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May
29
Sandeep Singh Dhillon
Blood-Based Breast Cancer Detection Test May Help Avoid Biopsy – Forbes
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By John Nosta

Early detection of cancer is one of the most powerful tools in the management of this disease. And while imaging modalities have advanced the ability to detect early disease, challenges still exist for both clinician and patient. Yet one point remains clear and is a driving principle—early detection saves lives. And the earlier, the better.

A study published in Clinical Breast Cancer examined the utility of blood markers to detect breast cancer. The test that was evaluated is called Videssa Breast and evaluates 11 serum protein biomarkers and 33 tumor-associated autoantibodies. It was studied in women under 50 who had abnormal or difficult-to-interpret imaging (BI-RADS 3 and 4).

Here’s the overall takeaway: The negative predictive value—the likelihood of a patient having no cancer—was 99%. In other words, clinicians may have a powerful tool to identify patients who are highly unlikely to have breast cancer, in instances where the mammogram is abnormal. Overall, imaging resulted in 341 participants receiving follow-up procedures to detect 30 cancers (90.6% FP rate). Videssa Breast would have recommended 111 participants for follow-up, a 67% reduction in false positives. The authors conclude:

Videssa Breast can effectively detect breast cancer when used in conjunction with imaging and can substantially reduce unnecessary medical procedures, as well as provide assurance to women that they likely do not have breast cancer.

While the results are impressive, the clinical path itself can be difficult. Primary care physicians, radiologists and surgeons all play a role in patient management. And the decision for invasive procedures such as a biopsy involves these stakeholders—and the patient. I presented the study to three of these decision-makers for their perspective on a blood-based test used in association with mammography.

The primary care physician:

I see these diagnostic uncertainties after breast cancer screening almost daily. When a mammogram comes back abnormal, I can tell my patient that it appears benign. But with Videssa Breast, I can give her much more powerful reassurance that it is not cancer. Having used the test for some time, my goal is to educate other providers about it, because I’ve seen it serve as a valuable decision-making tool that helps spare women potentially unnecessary biopsy. Most women who get that abnormal imaging result do not have cancer. With the simplicity of a blood test, I can send more of them home with peace of mind.

—Wendell Phillips, D.O., primary care physician with HonorHealth Medical Group in Phoenix, Ariz.

The radiologist:

As a radiologist, images don’t always give us a clear view of a patient’s cancer status. A blood test that offers clinicians the confidence to rule out cancer can help us better select the patients who truly need closer monitoring or that next intervention. In the case of breast biopsy, the test is a powerful avenue for reducing the use of an invasive procedure and still get to best outcomes for women.

—Josie R. Alpers MD, radiologist and study co-author

The surgeon:

Clearly this type of liquid biopsy test is the direction we are going with many cancers. As mammography technology has improved, we are finding many things that we have to act on, but may be clinically insignificant. I can see that increasing with the adoption of this technology—at least until we have gotten over our learning curve. However, there is no question that patients who have a BIRADS 3 mammogram and high anxiety about six-month follow up may be relieved by a negative Videssa test.

—Deanna Attai, M.D., past president, the American Society of Breast Surgeons

For solid tumors, the combination of an anatomic view and biological view may hold the promise to more sophisticated detection and management. Further, we may also gain new insights into other pathology such as atypical hyperplasia and how to best manage these conditions. But beyond the deeply scientific aspect of cancer detection lie deep personal and emotional aspects of this disease. The burden is tremendous and the ambiguities of diagnosis can add to the difficulties. A new test, particularly one with a high negative predictive value, can be a potent source of comfort that offers, in and of itself, a level of therapeutic value. And as more data become available, the potential for expanded use of Videssa Breast as a screening tool could be a game-changer in the diagnosis and management of breast cancer.

Feb
24
ragupathyrenganathan
USP Updates <61> and <62> for Microbial Testing of Non-Steriles
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Jul
8
sandeepsd
Biorelevant dissolution media as a predictive tool for glyburide a class II drug – ScienceDirect Elsevier
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Jun
25
ragupathyrenganathan
Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT)
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Jun
25
ragupathyrenganathan
Application of differential scanning calorimetry (DSC), HPLC and pNMR for interpretation primary crystallisation caused by combined low and high melting TAGs
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Jun
23
sandeepsd
The effect of polymer properties on direct compression and drug release from water-insoluble controlled release matrix tablets – Science Direct
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The objective of this study was to identify and evaluate key polymer properties affecting direct compression and drug release from water-insoluble matrices. Read more …

Jun
4
ragupathyrenganathan
Current trends in modern pharmaceutical analysis for drug discovery
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Jun
4
ragupathyrenganathan
Integrated high capacity solid phase extraction-MS/MS system for pharmaceutical profiling in drug discovery
Analytical Discussion
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Jun
4
ragupathyrenganathan
Multivariate PAT solutions for biopharmaceutical cultivation: current progress and limitations
Analytical Discussion
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Jun
1
ragupathyrenganathan
Pharmaceutical impurities and degradation products: Uses and applications of NMR techniques
Analytical Discussion
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