The products are blood based diagnostic tests processed using a combination of proteomic separation and Biosignatures’ unique analysis software technology. All the products listed here offer significant costs savings to payors, with BiopSave and BladderSafe also bringing major improvements to the patient experience, reducing the need for current more invasive practice.
- BiopSave - Used to tackle the major clinical issue of the large number of unnecessary biopsies used during the current diagnosis process for prostate cancer. Huge potential savings when used in this role, with the longer term goal of an immunoassay version to replace PSA. Net Savings potential: Over $600m p.a. in the USA.
- TigerPro – Identifies whether the patient has the aggressive form of prostate cancer or the indolent form. The combination of BiopSave and TigerPro address a $1bn market opportunity.
- BladderSafe - Replaces the current bladder cancer diagnostic processes. Net Savings potential: Over $23m p.a. in the USA.
- RenalCheck - Currently there is no test available for renal cancer. If large nodules are discovered (using ultrasound imaging) exploratory surgery is the only option. There are 58,000 new cases of renal cancer expected in the USA in 2010.
Delivery options
Current implementation uses the proteomic based system developed by Biosignatures (known as MPM). All cost savings estimates given assume that this is the implementation method. Low cost immunoassay versions of the tests are under development.
The Company has ensured that its products are designed to be used from day one to ensure that they meet real clinical needs. For example, the prostate cancer products are targeted at reducing the numbers of unnecessary biopsies (BiopSave) and distinguishing between the indolent and aggressive forms of the disease (TigerPro), while BladderSafe and RenalCheck, the bladder and renal cancer products were chosen for development because of the lack of blood tests for these diseases in current clinical practice.
Biosignatures is aware of the failure of many research projects to translate effectively from the laboratory into the clinic. The Company has therefore ensured that its products are designed to be used from day one to ensure that they meet real clinical needs.
For example, the prostate cancer products are targeted at reducing the numbers of unnecessary biopsies (BiopSave) and distinguishing between the indolent and aggressive forms of the disease (TigerPro), while BladderSafe and RenalCheck, the bladder and renal cancer products were chosen for development because of the lack of blood tests for these diseases in current clinical practice.
Biosignatures' ability to form close working relationships with clinicians enables the company to target product development even more accurately. For example, TigerPro is specifically targeted at patients with PSA between a range of 2 and 10 ng/ml as in current practice patients with a PSA > 10 ng/ml will go to biopsy irrespective of the results of other tests.
Using third party data generated by a US based Life Science company, Biosignatures analysed 234 neuro-degenerative samples (for Alzheimer's disease and Parkinson's disease) within two weeks. The results effectively generated tests with blind sensitivity and specificity of 90/90 and 90/80 respectively.