Israel | The Ministry of Health has approved the use of a new test to diagnose prostate cancer

These days, a new test has been approved for use by the Ministry of Health that makes it possible to assess the risk of the presence of aggressive prostate cancer with a high level of accuracy. The new blood test is called IsoPSA and it allows patients to avoid a painful and unnecessary invasive biopsy. The significant innovation stems from the fact that the advanced decoding technology detects the change in the resulting protein structure Only from a cancerous tumor. The exact test result allows the doctor to determine whether it is a patient with prostate cancer more reliably.To date, other tests for prostate cancer, including the new ones, have allowed to measure only the change in the concentration of the PSA protein, (not in the structure like the new test) which is affected by many other factors other than cancer such as benign enlargement of the prostate, inflammation of the urinary tract and the use of drugs. This is the reason why in many cases a biopsy conducted following other tests yielded answers that were only suspected to be cancer but were of no clinical significance. For example, out of a million biopsies performed in the United States, only 250,000 were found to be cancerous, meaning 75% of the tests came out negative and therefore may have been unnecessary.

 

The effectiveness and reliability of the new test was recently proven in an international clinical study conducted in a large number of leading medical centers in the world. The Israeli part of the study took place in the urology department, at the Rabin-Blinson Medical Center under the leadership of Prof. Jack Baniel. Following this, another clinical study was conducted at the leading medical center Cleveland Clinic With the new test, which included 900 patients. The study showed that in 66% of the cases, the doctors changed their original recommendation (which was based only on the level PSA and other clinical data) after seeing the result of the IsoPSA test, and not least, the use of the test resulted in a 55% reduction in the number of biopsies actually performed. This means that the result of the new test is a very significant tool for the attending physician, which allows to assess the risk in a more informed and accurate way and to save the patient in many cases an invasive, painful and unnecessary biopsy.

“dramatic innovation”

“The blood test is a dramatic innovation that allows us as doctors to more accurately diagnose prostate cancer, which is the most common type of cancer in men in Israel,” says Prof. Ofer Nativ, an expert in urological surgery, a lecturer at the Technion’s Faculty of Medicine and former director of the urology department at the Bnei Zion Medical Center in Haifa. , who serves as a scientific advisor for testing in Israel. “It is important to us to provide patients with the most advanced test that the world of science has developed, which has proven reliable in clinical studies in order to prevent unnecessary biopsies of cases without a tumor or the discovery of malignancies that have no clinical significance. This means that thanks to the decoding of the new test, we can send for a biopsy only those who who is at real risk of aggressive prostate cancer.”

The test was included in the updated clinical guidelines of the NCCN – the body that unites 32 leading cancer centers in the United States which now recommends the use ofIsoPSA In order to more effectively define the probability of aggressive prostate cancer before biopsy. When submitting it for the approval of theFDA The test was defined by the American Food and Drug Administration – FDA as a breakthrough test, a definition that is only given to about 3% of requests. These days it is being marketed in the United States after receiving the CLIA and CAP authorizations required for American laboratories to market tests and now after receiving the approval of the Ministry of Health – also in Israel.

The most common cancer among men

The “Cancer Association” states that prostate cancer is the most common malignancy and the fourth leading cause of death from cancer among men in Israel and worldwide. According to the data of the Ministry of Health and the association, every year about 2,700 new prostate cancer patients are discovered in Israel and about 420 men die from the disease.

According to data from the World Health Organization, prostate cancer accounts for 7.3% of all cancer cases worldwide and about 3.8% of cancer deaths. Every year, 1,414,259 new patients with prostate cancer are diagnosed in the world and 375,375 men die from the disease.

The new test is intended for men aged 50 and over with PSA values ​​above 4 in a regular test and requires a referral from a urologist. Its cost is NIS 2,990 and as of today it is already included in most private health insurances in Israel. Insureds of “Kallit Perfect” can already receive a refund of 75% of the cost and soon other health funds are also expected to join. Blood sampling for the IsoPSA test is carried out in several laboratories, clinics and institutes throughout the country. The blood samples are sent frozen to a laboratory in the United States for the purpose of performing the test and decoding, and the answer is received within 10 days by e-mail to the patient and the attending urologist. The results come as a numerical value that clearly reflects a positive or negative result that allows a simple and accurate interpretation by the doctor and the patient. To order the test, you can call the 24/7 staffed call center at the number 5901* or go to the website.