NEW YORK (GenomeWeb) – With a fresh round of funding in hand, Provista Diagnostics is moving ahead with a pair of clinical trials for its dtectDx-Breast proteomic breast cancer diagnostic.
The Scottsdale, Ariz.-based company said last week that it had completed a Series B funding round, raising $6 million from existing investors. According to Provista CEO David Reese, the money will largely go toward funding the firm's two ongoing prospective clinical trials – the first evaluating the dtectDx-Breast test in women under the age of 50 years and the second in women from 25 to 75 years of age.
The company plans to present the results of the first trial at a "national or international conference" sometime this year, Reese told ProteoMonitor, with the aim of having data from the second shortly thereafter. Provista plans to launch the test initially out of its CLIA lab with the ultimate goal of taking it through US Food and Drug Administration 510(k) clearance.
"Obviously these studies are expensive, so a decent amount of the proceeds [from the Series B round] will be used to fund that trial," Reese said. He added that the company was committed to generating a substantial quantity of prospective data in support of the test's launch.
"We rely on retrospective studies to develop models, but really we think that any test in the marketplace should have strong prospective data rather than just retrospective data behind it," he said.
The dtectDx-Breast test is aimed at aiding physicians in determining whether or not to pass patients with suspicious lesions on for a biopsy. Mammogram findings are classified according to the BI-RADS system, which assigns findings a number from one, meaning negative, to five, meaning a high likelihood of breast cancer requiring biopsy.
Determining whether to biopsy patients scoring in the middle range – BI-RADS 3 and 4, in particular, is currently a challenge for the field, Reese said, noting that this is the population the company is targeting with the dtectDX-Breast test.
"Patients who have been scored as a BI-RAD 3 or 4 are at a key decision point," he said. "BI-RAD 3 [patients] largely do not get biopsied, whereas BI-RAD 4 [patients] largely do."
The goal, he said, is to use the test as a supplement to imaging to determine which patients in these categories should be biopsied and which can forego the procedure.
There is particularly high interest in a rule-out test, Reese said, noting that "when we talk to key opinion leaders there is a lot of concern about overdiagnosis. Clinicians have said to us that if we can produce a test that reduces the overdiagnosis of breast cancer, then that is something they are interested in. So that's the paradigm we are interested in."
In this, the company's plans are similar to proteomic approaches being pursued by several parties in lung cancer, where there is also significant need for a rule-out test that can be combined with imaging to reduce unnecessary biopsies. Proteomics firm Integrated Diagnostics, for instance, last October launched its Xpresys Lung, which is intended for ruling out as potentially cancerous lung nodules identified during CT scans.
Launched in 2004 as Provista Life Sciences, the company initially positioned 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.
In this manner it developed a diagnostics pipeline covering a number of disease areas including Alzheimer's, Parkinson's, ovarian cancer, and lung cancer. It also developed its original breast cancer test, called the BT Test, that it sold in Ireland and the UK through International Health Technology.
Upon becoming CEO in 2011, Reese refocused the company on women's cancers and began the process of revamping its breast cancer program. In January 2013, Provista launched a 350-patient prospective trial for its breast cancer early detection test, now called DtectDx Breast. That trial is evaluating the test in women under 50 years of age.
The second prospective trial will look at the test in women from age 25 to 75. The company decided to launch this second study based on recent development work, Reese said.
"The first algorithm worked well in women under 50 and decently in women over 50, but we didn't think it performed to a level [in women over 50] that was really commercially exciting," he said. New research, however, led to development of a panel that the company deemed worth testing in the second study, he noted.
In addition to its internally developed breast cancer biomarkers, Provista is also working with a set of 28 auto-antibody markers to the disease that it licensed in October from Arizona State University's Biodesign Institute.
The license covers biomarkers for the early detection of breast and ovarian cancer and human papillomavirus identified in the labs of Biodesign Institute researchers Joshua LaBaer and Karen Anderson. Both researchers are members of Provista's scientific advisory board.
The 28 auto-antibody markers originate from research using LaBaer's nucleic acid programmable protein array platform, which uses proteins synthesized in situ directly from printed cDNA vectors at the time of the assay to create large arrays.
In a 2010 study in the Journal of Proteome Research, LaBaer and his colleagues identified the 28 markers from a panel of 5,000 antigens, testing them in a blinded study using 50 cases and 39 benign controls. In that study, each of the biomarkers demonstrated specificity ranging between 75 percent and 100 percent with sensitivities in the 10 percent to 40 percent range.