Polish start-up offering unique test for diagnostics of endometriosis is looking for distributors

BOPL20230623009

The company has developed a test that enables quick and minimally invasive diagnosis of endometriosis. The test is already on offer on the Polish market.

The sample can be collected using a minimally invasive method during a visit to the gynecologist, and the patient can return to her normal duties.

The company is interested in expanding their business into foreign markets and establishing cooperation with distributors in Denmark, Netherlands, Sweden, Norway, Italy, Spain, Germany and Belgium.

Endometriosis is a prevalent (about 10% of the female population of childbearing age), hormonally dependent chronic disease of the female reproductive system associated with the presence of a foci of endometrial tissue (resembling the endometrium) outside the uterine cavity. The disease may be accompanied by symptoms, such as increased menstrual pain, pain during sexual intercourse, or chronic pain in the pelvic area.

The test developed by the company is an in vitro diagnostic real-time reverse transcription-PCR assay intended for quantification of the relative level of expression of the FUT4 mRNA, a marker of endometriosis in relation to the expression of GAPDH reference mRNA. Analysis is performed on RNA isolated from a biopsy taken from a patient's endometrium in the secretory phase of the menstrual cycle, in order to confirm or exclude endometriosis.

Sensitivity measures how often a test correctly generates a positive result for people with the condition being tested (also known as the “true positive” rate). The diagnostic sensitivity of the test was >94%.

Specificity measures a test’s ability to correctly generate a negative result for people who do not have the condition being tested (also known as the “true negative” rate). The diagnostic specificity of the test was >89%.

Product advantage:

• Fast diagnostic process - up to 48 hours from the moment of sample collection (depending on the laboratory occupancy) - today up to 8 years
• The PCR technique after the coronavirus epidemic is available in every city
• It is a medical device
• A quick diagnosis will allow the doctors to start treatment faster
• After taking the sample, the woman can return to her daily activities
• Other markers currently in use, such as CA 125 or Bcl6, are not specific for endometriosis

The company is looking for distributors and partners with experience in diagnostics business and gynecology division. The test is dedicated for professional personal use like diagnostic laboratories or hospitals.