CanDiag Inc.

CanDiag Inc. spun out of the University of North Carolina at Charlotte to develop an antibody-based blood test for detecting early-stage breast cancer. The start-up will first use the technology to develop a blood test for breast cancer recurrence, but the ultimate goal is to develop a test that can be used for women who have an abnormal mammogram; the test would be performed in lieu of additional expensive imaging studies and before performing biopsies.

[CanDiag Inc.]

804 Wandering Way Drive

Waxhaw, NC 28173

Email: [email protected]

Web Site: www.candiaginc.com

Contact: Pinku Mukherjee, PhD, CEO & CSO

Industry Segment: In Vitro Diagnostics

Business: Antibody-based blood test for early-stage breast cancer

Founded: November 2010

Founders: Pinku Mukherjee; Rahul Puri, PhD, Advisor

Employees: Undisclosed

Financing To Date: Undisclosed

Investors: Undisclosed

Board Of Directors: Taffy Williams, PhD, Chairman

Of all the various tools under development to improve breast cancer care, none are predicted to have as far-reaching an impact in the future as new gene- and protein-based biomarker tests, which are already playing a huge role in the move toward more personalized care for breast cancer patients.

Gene-based tests are particularly helpful for risk stratification, and one test in particular that has been taking the breast cancer arena by storm is the Oncotype DX 21-gene test from Genomic Health Inc. This test provides an Individualized Recurrence Score to indicate the potential benefit a patient might receive from chemotherapy treatment and the likelihood of a breast cancer recurrence within 10 years. It is intended to help guide treatment decisions in cases where physicians are uncertain whether chemotherapy may be of benefit. The CLIA-waived test has wide acceptance among breast cancer clinicians and over 275,000 of the tests have been performed worldwide to date.

According to Genomic Health, Oncotype DX has been experiencing strong procedure growth, with test volume up 15% and product revenue up 17% in the first quarter of 2012. The firm believes the test is now about 60% penetrated into the node-negative breast cancer segment and it expects that to expand further. The company says the Oncotype DX test results in treatment decision changes nearly 40% of the time, saving “hundreds of millions of dollars” by avoiding unnecessary chemotherapy.

Genomic Health’s biggest competitor at the moment is Agendia BV, which markets the 70-gene MammaPrint test, FDA cleared in 2007 to assess recurrence risk in breast cancer patients. Unlike Genomic Health’s assay, which puts patients in low risk, intermediate risk and high risk categories, the MammaPrint test provides only a low or high risk result, which the firm says makes interpretation easier for physicians and patients. Agendia, which has a larger presence outside the US, also has experienced considerable growth of late, particularly after introducing a process that can utilize paraffin-embedded tissue for analysis, rather than fresh frozen tissue samples (all tissue samples are shipped to Agendia for analysis with results available in seven to 10 business days). In addition, the firm has been able to capitalize on results from the five-year RASTER study, which found that 96% of patients classified as low risk on the MammaPrint test did not experience a recurrence over a five-year period, even though many were not treated with chemotherapy.

While the heavy hitters duke it out in the gene-based risk stratification market, scientists across the country are quietly searching for new biomarkers that could further improve breast cancer diagnosis and management. And researchers at start-up [CanDiag Inc.], a recent spin-off from the University of North Carolina at Charlotte, have discovered a blood-based test they believe could be a game-changer for early breast cancer detection.

CanDiag was founded in November 2010 by Pinku Mukherjee, the Irwin Belk Endowed Professor for Cancer Research at UNCC, and Rahul Puri. The company has obtained an exclusive worldwide license to the antibody technology from the university.

Mukherjee, who serves as the start-up’s CEO and CSO, believes the test may be able to accurately detect the disease at its earliest stages. CanDiag has performed a pilot study in blood samples from breast cancer patients, which yielded sensitivity and specificity values of 100%. It is planning larger studies to validate those results.

The test is based on the protein MUC-1, which is also recognized by the common cancer marker CA-15-3, but is much more specific. Mukherjee and her UNCC team developed an antibody (TAB 004) in a triple transgenic mouse model that recognizes the glycosylated form of the protein, which is only present in cancerous cells. “That’s what makes this very different from other tests and tumor markers that are already on the market,” she says.

The pilot study compared the TAB 004 assay with the CA-15-3 assay on blood samples from 40 breast cancer patients and 12 normal, age-matched controls. The TAB 004 test correctly identified all of the breast cancer samples, even those involving noninvasive ductal carcinoma in situ (DCIS), Mukherjee says, while all of the normal samples, which included benign conditions, were below the normal cutoff value for the test. “Of course, the N numbers are small right now, so we need a bigger study, but what we have currently looks very specific to the tumor-specific form of MUC-1.” The study included seven DCIS samples, and the test detected cancer in all seven, Mukherjee says, whereas they were all missed by CA-15-3.

This particular form of MUC-1 is found in about 90% of breast cancers, says Mukherjee, although it is not found on some of the lobular forms, and it has been validated many times previously. “What is different about our technology is that it can differentiate the glycosylated form of MUC-1, which is not found in benign situations.”

Mukherjee hopes to first use the technology to develop a blood test for breast cancer recurrence, but the ultimate goal is to develop a test that can be used for women who have an abnormal mammogram; the test would be performed in lieu of additional expensive imaging studies and before performing biopsies. Nearly 80% of the breast biopsies performed today are benign, she points out, so it would be very helpful to have a blood test you could perform first that would determine whether or not the patient needed to have a biopsy. Looking further in the future, Mukherjee also envisions an application for the test in younger women who are at high risk for breast cancer and who could have this blood test instead of undergoing a mammogram.

The company is preparing to begin a follow-on study to further validate the test and is in late-stage negotiations with investors to raise money to support that work. According to co-founder and advisor Rahul Puri, CanDiag is working with angel investors and is also pursuing SBIR grants. In addition, the company was awarded $50,000 as the grand prize winner of the 2012 Charlotte Venture Challenge, a regional business plan competition.

Puri points out the technology has multiple applications, not only for diagnostic tests but also as an imaging and therapeutic tool, and it is not restricted to breast cancer, but also has potential applications in prostate, pancreas, esophagus, and possibly ovarian cancer as well.

Editor’s note: this article originally appeared in the June issue of Medtech Insight.