chemotherapy drugs are evaluated.

 EST Exacta uuringus kasutatakse funktsionaalset täppisonkoloogia lähenemist, mille käigus hinnatakse laboritingimustes tsirkuleerivate kasvajarakkude tegelikku reaktsiooni erinevatele keemiaravimitele. See võimaldab prognoosida ravimite tõhusust enne nende manustamist patsiendile.

Meetodit toetavad kliinilised uuringud enam kui 5000 patsiendil. Tsirkuleerivate kasvajarakkude ja samalt patsiendilt pärineva kasvajakoe võrdlemisel on funktsionaalse keemiaravitesti kooskõla olnud 93,7%.

Sõltuvalt patsiendi verest eraldatud tsirkuleerivate kasvajarakkude arvust hinnatakse ~30–60 keemiaravimi toimet.

Meetodi eelised

Empirical data - chemo-scale in its methodology and has extensive clinical evidence.
Results in percentages - chemo-scale reveals cytotoxic chemotherapy drug efficacy
Ranking of test results - The medical findings list the recommended medications in order of effectiveness
Broad range of substances - Analysis is carried out for single drugs in a fixed panel and - on request - for complementary drugs.

Immunocytochemistry ICC

Datar Cancer Genetics has developed a novel method to perform immunocytochemistry on circulating tumor cells. Circulating tumor cells will be characterized with antibodies and become a real-time assessement of the tumor in the present moment. The cells when characterized can track the loss of therapeutic targets, detect eraly resistance mechanisms and ajdust therpy earlier than than tissue biopsy or imaging.
 

Cell characterization makes it possible to:

  • monitor the loss of therapeutic targets;
  • identify early mechanisms of treatment resistance;
  • adjust treatment earlier than would be possible based on tissue biopsy or radiological imaging.

EST Rakkude iseloomustamine võimaldab:

  • jälgida ravisihtmärkide kadumist;
  • tuvastada varajasi raviresistentsuse mehhanisme;
  • kohandada ravi varem kui seda võimaldavad koebiopsia või radioloogilised uuringud.
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Pharmacogenetics

Pharmacogenetics studies how an individual’s genetic background affects drug metabolism and helps predict individual differences in drug metabolism, treatment response, and the risk of adverse effects.

EST Farmakogeneetika uurib, kuidas inimese geneetiline taust mõjutab ravimite ainevahetust ning võimaldab prognoosida individuaalseid erinevusi ravimite metabolismis, ravivastuses ja kõrvaltoimete riskis.

Cytochrome P450 (CYP450) enzymes are particularly important, as they are involved in the metabolism of a large proportion of clinically used drugs. They influence:

  • how quickly a drug is activated in the body;
  • how quickly it is broken down;
  • how long the drug remains in the body;
  • whether toxic metabolites may accumulate.

 

EST Eriti olulised on tsütokroom P450 (CYP450) ensüümid, mis osalevad suure osa kliinilises kasutuses olevate ravimite metabolismis. Need mõjutavad:

  • kui kiiresti ravim organismis aktiveerub;
  • kui kiiresti see lagundatakse;
  • kui kaua ravim organismis püsib;
  • kas võivad kuhjuda toksilised ainevahetusproduktid.

The Exacta report summarizes which medications are best suited to the patient’s genetic profile and which medications may carry an increased risk of toxicity or serious adverse effects. This helps the treating physician select a more appropriate treatment regimen before treatment begins.

EST Exacta aruanne koondab, millised ravimid sobivad patsiendi geneetilise profiiliga kõige paremini ning milliste ravimite puhul võib olla suurenenud toksilisuse või tõsiste kõrvaltoimete risk. See aitab raviarstil valida patsiendile sobivama raviskeemi juba enne ravi alustamist.

Exacta includes

  • CYP450 gene genotyping
  • analysis of drug transporter proteins
  • genetic assessment of drug efficacy and toxicity

Whole Transcriptome RNA sequencing

Human body has ~20 000 protein coding genes and RNA sequencing can assess which of the human genes are actively expressed and to what extent in a given cell or tissue at a specific time. This is very relevant part of the Exacta study, since it helps to understand tumor biology holistically.

EST Inimese genoom sisaldab ligikaudu 20 000 valku kodeerivat geeni. RNA sekveneerimine võimaldab määrata, millised neist geenidest on konkreetses rakus või koes antud ajahetkel aktiivsed ning millisel määral need avalduvad.

See on üks Exacta uuringu olulisemaid osi,
kuna aitab mõista kasvaja bioloogiat terviklikult, mitte ainult geneetiliste
mutatsioonide tasandil.

 

The report includes a patient-specific signaling pathway activity profile based on KEGG signaling pathway analysis. This helps identify:

  • disrupted intracellular signaling pathways;
  • potential biological dependencies of the tumor;
  • mechanisms of drug resistance.

EST Aruanne sisaldab patsiendipõhist signaalradade aktiivsuse profiili, mis põhineb KEGG signaalradade analüüsil. Selle abil tuvastatakse:

  • häirunud rakusisesed signaalirajad;
  • kasvaja võimalikud bioloogilised sõltuvused;
  • ravimresistentsuse mehhanismid.
 

This information helps identify tumor vulnerabilities by linking active signaling pathways to drugs that may inhibit their activity. This supports more informed treatment decisions and may help improve treatment outcomes.

EST Need teadmised aitavad leida kasvaja nõrkusi, sidudes aktiivsed signaalirajad ravimitega, mis võivad nende aktiivsust pärssida. See toetab teadlikumaid raviotsuseid ning võib sealjuures parandada ravitulemusi.

Exacta includes

  • analysis of RNA expression across the entire human transcriptome, comprising approximately 20,000 genes.
    RNA can be extracted both from tumor tissue preserved in paraffin blocks and from exosomes found in the patient’s blood.

Tumors release higher-than-normal levels of exosomes into the bloodstream, which carry genetic material characteristic of the tumor. The method has been clinically validated and is particularly valuable in situations where treatment has been unsuccessful and the tumor’s behavior needs to be reassessed in order to adjust therapy.

EST Kasvajad vabastavad vereringesse tavalisest rohkem eksosoome, mis kannavad endas kasvajale iseloomulikku geneetilist materjali. Meetod on kliiniliselt valideeritud ning eriti väärtuslik olukordades, kus ravi ei ole olnud edukas ja kasvaja käitumist tuleb ravi kohandamiseks uuesti hinnata.

DNA sequencing

The aim of DNA sequencing is to identify actionable genetic alterations in order to find targeted therapy options. Targeted therapies block abnormal molecular targets in cancer cells while minimizing damage to healthy tissues.

Examples: Lung cancer – EGFR mutations, ALK rearrangements, ROS1 fusions. Breast cancer – BRCA mutations. Melanoma –. Colorectal cancer –. Ovarian cancer – PARP inhibitors associated with BRCA mutations.
Targeted therapy is also used for thyroid, prostate, gastric, and certain brain tumors.

EST DNA sekveneerimise eesmärk on tuvastada ravitavaid geneetilisi muutusi, et leida sihtmärkravi võimalusi. Sihtmärkravimid blokeerivad vähirakkude ebanormaalseid molekulaarseid sihtmärke, kahjustades võimalikult vähe terveid kudesid.

Näiteid: Kopsuvähk – EGFR mutatsioonid, ALK ümberkorraldused, ROS1 fusioonid. Rinnavähk – BRCA mutatsioonid. Melanoom –.Jämesoolevähk . Munasarjavähk – BRCA mutatsioonidega seotud PARP inhibiitorid.
Sihtmärkravi kasutatakse ka kilpnäärme-, eesnäärme-, mao- ning mõnede ajukasvajate korral.

 

DNA sequencing also makes it possible to determine important biomarkers that help assess the potential effectiveness of immunotherapy.

 

EST DNA sekveneerimine võimaldab lisaks määrata olulisi biomarkereid mis aitavad hinnata immunoteraapia võimalikku efektiivsust.

  • TMB (Tumor Mutational Burden);
  • MSI (Microsatellite Instability);
  • HRD/HR biomarkers,
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TMB

TMB indicates the total number of mutations present in the tumor DNA and is typically expressed as mutations per megabase (mut/Mb).

A high TMB means that the tumor contains a large number of mutations, resulting in the production of more abnormal proteins. These can make the tumor more recognizable to the immune system and may increase the likelihood of response to immune checkpoint inhibitors.

EST TMB näitab kasvaja DNA-s leiduvate mutatsioonide koguarvu ning väljendatakse tavaliselt mutatsioonidena megabaasi kohta (mut/Mb).

Kõrge TMB tähendab, et kasvajas on palju mutatsioone, mille tulemusena tekib rohkem ebanormaalseid valke. Need muudavad kasvaja immuunsüsteemile paremini äratuntavaks ning võivad suurendada ravivastust immuunkontrollpunkti inhibiitoritele.

MSI

Tumors with high microsatellite instability (MSI-H) often respond well to immunotherapy because the DNA repair system is impaired, leading to the accumulation of mutations and, often, an increase in TMB.

MSI-H or dMMR tumors may respond well to immune checkpoint inhibitors regardless of the tissue in which the cancer originated. This was one of the first biomarker-based, tumor-agnostic indications for immunotherapy.

EST Kõrge mikrosatelliitide ebastabiilsusega (MSI-H) kasvajad reageerivad sageli hästi immunoteraapiale, sest DNA parandussüsteem on häiritud, mis põhjustab mutatsioonide kuhjumist ja sageli ka TMB suurenemist.

MSI-H või dMMR kasvajad võivad hästi reageerida immuunkontrollpunkti inhibiitoritele sõltumata sellest, millisest koest vähk alguse sai. Tegemist oli ühe esimese biomarkeripõhise, kasvajatüübist sõltumatu immunoteraapia näidustusega.

Although DNA sequencing is available in many cases through the public healthcare system, Exacta combines tumor tissue DNA analysis with ctDNA testing from blood. Studies have shown that some important biomarkers may be detectable only in the blood or only in tumor tissue. Therefore, simultaneous analysis of both sources provides the most comprehensive overview of the tumor’s molecular profile.

 

EST Kuigi DNA sekveneerimine on paljudel juhtudel kättesaadav ka avalikus tervishoius, ühendab Exacta kasvajakoe DNA analüüsi ja verest määratava ctDNA uuringu. Uuringud on näidanud, et osa olulisi biomarkereid võib olla tuvastatav ainult veres või ainult kasvajakoes. Seetõttu annab mõlema allika samaaegne analüüs kõige täielikuma ülevaate kasvaja molekulaarsest profiilist.

Exacta includes

  • tumor tissue DNA panel analysis
  • circulating tumor DNA (ctDNA) analysis

Time to results

The Exacta patient report is available within approximately 14 days.

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