MIPS Project Detail:

Abilis Life Sciences Inc.

Bladder Cancer Diagnostic Signature Validation

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Company

Abilis Life Sciences Inc.

Potomac

Montgomery

County

, Maryland

Founded:

2017

Website:

Company Description:

Abilis LS is developing a non-invasive, accurate, sensitive and specific diagnostic staging test for bladder cancer. The company’s bladder cancer test has the potential to be quickly incorporated into the routine urinalysis of all adult male and female patients with hematuria, as well as for the surveillance of recurrence and progression in patients with a history of non-muscle, invasive bladder cancer (NMIBC).

MIPS Project

Bladder Cancer Diagnostic Signature Validation

Project #

6013.23

|

MIPS Round

63 |

Starting Date:

Feb 2019

MIPS Project Challenge:
The purpose of this MIPS project is to validate the Abilis bladder cancer test to determine its predictive value for both the detection of bladder cancer and risk- stratification of high versus low-grade disease.

Project Scope:
This MIPS project involves a preclinical study in a validation cohort of 200 patients with microscopic or gross hematuria. The validation cohort will be designed with a 1:1 ratio of bladder cancer patients and hematuria due to benign causes (infection, nephrolithiasis, BPH, etc). Sensitivity and specificity outcomes will be generated, as well as sub-analysis on the test to detect all urothelial carcinoma (UC), low-grade UC, high-grade UC, and the ability of the test to differentiate these diseases.

Results:

Bladder cancer is the fourth most common cancer in men and the ninth most common in women. Each year, more than one million people are found with symptoms associated with bladder cancer and almost 80,000 new cases of bladder cancer are diagnosed. The cost associated with the diagnosis and care of bladder cancer exceeds $5 billion per year in the United States. No single test is currently recommended for accurately ruling in/ruling out bladder cancer.

Abilis