Introducing OvaCis™

What Is OvaCis™?

OvaCis™ is a revolutionary Point-of-Care kit that is simple to use and enables physicians to distinguish benign from malignant ovarian cysts on-site, in the operating theatre.

Sample fluid from the ovarian cyst is taken from the patient and applied to the kit. Results are ready in just five minutes, and are 98% accurate.

INSTANT

The results are immediate, within five minutes. OvaCis™ is a rapid, colorimetric assay that can be performed on-site in the operating theatre, enabling the physician to make on-the-spot surgical decisions for the best outcome. In addition, OvaCis™ has ISO 13485 certification, making it the first intra-operative kit with 98% accuracy. It has now been patented for use internationally.

ACCURATE

OvaCis™ is the first test to use an intra-operative tumour marker to differentiate between benign and malignant ovarian lesions. It has a sensitivity greater than 98% and specificity greater than 92%, validated with laboratory studies on 529 archived cyst fluid samples. The Negative Predictive Value (NPV) of OvaCis™ is more than 98%, which means that a negative result will almost certainly be truly negative. In contrast, Frozen Section has high false negatives, because the sample section of the cyst wall that is analysed may show normal tissue, when in fact it is not.

SUPERIOR

OvaCis™ – developed by INEX Innovations Exchange and the National University of Singapore – has been three years in the making and utilises the latest medical technology available. It’s high-reliability and accuracy stems from the fact that OvaCis™ analyses cyst fluid, which is homogenous. It does not depend on the sample sent for biopsy, which may erroneously reflect a normal section of abnormal tissue.

How It Works

OvaCis™ is based on a proprietary Point-of-Care-Technology (POCT) platform.

The test identifies a protein biomarker found in ovarian cysts and the reagents combine to yield a colorimetric reaction to identify if the cancer present is benign or malignant.

OvaCis™ can be completed in three easy steps:

  1. Collect sample of cyst fluid during laparoscopic surgery
  2. Apply sample to the OvaCis™ kit
  3. Obtain results in just five minutes – Positive or Negative

The reagents combine to yield a colorimetric reaction to identify if the cancer is present as malignant or benign.

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Why OvaCis™

CA125 is the most commonly used tumour marker for ovarian cancer, but has limited sensitivity and low specificity1 in detecting early stage cancer. On the other hand, Frozen Section – the current mainstay of intra-operative diagnosis of Epithelial Ovarian Cancer – is limited in achieving an accurate diagnosis. It is also time consuming and not universally available, especially in developing countries.

OvaCis™, used in conjunction in laparoscopic ovarian cystectomies, can quickly identify malignant cancers with 98% accuracy. Physicians can then make critical decisions regarding the best treatment plan for their patient.

FAQ

What is OvaCis™ ?

OvaCis™ is a revolutionary Point-of-Care kit that is simple to use and enables surgeons to distinguish benign from malignant ovarian cysts – on-site in the operating theatre – in just five minutes.

What is an Epithelial Ovarian Cyst ?

An ovarian cyst is a sac filled with liquid that arises in an ovary. When a cyst is formed from the cells that cover the outer surface of the ovary, it is called an Epithelial Ovarian Cyst. More than 90% of ovarian tumours are classified as epithelial ovarian cancer. While most cases are usually benign, studies show that ovarian malignancy is encountered in 1 to 14% cases of laparoscopic cystectomies. Therefore, intra-operative testing for malignancy is vital for optimum surgical management, and particularly important for young women who wish to preserve their fertility.

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How does OvaCis™ work ?

OvaCis™ works by identifying a protein biomarker found in ovarian cysts. A sample of cyst fluid is taken from the patient during laparoscopic surgery and applied to the kit. The reagents combine to yield a colorimetric reaction which reveals if cancer is present (positive) or not (negative).

Who can administer the OvaCis™ test?

OvaCis™ is designed for healthcare professionals, which includes clinicians, doctors and nurses. A user information leaflet is enclosed in each kit, detailing step-by-step instructions on how to apply the cyst sample into the kit.

How useful is it in practical terms ?

Frozen section – the current mainstay of intra-operative diagnosis of Epithelial Ovarian Cancer – is limited in achieving an accurate diagnosis. It is dependent on the area of tissue sample being analysed, and may not accurately reflect sections of abnormal tissue.

It is also time consuming (approximately 30 minutes to 1 hour) and not universally available, especially in developing countries.

It is anticipated that OvaCis™ will revolutionise the practice of intra-operative surgical procedures. To date, no such kit exists, and it is envisaged that the test will routinely be used during ovarian cyst surgeries in the near future.

Where was the test developed ?

OvaCis™was developed by INEX Innovations Exchange and the National University of Singapore. It has been three years in the making, utilising the latest medical technology and Obstetrics & Gynaecology research available. OvaCis™ is now patented for use internationally.

When can OvaCis™ be used?

OvaCis™ is intended for the intra-operative detection of malignancy in women undergoing an ovarian cystectomy.

How accurate is the test ?

OvaCis™ is able to detect malignancy of epithelial ovarian tumours of all stages with a cystic component. Laboratory studies (using 96-well plate), display sensitivity greater than 98% and specificity greater than 92%.

References:
  1. Jacobs I, Oram D, Fairbanks J, Turner J, Frost C, Grudzinskas JG. A risk of malignancy index incorporating CA 125, ultrasound and menopausal status for the accurate preoperative diagnosis of ovarian cancer. Br J Obstet Gynaecol. 1990; 97:922-929.