A new diagnostic tool has been approved by the U.S. Food and Drug Administration (FDA) to help researchers identify leukemia and lymphoma cells by using a technique known as flow cytometry. A flow cytometry test for non-Hodgkin’s lymphoma (NHL) can help determine whether normal or abnormal DNA is present in the cancerous cells, as well as the rate at which the tumor is growing. Flow cytometry involves placing light-sensitive dye, or fluorescent antibodies, on cancerous cells and putting them under a laser beam. The DNA in the cancerous cells is then analyzed by observing which parts of the cells absorb light, thus determining if the patient has a blood cancer and identifying the subtype of the disease.
What is the tool?
The ClearLLab Reagents, developed by Beckman Coulter, is intended to detect leukemia and lymphoma cells. The standardized kit is used to recognize markers that are characteristic to many malignancies, such as acute leukemia, chronic leukemia, non-Hodgkin’s lymphoma, and more. In combination with flow cytometry, it identifies and pinpoints specific cell populations from various samples, including blood samples, lymph nodes, and bone marrow.
Before being approved, the ClearLLab test was reviewed in a study that analyzed 279 samples. At the time, the standardized kit allowed for a correct diagnosis of 93.4%, with accuracy in the detection of cancerous cells by around 84.2%. The results were compared with those from other diagnostic tests and researchers found that the ClearLLab test was able to provide accurate and reliable results for individual antibodies. The FDA determined that ClearLLab test, along with new performance methods, would be able to guarantee safety and effectiveness in the detection and diagnosis of leukemias and lymphomas.
If you are concerned about symptoms associated with Hodgkin’s lymphoma, it is important to see your doctor for a proper diagnosis. He or she will give you a physical examination and ask you questions relating to your health, daily lifestyle, and medical history. If they refer you for further testing, you will need to undergo a biopsy. A biopsy is a small operation that involves removal of some of an affected lymph node (known as fine needle aspiration biopsy) or all of an affected lymph node (known as core needle biopsy). The tissue sample is then sent to a laboratory to be studied and to confirm a diagnosis of Hodgkin’s lymphoma. Determining the type of Hodgkin lymphoma is a very crucial element in planning for your treatment.
If the biopsy confirms that you have Hodgkin’s lymphoma, you will need to undergo further diagnostic tests to see how far the lymphoma has spread throughout your body. Such diagnostic tests may include the following:
- Computerized tomography scan (CT scan) – this scan takes x-ray images of different parts of your body and conducts a 3-D image to determine the spread of the cancer;
- Positron emission tomography scan (PET scan) – this scan measures the cellular activity of different parts of your body to determine the spread of the cancer; a PET scan is typically taken at the same time as a CT scan;
- Magnetic resonance imaging scan (MRI scan) – this scan involves the use of strong magnetic fields to conduct a detailed image of different parts of your body to determine the spread of the cancer;
- Chest x-ray – this scan takes x-ray images to check whether the cancer has spread to your chest or lungs;
- Pulmonary function test (PFT) – this test measures how much air your lungs can hold, how quickly air moves in and out of your lungs, as well as how quickly your lungs take in oxygen and release carbon dioxide from your blood;
- Echocardiogram (ECHO) – an evaluation is performed on your heart to determine whether it is functioning properly;
- Bone marrow sample – a sample of your bone marrow is taken from your pelvis to determine whether the cancer has spread to your bone marrow;
- Blood test – a sample of your blood is taken to check your red and white blood cell count and see how well your liver and kidneys are functioning
The list above describes all the possible diagnostic tests that use x-rays, magnetic fields, and radioactive particles to detect lymphoma. However, each test varies from individual to individual. Your doctor will take into consideration the following factors before recommending the proper diagnostic test for you:
- Your age
- Your medical history
- Your signs and symptoms
- The type of cancer suspected
- Your overall well-being
Once the diagnostic tests are carried out, it should be possible to identify the stage of your lymphoma, or how far the cancer has spread throughout your body. The stages of Hodgkin’s lymphoma include the following:
- Stage 1 – The cancer has affected one group of your lymph nodes, such as your groin nodes (either below or above the diaphragm) or your neck;
- Stage 2 – The cancer has affected two or more lymph node groups, either below or above the diaphragm;
- Stage 3 – The cancer has affected the lymph node groups below and above the diaphragm;
- Stage 4 – The cancer has spread throughout the lymphatic system and made its way into your bone marrow or organs
Doctors also tend to add the letters “A” and “B” to your stage, which indicate whether or not you are experiencing particular symptoms. For instance, “A” is generally put after your stage if you are experiencing no other symptoms apart from swollen lymph nodes. “B”, on the other hand, is put after your stage if you are experiencing other symptoms such as high fever, night sweats, or weight loss.
Doctors may perform imaging tests to determine if the cancer has spread to other areas of your body or they may recommend tests to learn more about possible treatment options for your condition. The results from your tests may take up to several weeks and it is only natural to feel anxious and concerned while you wait. Although, keep in mind that your doctor collects significant information pertaining to your medical condition during this time. They need to gather as much information as possible in order to determine what type of treatment plan is right for you. If you feel that your symptoms are starting to change or if you are concerned about anything relating to your health, do not hesitate to contact your doctor and schedule an appointment.
The importance of clinical trials
Clinical trials are continuously advancing in research and scientific understanding relating to a disorder or disease. They are important in ensuring the safety of new discoveries and they take into account specific scientific data and not just the opinions of doctors or patients. They help to ensure and guarantee the safety and well-being of individuals, such as you.
Several different diagnostic tests are carried out to recognize and diagnose lymphoma, determine the stage of the cancer, and show whether treatment is working. For this reason, every new diagnostic tool uncovered is of great advantage to doctors and to patients. In addition to making it possible to receive fast and accurate results, diagnostic tools also make it possible to receive the best possible treatment options available. However, despite successes with new treatments relating to lymphoma, such as flow cytometry, continuous studies need to be conducted. Clinical trials are necessary for uncovering new medications, diagnostic tools, and treatments that will eventually be approved for use in the healthcare setting.