A leading molecular
diagnostic company has developed and commercialized epigenetic tests to improve
the diagnosis and treatment of prostate cancer.
The data, presented at the European Association of Urology
meeting in Glasgow, UK (October 9-11, 2014), confirmed that the epigenetic
profile of genes generated by the test is solidly associated with established
risk stratification metrics, such as Gleason Score (GS) and the NCCN (National
Comprehensive Cancer Network) risk categories.
In the presented study,
hypermethylation levels of GSTP1, APC and RASSF1 were evaluated on biopsies
from 102 men with
various Gleason's Grade (ranging from 3+3 to 4+4) and NCCN (ranging from very
low to high) risk profiles. All men had gone through a 12-core prostate
under routine clinical practice resulting in their prostate cancer
(Pca) diagnosis. No epigenetic aberrations for any of these three genes were
spotted in 20 control patients, who had non-cancer histology in all of their
12-core biopsy specimens.
For 46 men, the highest
identified GS was 6, classifying these men as potential candidates for active
surveillance; however, 17% (n=8) of them showed an epigenetic
profile that is indicative of higher-grade disease.
Of the nine men with GS
4+3 or higher, 88% (n=8) had several epigenetic aberrations, in addition to 17
out of 27 (63%) of the men with GS 3+4.
When epigenetic profiling
was compared to NCCN risk categories, similar outcomes were obtained,
recognizing 79% (31 out of 39) of the men with intermediate or high NCCN risk
profiles. Approximately one third of the patients in the very low and low risk
categories showed similar epigenetic profiles.
In conclusion, epigenetic
profiling using the genetic
on individual biopsy cores could help identify patients
harboring aggressive prostate cancer, aiding patient management.
How Will This Test
Help With Prostate Cancer in Clinical Practice?
Prostate cancer is a
in the prostate, a gland in the male reproductive system. Most
prostate cancers are slow developing, but some grow relatively fast. These
can spread from the prostate to other parts of the body,
particularly the bones and lymph nodes. They may initially cause no symptoms,
but it can cause difficulty in urinating
blood in the urine in the later stage. Other late symptoms include feeling
tired because of low levels of red blood
Each year 9.75 lakh
American men are diagnosed with a negative prostate biopsy and of these about
25-35% receive false-negative results. With the present standard of care,
prostate biopsy procedures consisting of 10-12 needle
cores only sample approximately 1% of a man's prostate.
This approach leaves men
at high risk of occult cancer, leading to a high rate of repeat biopsies, often
on cancer-free people. There is an urgent medical need for a clinically
effective diagnostic test to address this issue. The current genetic test will
help detect an epigenetic field effect or 'halo' linked with the cancerization
process at the DNA
level. This epigenetic
'halo' around a cancer lesion can be present despite
cells having a normal appearance under the microscope
Which Company is
Marketing the Test Kit
MDxHealth is a well-known molecular diagnostic
company that develops and commercializes epigenetic tests to support cancer
. The company conducts tests based on proprietary gene
(epigenetics) technology and assist physicians with the
diagnosis of cancer, prognosis of recurrence risk, and prediction of response
to a specific therapy.