NEW YORK (GenomeWeb News) – Health Discovery Corp. expects to receive a $250,000 payment from its partners on a prostate cancer diagnostic test by year's end and said it is ready to partner on several other tests.
In a letter to shareholders released yesterday, the Savannah, Ga., molecular diagnostics firm described the state of its business and outlined developments under way at the company, including progress with its MDx product portfolio.
In particular, the company cited its four-gene urine-based test for prostate cancer being co-developed with Health Discovery's commercialization partners on the test, Abbott Laboratories and Quest Diagnostics.
The deal by the three companies was inked last year. The test is currently in clinical trials and yesterday, Health Discovery said that it expects to become eligible for a $250,000 milestone payment from Abbott by year's end when Phases 1 and 2, as described in their FDA Submission Plan, are completed. Upon approval by US Food and Drug Administration, Abbott will pay Health Discovery royalties on a per test basis.
In addition, the company said that it expects to choose development and commercialization partners "in the very near future" for two other tests, a pancreatic MDx and a colon cancer MDx. Health Discovery is partnering with the Pancreas and Biliary Center for biomarker discovery work on both tests.
The company said that it is currently in discussions with "national clinical laboratories" to further develop the tests and then to commercialize them. It also has been talking with in vitro diagnostic firms on the colon cancer diagnostic.
The collaboration with the Pancreas and Biliary Center will allow it to complete the final validation work for the test, Health Discovery said, adding that earlier studies on the test have shown a sensitivity and specificity of 93 percent.
Lastly, the company said that it is ready to partner on its PAP Smear interpretation product. The initial development of the flow cytometry interpretation product has been completed and as a result, it will be looking for a national clinical laboratory for final development and commercialization.
The company added, "We believe that the image analysis techniques developed for the PAP Smear interpretation will allow the company to move quickly into developing products for the interpretation of other anatomic pathology and cytology specimens such as biopsies and surgical tissues."