With approvals in Europe and Israel for its CellDetect non-invasive test for recurrence of bladder cancer, Micromedic Technologies (TASE:MCTC) is seeking FDA approval for a pivotal trial expected to begin in the first quarter next year with bladder cancer patients.
“In parallel to the FDA process, we are looking to cooperate with CLIA labs in the U.S. to evaluate CellDetect in hopes of a potential partnership,” CEO, Guy Lerner, says in an interview with BioTuesdays.com.
Last November, Micromedic signed an accord with Axella Research, a contract research organization, to advance the 510(k) clinical and regulatory work required to commercialize CellDetect for bladder cancer in the U.S. Axella is financing the FDA process in exchange for royalties on future U.S. sales of CellDetect.
In addition to bladder cancer for global markets and an already developed test for cervical cancer, which is targeting emerging markets, Micromedic is developing its CellDetect platform as an assay for prostate cancer, as well as a unique genetic test for bisphosphonate-related osteonecrosis of the jaw (BRONJ).
“One of our major initiatives is to interact with potential partners to collaborate in the completion and commercialization of the BRONJ product,” Mr. Lerner says.
According to Mr. Lerner, there is a significant unmet medical need for cervical cancer testing in emerging markets. “Some 87% of annual deaths from cervical cancer occur in emerging markets where there is a lack of effective screening.”
Mr. Lerner, who moved into the executive suite of Micromedic in August, explains that the urine-based CellDetect technology enables an accurate diagnosis of cancerous cells based on a unique combination of color differentiation and morphology, utilizing a proprietary kit containing unique extract and dyes.
“Using a proprietary plant extract and generic dyes, CellDetect colors the nuclei of neoplastic cells in reddish-purple, while normal cells are counter-stained with green,” he adds. “CellDetect is the only histochemical staining platform allowing color discrimination alongside morphological examination for differentiation between normal and cancer cells.”
Early cancer diagnosis is critical for survival. Early diagnosis of prostate, cervical and bladder cancers can lead to five-year survival rates of nearly 100%, 91% and 96%, respectively, compared with survival rates of late diagnosis of 28%, 16% and 15%, respectively.
Micromedic obtained CE Mark in Europe for CellDetect after a blinded, multi-center clinical study in Israel that successfully identified cancerous cells in urine samples of patients with a history of bladder cancer. The study achieved its primary endpoint, with a sensitivity of 84.4%, which is significantly higher than other non-invasive tests, and specificity of 82.7%.
In addition, 30% of patients with a positive CellDetect and negative gold standard relapsed within 14 months, Mr. Lerner points out, explaining that where the gold standard found no cancer, CellDetect found cancer.
“We are just beginning our commercial launch of CellDetect in the UK, Spain, Italy, Germany and Eastern Europe,” he adds.
Bladder cancer is the fourth most prevalent cancer among males in the U.S. and the seventh most prevalent among males worldwide, with some 430,000 new cases a year. The rate of recurrence is the highest of all cancers, ranging from 50% to 80%.
According to U.S. clinical guidelines, patients with a history of urinary bladder cancer are required to undergo three-to-four tests a year to monitor disease recurrence in the first two years after treatment, and one-or-two tests annually thereafter. Because of high recurrence rates, the cost of diagnosing and treating the disease is among the highest of all cancers.
Mr. Lerner says the company’s goal is to move CellDetect from monitoring patients already diagnosed with bladder cancer to the diagnostic stage, where patients are screened for the first time.
“The monitoring stage, where CellDetect is being used now, is a market valued in the tens of millions of dollars a year, but as a diagnostic, this market is valued in the hundreds of millions of year,” he adds.
Mr. Lerner says Micromedic’s next product candidate is a CellDetect assay for prostate cancer, the most common cancer among men and the second leading cause of cancer deaths in the U.S.
“There is a real unmet need for an accurate diagnostic test for early detection of prostate cancer,” he says, because 30 million American men undergo PSA testing each year and about 75% of the biopsies performed after an elevated PSA test turn out to be negative.
In an earlier proof-of-concept study in Israel, CellDetect successfully identified malignant cells in urine specimens in each of the 18 prostate cancer patients. “These preliminary findings paved the way towards developing a urine-based assay for prostate cancer diagnosis,” he adds.
Micromedic is planning to start another study in Israel, which he says, will hopefully lead to a CellDetect Prostate assay to stratify patients with moderately elevated PSA, preventing unnecessary biopsied and saving costs in the health care system.
In cervical cancer, CellDetect has demonstrated higher sensitivity for detecting precancerous lesions than Pap staining. According to a study published in the peer-reviewed journal, Gynecologic Oncology, in 2014, CellDetect had a sensitivity of 90% to 95%, compared with Pap staining at 44% to 78%.
“One of our priorities is identifying potential partners in major emerging markets to commercialize CellDetect Cervical,” Mr. Lerner points out, noting that the market potential in India, China and Africa is about 600 million tests a year.
Micromedic also is seeking to partner its CellDetect Digital product. "Our staining technology is amenable to enhance digital pathology in order to distinguish between normal and cancer cells,” Mr. Lerner contends.
He says CellDetect Digital can be a powerful tool for image analysis by lessening the time to results, decreasing a pathologist’s workload, aiding remote pathology analysis and enabling digital archiving.
“We have performed a successful proof-of-concept study with CellDetect Digital and an off-the-shelf software package,” he points out.