How NeXT Personal™ May Improve Cancer Treatment Outcomes and Raise the Standard of Care
It’s well known that early detection and accurate screening methods are essential to treat cancer in patients effectively. To accomplish that goal, doctors have long focused on detecting Molecular Residual Disease, or MRD, to diagnose recurrent cancers. MRD refers to a small number of cancer cells that remain in the body following medical treatment, which can lead to relapses in patients.
However, the methods traditionally used by physicians to detect MRD – such as CT, PET, and MRI scans – are often limited in sensitivity. Research into liquid biopsy technology has shown promise as a potential solution to some of these problems. That’s why we believe that physicians can heighten their standard of care by utilizing liquid biopsy technologies.
The Science Behind Liquid Biopsies
For a traditional biopsy, physicians remove a tumor tissue sample through surgical means before submitting it for testing. Depending on the cancer type, stage, and tumor location, these procedures can be highly invasive or impractical. Patients that suffer from late-stage cancers may fail to make a full recovery following a traditional biopsy, and those with early-stage disease may lack the necessary tumor sample size.
Liquid biopsies, on the other hand, are comparatively minimally invasive and typically require just a small blood, saliva, urine, or spinal fluid sample.
So how do liquid biopsies work? Cancer is a genetic disease caused by DNA alterations at the molecular level. Oftentimes, alterations such as mutations affect DNA’s ability to replicate and repair itself, which can lead to cancer. When portions of this altered DNA are shed into a person’s circulation, they are referred to as circulating tumor DNA, or ctDNA for short. Researchers have found they can differentiate between ctDNA and that of normal cells by identifying the presence of abnormalities such as mutations and modifications. Liquid biopsies function by detecting ctDNA in a patient sample and show promise as a valuable tool for oncologists treating tumors too challenging to assess by traditional means.
Which Patients May Benefit Most From Liquid Biopsy Technology?
While liquid biopsies may not replace their traditional counterparts in a clinical setting, they have shown to be an excellent option to use in conjunction with more conventional cancer detection methods. And some patient populations may especially benefit from the unique properties of liquid biopsies.
Certain cancers such as those of the pancreas, kidneys, and ovaries are notoriously difficult to detect at their earliest stages. Clinical trials have demonstrated that liquid biopsy tests can detect these cancers at rates much higher than other available options. Physicians can use liquid biopsies to screen for and catch these cancers in patients that otherwise may have waited until symptoms appeared.
If successful, treatments such as surgery and chemotherapy can debulk or decrease tumor volumes to levels that are too small for biopsy. What’s more, some cancers exist in areas that are exceedingly dangerous to operate on. Additionally, patients at later stages of cancer development may still require diagnostic testing to determine their health status near the end of their treatment plan. Liquid biopsies show promise as potential solutions to use in these unique circumstances.
The Personalis NeXT Personal Approach
While liquid biopsy technology continues to improve, most available ctDNA tests today are limited in terms of specificity and sensitivity. This can be especially problematic when tests lead to false-negative findings.
It is clear from clinical studies that all available liquid biopsy tests detect cancers at higher rates as patients experience later stages of malignancy. For example, a 2020 study found that test sensitivity doubled from 40 to 80% in patients with stage I and III cancers, respectively. This makes sense as more mutant ctDNA is shed into the bloodstream as cancers progress and tumor volumes increase. Other studies have shown that sensitivity also differs depending on cancer type, with some varieties such as glioblastoma resulting in 40% lower prevalence of ctDNA than small cell lung, breast, and colorectal cancers. NeXT Personal overcomes these challenges by providing the highest sensitivity MRD assay available. In fact, NeXT Personal boasts a sensitivity 10 to 100 fold greater than other MRD solutions, which can help clinicians to diagnose and treat their patients earlier and with better accuracy.
With a unique, personalized (tumor-informed) whole genome sequencing solution, the NeXT Personal approach has also been developed to improve specificity in MRD performance. In addition to having shown a specificity of greater than 99.9% in performance characterization studies, physicians can utilize the expansive data provided with NeXT Personal to track thousands of tumor-informed variants based on a patient’s unique tumor profile. This enhanced specificity limits the potential for error while allowing oncologists to assess a patient’s ideal treatment path with greater resolution.
What’s more, NeXT Personal has been developed to require limited material from patients, using only a small blood, plasma, or cfDNA sample and 1 mm3 of tumor tissue to deliver a quantitative, comprehensive molecular characterization. Through our collaborations with some of the leading academic medical centers, we are working to ensure that clinicians have access to this NeXT generation of liquid biopsy testing.