Kalbe Genomics Laboratory - Your reliable partner in ... · Kalbe Genomics Laboratory Know Your...

Jalan Ahmad Yani No 2 Pulomas Komplek Bintang 7 Jakarta INDONESIA, 13210 http://kalgenlab.wordpress.com Email: [email protected]

Kalbe Genomics Laboratory

Know Your Gene, Take Control

mailto:[email protected]


Company

Jalan Ahmad Yani No 2 Pulomas Komplek Bintang 7 Jakarta INDONESIA, 13210 http://kalgenlab.wordpress.com Email: [email protected] 2

“...We are in a new era of the life sciences,

and the truth of that statement can be seen

in fields from medical imaging, to new bio-

logic drugs, and even to the use of DNA

technology to improve our environment and

reduce greenhouse gasses. But in no area

of research is the promise greater than in

the field of personalized medicine.”

Senator Edward M. Kennedy (D – Mass.)

Remarks on the Senate’s Consideration of the Genetic Information

http://kalgenlab.wordpress.com




Table of Contents

Genetized Medicine 1

Personalized Medicine with a twist of molecular genetic 1

About KALGEN Laboratory 2

KalGen Way of Genetic Test 3

Science behind the tests 3

KRAS Mutation 4

Treatment optimization in colorectal cancer 4

Certifications in KRAS mutation test 4

EGFR Mutation Test 5

Treatment optimization in non-small cell lung carcinoma (NSCLC) 5

Our Partners 6

International stakeholders include hospitals and pharmaceutical firms 6

Available genetic tests 7

KalGen Laboratory

Jalan Ahmad Yani No 2 Pulomas Komplek Bintang 7 Jakarta INDONESIA, 13210 http://kalgenlab.wordpress.com Email: [email protected] i





Genetized Medicine

Personalized Medicine with a twist of molecular geneticMedicine has always been personal. When a patient enters doctor’s office, he or she is not just a statistic. In our

times however, we take a step further and deeper. We now read genetic barcode of individual patients and

match them with most suitable treatment options.

Patients, their caregivers, and doctors will now be able to pinpoint specific genes and match them up with

drugs that are most likely to cure or control their diseases. These genetic analyses or we say ‘genetized

medicine’ saves money, preserves quality of life, and fosters peace of mind.

This is a brave new world where time is the essence. Getting the genes tested is key to get the right drugs for

the right patient first time around.

Kalgen Laboratory Bifarma Adiluhung


Patients, their caregivers, and doctors

will now able to point specific genes and

match them with drugs that are most

likely to cure or control their diseases.





About KALGEN LaboratoryWe are a team of active scientists in areas of molecular genetics, cancer biology and immunology who support,

educate, and promote the application of personalized medicine. We evaluate authoritative clinical literatures in

pharmacogenetic studies, pick the biomarkers endorsed by NCCN, ESMO, ASCO, and validate these

biomarker testing in our laboratory.

To ensure our technical validity we participate in international proficiency testing schemes. In 2010, we are

certified by European Society of Pathology (ESP) in KRAS External Quality Assurance Scheme and United

Kingdom National External Quality Assessment Scheme (UKNEQAS) in Molecular Genetics.



We evaluate updated peer-reviewed

literatures in pharmacogenetic studies,

pick the most promising biomarkers,

and validate them in our laboratory.





KalGen Way of Genetic Test

Science behind the testsWe are not just a DNA sequencing laboratory. We pay close attention to the biology of the cancer we are

testing. Genetic testing laboratory must be aware of the complexity of the test, the source of the samples, the

analytical sensitivity of the chosen methods, and the interpretation of the results. We ensure that the DNA we

are testing came from the cancer cells instead of the normal cells. We evaluate our technical sensitivity prior to

making recommendation to referring clinicians of what our test results meant for the patients.



We are not just a DNA se-

quencing laboratory. We

pay close attention to the

biology of the cancer we

are testing.





KRAS Mutation

Treatment optimization in colorectal cancerRecent guideline issued by NCCN has recommend testing for KRAS mutation prior to prescription of anti EGFR

monoclonal antibodies cetuximab and panitumumab. While colorectal cancer patients with mutated KRAS gene

do not benefit from anti EGFR, patients with normal KRAS gene have better chance favorable outcome.

Certifications in KRAS mutation testKalGen laboratory is the only private laboratory in Southeast Asia that has been certified for KRAS genetic test

from two international proficiency test organizers UKNEQAS and European Society of Pathology (ESP). In 2010

alone KalGen laboratory has tested 132 cases of colorectal cancer of which 32% found to be mutated in codon

12 or 13 of KRAS gene. The result mirrors other publications that the prevalence of KRAS mutation is between

30 to 40%. This is the first glimpse of the prevalence of KRAS mutation in Indonesia.



WT68%

Mutant32%

2010 KRAS mutation prevalence





EGFR Mutation Test

Treatment optimization in non-small cell lung carcinoma (NSCLC)Recent guideline issued by NCCN has recommended the testing of EGFR mutation prior to prescription of

tyrosine kinase inhibitor erlotinib to non-small cell lung carcinoma (NSCLC). Patients harboring certain EGFR

mutation have higher chance of responding to erlotinib than those without. Similarly, another TKI gefitinib has

been proved to increase progression-free survival rate in patients bearing activating EGFR mutation.



KalGen has been certified for participation in EGFR

mutation proficiency testing by UKNEQAS (United

Kingdom National External Quality Assessment Scheme).

In annual meeting Asian Oncology Summit 2011 KalGen

has reported the feasibility of routine EGFR testing from

samples collected from cytological slides. The results

showed that the prevalence of EGFR mutation from

Indonesian NSCLC patients submitted to KalGen was

similar to published literatures reporting Asian patients. 0%

25%

50%

75%

100%

male female

22%

0%

56%

9%

22%

91%

EGFR mutation prevalence

EGFR wild type EGFR exon 19 delexon 21 mutation





Our Partners

International stakeholders include hospitals and pharmaceutical firms

We provide genetic testing to many major hospitals whose doctors need answers regarding their patients

genetic status. Personalization of medicine also affects the way drugs being prescribed. KalGen has signed

agreements with AstraZeneca and Merck in pursuing affordable genetic test of EGFR and KRAS mutations for

deserving NSCLC and colorectal cancer patients, respectively







Available genetic tests

Biomarkers Drugs Indications

KRAS Mutation Cetuximab (Erbitux), Pani-tuzumab

Colorectal cancer

EGFR overexpression Nimotuzumab (TheraCIM) Glioblastoma, head and neck cancer, other indication

BRAF Mutation Prognostic marker Malignant melanoma, thyroid cancer, colorectal cancer, lung cancer

EGFR Mutation Tyrosine kinase inhibitor (Geftinib/Iressa, Erlotinib/Tarceva)

Non Small Cell Lung Carci-noma

MGMT methylation Temozolomide (Temodal) Glioblastoma

Estrogen and Progesterone recep-tors, HER2, Topoisomerase 2 Alpha, Ki67, p53,Cathepsin D expressions

Prognostic & Predictive to hormonal therapy, tras-tuzumab (Herceptin), doxo-rubicin

Breast cancer

CISH HER2 Trastuzumab (Herceptin) Breast cancer

Mammaprint (70 genes microarray) Chemotherapy Breast cancer

HLA Genotyping Research, Transplantation







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