Haims: Blood testing has made miraculous advancements
Blood testing has been a useful tool for informing medical providers about how your body is functioning. With just a little bit of blood drawn, often at a medical office or hospital, medical providers have been able to diagnose many common ailments such as nutritional deficiencies, hormone imbalances, blood clotting concerns, heart disease, and diabetes, to name a few.
For decades, scientists and the global pharmaceutical industry have been working on developing blood testing systems that are not expensive or invasive. The Holy Grail would be a convenient and cost-effective device that could be widely accessible, found at pharmacies and at grocery store clinics, and minimally invasive.
Remember Elizabeth Holmes and the debacle of Theranos, the start-up company that claimed it would revolutionize the blood-testing industry? Well, now early detection tools that use small amounts of blood are coming to market.
Until recently, cancer screening involved the use of costly and invasive procedures. Now, early detection screening may use a testing method called multi-cancer early detection blood tests. MCEDs are a new type of blood test that detects cancer at its earliest stages.
Also called a “liquid biopsy,” MCEDs use a small sample of blood, often about a pea size amount, to identify specific biologic signals in DNA, RNA or proteins released by cancer cells into the blood. Then, via the use of artificial intelligence, medical providers can better pinpoint where cancer most likely originated.
MCEDs are not meant to be a replacement for traditional cancer screening tests such as mammograms or CT scans. Rather, they are meant to be a supplement and assist in detecting other cancer types for which specific screening tests do not look. Ultimately, they may be one of many tools used to mitigate invasive testing.
Currently, the manufacturers of these tests claim that they can screen for up to as many as 50 cancer types. These tests are not perfect and there are false positives and false negatives. However, the tests are being refined at a very fast rate. Potentially, these tests may dramatically enhance a patient’s life by providing early detection and assisting medical providers in locating and confirming the presence of cancer.
The GRAIL Galleri test is not yet FDA-approved, but is available under an FDA provision called laboratory-developed tests (the testing itself is done in a central laboratory) and costs patients about $950 out of pocket. A more affordable test called the OneTest costs about $190 and screens for about 20 cancer types.
Blood testing for the early stages of Alzheimer’s has also made leaps and bounds. Currently, the testing involves detecting the formation of the protein, amyloid beta peptide (Aβ). While not completely understood, researchers believe that the presence of Aβ may be the main cause of Alzheimer’s.
Researchers do know that the presence of Aβ destroys synapses (the gap between two neurons, where nerve impulses are relayed) and leads to nerve cell death. Detecting the presence of Aβ early on would both enable early diagnosis and assist in developing strategies to intervene before irreparable brain damage occurs.
Detecting Alzheimer’s is complicated and expensive. Currently, in order to diagnose Alzheimer’s using the guidelines set in 2011 by the National Institute on Aging and the Alzheimer’s Association, medical providers must detect three distinct components of Alzheimer’s pathology; the presence of amyloid plaques, tau tangles and neurodegeneration in the brain; either by PET, CT or MRI imaging or by analyzing cerebrospinal fluid.
Although blood testing for Alzheimer’s is demonstrating positive results, such testing is not meant to be a replacement for other diagnostic methods. Rather, testing is meant to be a part of an overall assessment strategy that takes into account both clinical information and other testing.
Big pharma, Roche, recently received FDA approval for a minimally invasive blood-based biomarker test called the Elecsys Amyloid Plasma Panel. According to Roche, “The Elecsys Amyloid Plasma Panel test detects and measures Alzheimer’s disease biomarkers in blood plasma to indicate the need for further confirmatory testing for Alzheimer’s disease.”
Advances in blood testing technologies will be transformative in the early detection of many diseases. Further, this type of testing is minimally invasive, scalable, and may greatly reduce medical costs.