NEW YORK—Provista Diagnostics Inc. presented two posters at December’s San Antonio Breast Cancer Symposium (SABCS) related to its blood-based diagnostic test, Videssa Breast. The combined findings demonstrate a positive prognosis for the test, particularly regarding favorable results for women with dense breasts that have proven harder to diagnose.

 

“The data we [presented] at SABCS demonstrate[s] the important role that Videssa Breast can play in improving breast cancer detection and bringing greater clarity in clinical decision-making,” said Dr. Judith Wolf, chief medical officer of Provista Diagnostics. “Despite advances in imaging technology, clinicians still face challenges in breast cancer detection, particularly in women with abnormal findings or dense breasts.”

 

Provista’s Videssa Breast is billed by the company as the first protein-based blood test for breast cancer that can both help rule out cancer and help accurately identify patients who may or may not need a biopsy for women with abnormal or complex imaging results. The test combines serum protein biomarkers and tumor-associated autoantibodies to generate a unique protein signature for breast cancer detection. 

 

The SABCS posters demonstrated evidence regarding how this blood-based test can help address key issues in breast cancer detection, helping to distinguish benign findings from invasive disease and replicability of findings. 

 

Provista has supported two large, prospectively collected, blinded, randomized, multicenter clinical trials in collaboration with 11 breast cancer centers across the United States. The trials enrolled women ages 25 to 75 with abnormal imaging findings: BI-RADS 3 (probably benign) or BI-RADS 4 (suspicious) in which imaging does not conclusively identify cancer.

 

The data shared at SABCS indicate that Videssa Breast could play a critical role in improving breast cancer detection in women and bring greater clarity in clinical decision-making. Research indicates that breast density does not affect the result of Videssa Breast, which tackles a persistent diagnostic challenge that clinicians face. This research also demonstrates Videssa’s ability to generate reproducible results over time.

 

“Clinicians need more tools to confidently rule out breast cancer or assess when further testing is truly warranted,” said Wolf. “These data demonstrate the ability of proteomic technologies to detect breast cancer early, improve decision-making and reduce the uncertainty and stress for women that too often come with breast cancer detection.”

 

Women with dense breasts are at an increased risk of breast cancer. Increased breast density can obscure lesions on imaging and make detecting breast cancer early more difficult in these patients. Provista’s data demonstrates the potential to sort out who needs what kind of imaging and when, particularly in women with dense breasts. Women in the high density category can have tumors as much as 40 percent more advanced by the time it is detected. 

 

Videssa is a CLIA-approved laboratory test which, as a laboratory-developed test, does not require FDA approval under the current regulatory framework. Currently, it is in limited clinical use through an early-access program, with a wider commercial launch expected in mid- to late-2017. Provista is currently working to initiate a registry study that will broaden the test’s access to patients of participating physicians. This study, plus collaborations with various partners (yet to be announced), will result in several thousand new cases for trials and studies.

 

Provista’s blood test uses the company's proprietary Proteomark technology to bring clarity when the diagnosis is uncertain. Their intention is to develop further diagnostics for breast and gynecologic cancers that can be extremely challenging to diagnose. They are applying this technology first to Videssa Breast and hope to expand the test to include Videssa Ovarian, Videssa Endometrial and Videssa HPV.

 

Provista also recently joined the White House Cancer Moonshot’s Blood Profiling Atlas Project. The Blood Profiling Atlas Project is a collaborative effort among more than 20 organizations in biotech, academia and government that are working to accelerate the development of blood-based cancer diagnostic technologies for patients.

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NEW YORK—Provista Diagnostics in December joined a new collaborative announced in response to the White House Cancer Moonshot, the Blood Profiling Atlas. The Atlas is a collaborative effort among more than 20 organizations in biotech, government and academia, working to accelerate the development of blood-based cancer diagnostic technologies. 

 

Provista’s commitment will center on sharing data generated during the development of Videssa Breast, a protein-based breast cancer blood test and the company’s first commercial product. Provista’s contribution will include data on both the pre-analytic variables including the accuracy, precision and stability of serum protein biomarkers and tumor-associated autoantibodies. 

 

“For the cancer research community, the Blood Profiling Atlas is poised to foster important leaps forward in using blood tests to detect and identify cancers,” said Dr. David E. Reese, president and CEO of Provista. “Establishing rigorous standard methods for serum collection and handling and assessing biomarker significance will be critical to success. We know serum, and we’re pleased to contribute our expertise to help advance this collaboration.”

 

Provista’s contributed datasets will become part of the aggregated, freely available and harmonized Blood Profiling Atlas database, which will also include raw datasets from circulating tumor cells, circulating tumor DNA and exosome assays as well as relevant clinical data (e.g., clinical diagnosis, treatment history and outcomes) and other sample preparation and handling protocols. 

 

“The Blood Profiling Atlas is a smart effort that zeroes in on one of our greatest scientific opportunities to make a difference in the lives of people. As the understanding of both genomic and proteomic approaches continues to grow, we look forward to working with partners to also assess the feasibility of proteomic and genomic approaches used concomitantly from the same sample,” said Reese.