Closely-held Contextual Genomics is giving oncologists a leg up to enhance cancer care with its new Find-It molecular test to detect genetic mutations in cancer patients.
“We deliver solutions through our lab partners that harness the clinical and genomic data of cancer patients to improve patient diagnosis and present expanded treatment options to oncologists and patients,” David Matthews, CFO, says in an interview with BioTuesdays.
Launched in 2016, the Find-It cancer panel is a multiplex, next-generation sequencing (NGS) genomic assay that screens for known gene mutations found in solid tumors, most of which can be treated with current targeted cancer therapies or drug candidates in Phase 3 clinical trials.
Mr. Matthews says that Find-It is designed for rapid deployment into partner labs around the world. The test evaluates the mutation status of tumor DNA at more than 120 well-characterized cancer genes, identifying optimal treatments for patients. “The Find-It test leads to personalized treatment for patients.”
Cancer is a genomic disease that evolves over time through mutations in otherwise normal cells. The detection of mutations across the genomes of cancer cells reveals targeted treatment options for patients for which they would otherwise be ineligible.
While some 50 new-targeted cancer drugs can only be administered to patients on the basis of knowing the status of specific gene mutations in the patient’s tumor tissue, he points out that there are some 470 targeted cancer drugs in clinical testing that require mutation testing.
“Our test will also tell physicians if there is a clinical trial underway with their patient’s specific mutation and aid drug companies with pre-enrolment of patients to exclude potential non-responders to their drug,” Mr. Matthews contends.
Mr. Matthews says Contextual’s approach to cancer care is inherently data intensive. “Data driven medicine is part of a transformative paradigm resulting in ultra-high volume datasets that are driving new biomedical discoveries and informing and enabling precision medical care,” he adds.
“We develop and deploy next-generation sequencing (NGS) tests to detect mutations in cancer DNA, then combine these results with clinical data,” he says. “This results in high volume datasets, which are analyzed and interpreted in relation to a patient’s clinical care.”
In addition, he says NGS has the potential to track the evolution of cancer under treatment and provide the data necessary to predict if patients are relapsing while on a given therapy, which allows oncologists to change treatment regimens early in disease management, leading to improved outcomes.
While NGS costs are now affordable, he points out that the analysis of the data requires a heavy investment in software development and bioinformatics, which is only available at top tier cancer centers or privately as a premium price medical test.
“Our product is an integrated molecular and computational process used by laboratories to generate, analyze and interpret NGS test data collected from cancer patients,” he adds.
“With our software-as-a-service platform, laboratories can, in a highly scalable manner, provide oncologists with quality-assured, comprehensive, clinically useful and individualized genomics-based knowledge for each cancer patient, including specific approved targeted therapies.”
Mr. Matthews says the company’s focus now is to push its products out into lab networks.
At the beginning of 2017, Australia's Sonic Healthcare (ASX:SHL), the industry’s third largest lab company after Labcorp and Quest Diagnostics, agreed to offer Contextual’s Find-It solid tumor test in Australia and then through its network of labs in eight countries.
Last week, Contextual teamed up with CORE Diagnostics of India to introduce Find-It in India under the name, geneCORE Hotspot. In a statement, Dr. Zoya Brar, CORE’s founder, said the test is a major diagnostic advancement that would allow doctors to treat each patient in a unique way by identifying mutations driving his or her disease. “This test has the potential to revolutionize cancer care,” she added.
Mr. Matthews says the company also is in talks to expand its distribution of Find-It with a lab group in South America.
“In our diagnostics business, we receive a royalty from our partner labs’ revenue, which varies depending on reimbursement country-by-country,” Mr. Matthews says. “We see an even greater revenue opportunity from offering our data collection services.”
The company also hopes to receive patient referral fees from pharma companies and contract research organizations related to clinical trials. And companies such as Pfizer, AstraZeneca and Sanofi have used Contextual’s products for cancer specific development programs. “We have ongoing discussions for new opportunities in pharma partnering,” he adds.
In 2018, Contextual plans to launch Follow-It, a blood-based “liquid biopsy” test to monitor the evolution of a patient’s cancer and how best to manage those patients with changing therapies. The test is performed two-to-four times a year.
Mr. Matthews says the current market size of the company’s existing sales pipeline with Find-It is about 15.6 million patients in North America, Europe, China, India and Australia. “With Follow-It, the revenue opportunity is significantly larger.”