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Lumicell's website is http://lumicell.com/
This Q&A with Lumicell CEO Kelly Londy discusses new drug-device technologies in development for a range of cancers, beginning with breast cancer in the most advanced clinical studies.
Q: Among the many approaches to improving cancer outcomes, including surgical and therapeutic innovations, how are innovations at the initial point of surgery making an impact?
A: Removing as many of the cancerous cells as possible during surgery is one of the key factors influencing patients’ outcomes, but cancer cells are normally invisible to the naked eye. Applying novel technologies that offer new ways for surgeons to visualize cancer cells that have spread to tissues surrounding the tumor is a potentially high-impact way to improve outcomes for cancer patients.
Q: How can new technologies be applied to improve cancer surgeries?
A: To date, there have been numerous efforts to create contrast agents to illuminate cancer cells, or for detection devices to track them. These technologies have shown potential, but they have not been able to adequately identify cancer cells in the margin – the outer edge of the tissue surrounding the tumor. The latest innovation, however, integrates a drug contrast agent, handheld imaging device with exquisite single-cell detection capability, and advanced software. Used together, these components of the Lumicell System give surgeons a “tri-pack” of tools that provide greater certainty when identifying and removing cancer cells in the margins.
Q: What is the data supporting the use of new drug-device systems in cancer surgeries?
A: Indeed, it’s critical for a new technology to demonstrate that it provides reliable results for detecting cancer in surgeries. For example, the most recent Phase 2 data presented at the 2017 San Antonio Breast Cancer Symposium showed that the Lumicell System was 100% accurate in detecting residual cancer in the tumor margin during lumpectomy surgery. The system also detected all breast cancer sub-types including invasive ductal cancer, invasive lobular cancer, and ductal carcinoma – showing the robustness of the system.
Q: Why are repeat cancer surgeries a common problem?
A: While surgeons can use multiple imaging tools to detect a tumor mass, determining the tumor margin is much more difficult because tumor cells are sparsely distributed among healthy tissue. Removing all of the cancer with the first surgery, while preserving healthy tissue, is a key goal for surgeons, but is not easy or reliably achievable.
Q: How many people require multiple surgeries to achieve clean margins?
A: That depends on the type of cancer. In breast cancer, procedures to remove the tumor and nearby tissue (i.e. lumpectomies), for example, are one of the most common cancer surgeries. The majority of women with early-stage breast cancer undergo such surgery, resulting in about 300,000 lumpectomies per year in the US alone. An estimated 1 out of 5 women who undergo a lumpectomy must endure a second, third, or even fourth surgery if cancer cells are left behind from an earlier surgery.
Q: How does a new system that combines drug, device, and software work?
A: What’s significant and unique about our most advanced system with drug, device, and decision software is that it integrates all the technology elements to create an ultra-sensitive and intra-operative system that provides the surgeon real-time, visual feedback of residual cancer. The proprietary contrast agent lights up the cancer cells, the Lumicell hand-held imaging device captures that signal, and then the decision software gives the surgeon real-time data that he or she needs to see what has been left behind within the surgical cavity, not just the shavings that have been taken out, and proceed with the surgery while it is still in process.
Q: Does the adoption of new drug-device approaches change the typical cancer surgery workflow or process?
A: The surgeon can use a drug-device technology in the normal workflow as he or she performs the procedure. The pathologist will still confirm that the margins are clear, but overall the process is designed to be efficient for surgeons and enable the patient to undergo a single surgery.
Q: Will new technologies impact the cost of cancer surgeries?
A: The cost of repeat surgeries is obviously quite high, and it is estimated that 40% of patients who undergo lumpectomies, for example, end up back in the OR for another resection. But the biggest reward will be giving patients the relief of knowing all the detectable cancer has been removed and that they are very unlikely to need a repeat procedure.
Kelly Londy is CEO and a member of the Board of Directors of Lumicell.