NEW YORK—Privately held molecular diagnostics company Provista Diagnostics Inc. recently announced results of a study its researchers conducted that is reportedly the first to demonstrate age-related differences in Tumor-Associated antibodies (TAAbs) in breast cancer screenings. The results suggest strongly that age should be considered when developing diagnostic assays to detect breast cancer. The company presented the study results at the Miami Breast Cancer Conference in March.
The study examined the TAAbs and serum protein biomarkers (SPBs) of 492 women aged 25 to 75 whose results from diagnostic imaging fell into Breast Imaging Reporting and Data System (BIRADS) categories of BIRADS 3 (probably benign) or BIRADS 4 (suspicious), which are considered inconclusive or ambiguous findings.
The study found that age-related differences appeared in a majority of individual protein biomarkers, irrespective of other factors that may affect screening results, such as breast density and cancer prevalence. The data further suggested that age 50 may be a turning point for when changes may occur in TAAb expression, as hormone level changes associated with menopause could be a factor.
“While there have been multiple studies showing SPBs will likely change as a person ages, ours is the first study that shows expression of TAAbs changes with age as well,” says Dr. David Reese, president and CEO of Provista Diagnostics. “This is an important finding and advances the state of the science in the field of proteomics as a whole.”
The company plans to apply the findings of this study to its proteomic test Videssa Breast, a blood test that uses Provista’s patented ProteoMark technology to examine multiple SPBs and TAAbs to indicate the presence or absence of breast cancer. The test is designed to give clinicians and patients actionable information to support decision-making in the event that mammogram results are unclear.
Videssa Breast analyzes the proteins in the blood, using SPBs to measure with a high degree of certainty whether cancer is present and, if so, measures the presence of TAAbs, which are developed by the body to mount an attack against specific cancer cells. The unique signature of breast cancer TAAbs provides the specificity and certainty on cancer type. The combination of imaging with a proteomic test such as Videssa Breast offers a promising detection model that reduces uncertainty from ambiguous results, and reduces the rate of both false negatives and false positives, according to Provista.
Videssa Breast can improve detection of early breast cancer because results are not impacted by breast density, cancer stage or tumor size, which allows for earlier and more accurate diagnoses. The test is designed to give clinicians an unambiguous “yes” or “no” with one of two results—either a low protein signature that signifies the patient does not have breast cancer and that further diagnostic imaging and/or biopsy are likely not needed, or a high protein signature that indicates the patient may have breast cancer and that further diagnostic imaging and/or biopsy are warranted.
“By charting new scientific understanding of changes in both SPBs and TAAbs, we are able to apply it to Videssa to develop a more accurate diagnostic test that provide actionable results and peace of mind to both clinicians and patients,” says Dr. Kasey Benson, diagnostic developmental scientist for Provista Diagnostics.
With the results of their studies, Provista will now be able to produce two variations of Videssa Breast to account for changes in TAAbs due to aging.
“We plan to have Videssa Breast available to patients of all ages later this year,” says Reese. “This summer, Provista is planning to release the combined results of Provista 001 and Provista 002—both rigorous, prospectively collected, blinded, randomized multicenter clinical trials for Videssa Breast.”
“Breast cancer imaging is a critically important tool for the early diagnosis of breast cancer for patients of ages 25 to 75,” reaffirms Benson. “For patients, the accuracy and reliability of Videssa Breast … will mean they have the comfort and confidence that comes with clear, reliable results, and will be able to reduce stress and the burden that comes with additional testing and ‘wait and see’ approaches.”