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Provista Launching Clinical Study of Breast Cancer Dx, Could Submit 510(k) This Year

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New York-based Provista Diagnostics will this month launch a prospective clinical study for its protein biomarker-based breast cancer diagnostic, DtectDx Breast, and could submit a 510(k) for the test to the US Food and Drug Administration sometime this year, CEO David Reese told ProteoMonitor this week.

The company also this month expanded its contract research business, adding to the services offered out of its Scottsdale, Ariz.-based CLIA-certified, GLP-capable laboratory.

The moves are part of what Reese described as Provista's "dual business model," wherein the company aims to develop proprietary diagnostics for diseases including breast, ovarian, and endometrial cancer while simultaneously providing CRO services for outside biotech and pharma firms.

"You've got this big lab, which in order to run well is quite expensive, and you have a tremendous amount of capacity," he said. "So why not run [for instance] companion diagnostic development for other companies or pharma contracts or CLIA contracts."

Provista opened the CLIA facility in May of last year and launched its contract research business in October. Thus far the company has signed deals with "a few" pharma firms, including one for which it is helping develop a companion diagnostic for an agent in phase I trials, Reese said. It has also signed seven CLIA contracts, he said.

Provista launched in 2004 as Provista Life Sciences, positioning itself as a mezzanine developer of molecular diagnostics that aimed to acquire early-stage biomarker tests, advance them to the clinical stage, and then sell them.

It developed in this manner a diagnostics pipeline covering a number of disease areas including Alzheimer's, Parkinson's, ovarian cancer, and lung cancer. It also developed the DtectDx Breast test, which it then called the BT Test, selling it in Ireland and the UK through International Health Technology.

Reese, who has a PhD in biomedical sciences from Vanderbilt University and prior to joining Provista worked at the hedge funds Brencourt Advisors and Yorkville Advisors, became involved with the company as an investor in 2011.

In August 2011, he joined Provista as CEO, whereupon he moved to divide the company in two, spinning out its central nervous system assets into a new company, Memory DX, which is currently run by former Provista CEO William Gartner and recently licensed its LymPro Alzheimer's diagnostic to biotech firm Amarantus BioScience.

"In order to be successful, you have to be laser focused and have a core mission," Reese said, explaining the decision to split up the firm.

Provista as currently envisioned specializes in "molecular oncology diagnostics in women's health cancers – so endometrial, ovarian, uterine, cervical, breast," he said.

The DtectDx Breast diagnostic is the company's lead product. The test, which measures levels of angiogenic factors and inflammatory cytokines, is intended as a supplement to mammograms in women under 50. According to Reese, in a recent blinded, prospective study looking at 184 women, the test correctly identified 27 out of 29 breast tumors. He compared this to mammograms, which miss around 17 percent of breast cancers and have high rates of false positives.

This month, Provista will launch a second prospective trial, this one looking at 350 women of all ages. It plans to use the data from the trial to support its 510(k) submission.

The company, Reese said, is taking the test through the FDA in anticipation of tighter future regulation by the agency of laboratory-developed tests.

"We think that down the road this is going to be a much more highly regulated space," he said. "The timing of that is difficult to determine, but I think that especially as these diagnostics are increasingly used in clinical practice, the FDA is going to want to say something about it."

Reese said Provista currently sells around 50 or 60 LDT versions of the DtectDx Breast tests per month, primarily to small groups of patients in Arizona. "We haven't really launched it except for local users," he said. "We literally just hired a small sales force of three on [Jan. 1]. So [sales of the test] is not something that we've really put a lot of effort into."

Beyond the DtectDx Breast test, the next products in Provista's pipeline are tests for ovarian and endometrial cancer. While DtectDx Breast consists solely of proteins, the company is also exploring other molecular markers including genes and lipids, Reese said. He noted that while Provista is "very active" in looking to acquire potential marker panels developed by outside researchers, the company is also undertaking its own internal biomarker discovery efforts, for which it uses Meso Scale Discovery's array platform.

Reese acknowledged the challenges that efforts to commercialize molecular diagnostics – particularly protein biomarkers – have run up against, but said that as a former investor in the larger biotech/medical sector, he sees molecular diagnostics as "absolutely the most exciting new space," adding that he believes physicians are beginning to fully understand the benefits of these products.

He said, however, that to succeed, companies in the space must "be extremely disciplined with [their] use of capital," and that "a new model for marketing [molecular diagnostics] has evolved."

"You can't sell these tests within 80-menu companies," he said. "Selling molecular diagnostics is not like selling traditional diagnostics. Your reps must be much more educated and you need buy-in from multiple clinical specialties."

To support its activities, including the services expansion and forthcoming clinical study, Provista raised $7.5 million in 2012, with a $5 million sale of Series A preferred stock in February and March followed by a $2.5 million sale of Series A preferred stock in October.

Provista also last year established its scientific advisory board, which includes Arizona State University proteomics researchers Karen Anderson and Joshua LaBaer. Breast cancer diagnostics are one of LaBaer's research areas. In 2010 he published a study in the Journal of Proteome Research on a panel of 28 blood-based protein biomarkers that could aid in the early diagnosis of the disease (PM 12/24/2010).

In an interview with ProteoMonitor following the release of the paper, LaBaer noted the lack of good early detection markers for breast cancer.

"I think it's fair to say that there aren't any good early detection biomarkers," he said. "People have tried, but perhaps because the [early stage] tumors aren't that vascular and perhaps because they don't start a lot of inflammation, it's been very hard to find markers for the disease."

Provista currently has 21 employees, the bulk of which work out of its Arizona facility. Reese said the company maintains its New York headquarters due to the area's collection of leading research centers.

"You have the proximity to thought leaders, an incredible pool of talent to pull from between Columbia [University], [Rockefeller University], [New York University], [Memorial] Sloan Kettering, Cornell [University]," he said.

This is also a benefit for the firm's in-licensing and business development efforts, he noted, adding that given the proximity not only of New York's research centers but also academic hubs like Boston and Philadelphia, "within a few hours in either direction, we have access to a tremendous amount of intellectual property."

According to a recent press release, Provista is looking to expand its laboratory facilities in New York City, though Reese declined to comment on this beyond saying that the company is "evaluating additional laboratory opportunities geographically."

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