NEW YORK (GenomeWeb) – Molecular diagnostic company Counsyl said today that it has launched an oncology business unit. Tom Schoenherr, Counsyl's chief commercial officer, will oversee commercial operations in both the oncology and women's health, while Brent Blake, Counsyl's vice president of oncology sales will lead the unit.
Kaylene Ready, director of inherited cancer at South San Francisco, California-based Counsyl, told GenomeWeb that the new unit will initially focus on inherited cancer, as the firm already offers a next-generation sequencing panel for this. Counsyl will also consider moving into somatic mutation testing and liquid biopsy, but does not yet have a timeline for such moves.
Ready also said the company has added 12 genes to its hereditary cancer panel, and plans to hire a sales force to market the test to oncologists.
Counsyl also plans to launch software called FirstCare designed to better identify individuals who would qualify for genetic testing based on their family history of cancer. Sutter Gould Medical Foundation is currently an early-access user.
"One issue in the oncology setting is identifying which patients need to be tested" for inherited cancer mutations, Ready said. For instance, she cited a study published online in Genetics in Medicine in 2014 that found that of 2,524 women at the Josephine Ford Cancer Center, only 9.5 percent of those deemed high-risk pursued genetic testing.
Counsyl itself has found that women who qualify for genetic testing for inherited cancer risk mutations often do not pursue such testing. When it offered its inherited cancer screening panel for free last year in San Francisco, about 46 percent of a subset of women who took the free test would have qualified for testing under the National Comprehensive Cancer Network's guidelines, and likely had testing reimbursed by insurance.
"The health system is really struggling with knowing which patients should be tested," Ready said, and it is that need that Counsyl believes its FirstCare software can address in order to drive sales of its cancer risk screening panel. Ready said that the company is looking at implementing the software in different settings, including in the oncology, primary care, and Ob/Gyn settings.
Patients take an online survey, which takes into account family history among other factors, and are classified as high-risk, elevated-risk, or average-risk based on the results. The software then lets the ordering physician know whether the patient is eligible for genetic testing or should be referred for genetic counseling. It also has an educational component that provides information to the patient on what the results mean and why the survey is being done. The online survey test requires a physician prescription and the results are sent to the ordering physician prior to the in-person patient visit, Ready said.
"The guidelines for hereditary cancer testing are complicated, and this software tool is designed to help facilitate that," she added.
Ready noted that Counsyl may enroll other clinics in the pilot program before launching the software commercially.
Although a growing number of companies now offer hereditary cancer testing, including Myriad Genetics, Quest Diagnostics, GeneDx, Color Genomics, and several commercial and academic medical centers, Ready said that the market is far from saturated.
"The perception may be that this market is crowded, but the fact that so many patients that qualify and would benefit from this testing are not getting it" shows that there is plenty of room. "There appears to be barriers out there," Ready said, which the company hopes to tackle at least in part with FirstCare.
Ready cited the company's online genetic counseling interface as another facet that would help set it apart from other companies.
Counsyl's oncology business unit launch comes just one month after it said it had laid off 27 employees in its sales support, marketing, design, and engineering divisions.
Counsyl CEO Ramji Srinivasan said at the time that the company was restructuring to focus on relationships with clinicians and medical providers. Ready reiterated that and said that the oncology business unit would contribute to that goal of "focusing less on consumer marketing" and more on clinicians.