OVA1^® is the first blood test cleared to help a physician evaluate the probability that an ovarian adnexal mass is malignant or benign prior to a planned surgery.

When used in conjunction with a standard pre-surgical evaluation, OVA1:

• Helps assess the likelihood an ovarian adnexal mass is malignant prior to surgery
• Helps to identify patients for referral to gynecologic oncologists
• May lead to improved patient outcomes

Who May Benefit from OVA1?

OVA1 has been FDA-cleared for use in women meeting the following criteria:

• Are over 18 years of age
• Have an ovarian adnexal mass
• Have surgery planned
• Have not yet been referred to a gynecologic oncologist
• Have not had cancer in the past five years; and
• Have a rheumatoid factor concentraction <250 IU/mL

OVA1 is not intended to be a screening test or to determine whether a patient should proceed to surgery.

What are the benefits of OVA1 for physicians.

It is expected the availability of OVA1 will improve the management of women with an ovarian adnexal mass and improve clinical outcomes. More specifically, these benefits may include:

• More appropriate referrals of patients with high probability of malignancy to an expert
• Fewer second surgeries
• Fewer cases where a second surgeon unnecessarily participates in the surgical procedure
• More appropriate and efficient use of chemotherapy (e.g., IP port)
• Lower rate of recurrence and expense of treating advanced cancer
• Longer survival, associated with improved quality of life

Ob/Gyns may be particularly interested to know that OVA1 was able to identify women who did not have a malignancy with a high degree of accuracy, potentially enhancing the confidence of Ob/Gyns that a woman's condition did not necessitate referral to a gynecologic oncologist (NPV=93%, involving non-gynecologic oncologists).¹

¹ Data on File (from package insert, Vermillion Inc.)