Molecular Diagnosis and Prognosis of Carcinomas

Background:

Ductal carcinoma in situ (DCIS) is non-invasive type of breast cancer that occurs in the milk ducts, accounting for approximately 20% of new breast cancers.  DCIS is non-invasive and not life-threatening. However, patients diagnosed with DCIS have a higher-than-average risk (around 25%) of developing invasive breast cancer within 15 years. Unfortunately, there is at present no reliable method for determining the invasive potential of DCIS. Such an indicator would allow doctors to better identify and characterize DCIS lesions, to distinguish whether they are invasive or non-invasive, and assess the likelihood a non-invasive lesion will become invasive in the future.

Technology Overview:

This technology is a novel molecular marker that serves as an indicator of DCIS. The marker is detected in invasive carcinomas, but not in healthy breast tissue or in non-invasive breast tumors such as fibroadenomas. Critically, the marker can distinguish between DCIS of different grades, enabling doctors to assess the potential that a DCIS will develop into an invasive form. The marker requires small tissue samples and is minimally invasive to the patient. It will provide a highly useful tool in determining the prognosis of DCIS and related in situ carcinomas.

Advantages:

• Provides a sensitive and accurate tool for determining the likelihood that a DCIS lesion is (or will become) invasive.
• Minimally invasive to the patient.

Applications:

• Assessing prognosis of DCIS. This includes determining the grade of the DCIS, and the appropriate treatment option given the prognosis.
• Evaluating other related in situ carcinomas.

Intellectual Property Summary:

Issued patent: US7510832B2, “Molecular diagnosis and prognosis of carcinomas,” filed February 21, 2003; granted March 31, 2009 (https://patents.google.com/patent/US7510832B2/en).

Stage of Development

TRL 3 - Experimental proof of concept

Licensing Status:

This technology is available for licensing.

Licensing Potential:

This technology will be of interest to anyone involved in diagnosing and treating DCIS. This includes:

• Hospitals
• Private medical practices
• Diagnostic laboratories
• Research institutions