NEW HAVEN, Conn.--(BUSINESS WIRE)--Data recently presented at the Society of Gynecology Oncology calling into question Mira Dx’s PreOvar® test is “so flawed that is surprising it was even considered for presentation,” says the top executive of Mira Dx.
Martin Verhoef, President and CEO of Mira DX, said the study presented by Dr. Andrew Berchuck “is puzzling because it makes claims based on inapposite data. This is really a classic case of comparing apples and oranges.”
PreOvar® is a test for the assessment of risk for ovarian cancer in specific female populations that are at increased risk for the disease. The PreOvar® test is based on measuring the presence or absence of a KRAS-variant which disrupts the binding of a specific micro RNA (let-7) to the KRAS gene. This marker was discovered in the laboratory of Prof. Frank Slack, Ph.D., a pioneer in the field of microRNA biology, in conjunction with Assoc. Prof. Joanne Weidhaas M.D., Ph.D.
The study is flawed because it draws its conclusions from data from a set of patients with little correlation to the patients which spawned PreOvar, says Verhoef.
“Specifically, the study tries to compare findings primarily from patients with sporadic ovarian cancer to the population on which the PreOvar test was based - strictly and carefully defined high risk patients from hereditary breast and ovarian cancer (HBOC) families,” said Verhoef. He added that many of the patients from the flawed study lack complete clinical information such as cancer subtype, family pedigrees or BRCA mutation status, while the PreOvar data is based on fully clinically characterized HBOC patients.
Instead of the KRAS-variant, Verhoef said the flawed study also “curiously” included data tracking a substitute marker using imputed data with a known error of at least 10%, which likely fundamentally skews the data, as well as population based control groups with unknown cancer status.
“We can only guess at the motivations of the group behind the study, but they have either ignored or are clearly not aware of the intended use of PreOvar,” Verhoef noted. “With seven peer reviewed publications presently out on the KRAS-variant -- some by our founders and many by independent groups -- and numerous manuscripts in press or submitted and out for review, there is no question of the importance of the KRAS-variant in cancer, and especially in women’s cancer.”
Verhoef said that in its continued efforts to further define the use of the KRAS-variant marker, in conjunction with major academic centers throughout the world Mira Dx is currently conducting numerous independent validation studies on patient populations appropriate for the validation of the PreOvar test.
“The first of these independent studies, which clearly confirms the original findings, has been completed and will soon be submitted for publication,” Verhoef said.
Ovarian cancer is one of the most feared cancers among women because symptoms are usually not present until the disease reaches advanced stages when it is virtually incurable. Some 22,000 women are diagnosed with the disease every year, while 15,000 women die per year of the disease, making it the 5th most deadliest cancer for women.
About Mira Dx
Mira Dx is a genomics company founded on research discovered at Yale University that is dedicated to the development and commercialization of novel microRNA-based tests for risk assessment and companion diagnostics. Our goal is to provide information that can help clinicians better understand cancer to better serve their patients, allowing earlier diagnosis, better management and ultimately higher cure rates. For more information, please visit www.MiraDx.com.