Forum Archive Index - April 2002

[Derek <dkw@paradise.net.nz>]

NZ has had some major problems in this area,
however there is a Aussie company that has the answers.
Polartechnics (PLT, http://www.polartechnics.com.au/ )
has developed a diagnostic instrument (Truscan) that takes
electrical readings and gives an answer immediately. Initial
trials have been very positive (way outperforms the pap smear),
a comprehensive trial is continuing.

PLT plan to release the product within the next 6 months
(starting in Italy). The market for such a product is huge and
  the market cap of PLT is still only about $110m AUD
(at $2.60 per share).

PLT will market the product in Europe, Australia, New Zealand
and the Philippines but is too a company small to handle the
rest of the world and this is being done by Ethicon who will pay
royalties to PLT.

PLT have been awarded the CE mark, allowing the product
to have marketed in Europe and have recently won an Australian
Design Award. Currently there are no competitors and Truscan
is fully protected by international patents.

PLT also have designed an instrument for determining if a spot
is a melanoma, this is still in trials and is performing well.
Many features of this device are also patent protected.

The shares are not heavily traded and should be regarded
as a longer term investment (in my book > 6 months).

Derek

(hold PLT (lots),  Needless to say - Buy at your own risk.)

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TruScan Cervical Cancer Screening Device

2.1. Product name
TruScan Cervical Screening System
2.2. Description
The TruScan system is designed to collect information directly from the 
cervix about the optical and electrical properties of cervical tissue using 
a pen like probe. A single use sensor, a plastic sheath that fits over the 
probe and used only once, ensures the process is safe and hygienic. A 
computer attached to the probe analyses the data and classifies the tissue 
as healthy, pre-cancerous or cancerous.

2.3. Principal function(s)
The TruScan system detects the presence of cancer and pre-cancer by 
measuring the tissues response to optical and electrical stimulation. The 
observations are compared to other tissue signatures that have been 
developed from thousands of colposcopic and biopsy evaluations. This tissue 
is then classified into normal and at risk groups and the results are 
provided on a printout. The multitude of measurements made by the device 
are processed, classified and fed to a intricate mathematical equation that 
arrives with the right diagnostic answer. The basic operation of the device 
is as follows:-
a) By using green, red and infra-red light sources, changes in tissue 
response are detected via fibre optic cables to the microelectronic hybrid.
The microelectronic hybrid detects the optical change and converts this 
information into electronic signals.
b) The processing unit then compares this electronic information through 
complex mathematical algorithms with a large historical database.
c) The output from the processing unit is the diagnostic result of the 
scanning device.

2.4. Brief as given by client to designer
The product has been evolving and developing over many years with extensive 
involvement from statisticians, clinical researchers, gynaecologists, 
engineers and specialists. No initial design brief for the product existed 
however numerous design requirement specifications for each design element 
of the product were created and are available if required.

2.5. Why does the product represent design excellence and why do you 
believe it deserves an Australian Design Award™?
The TruScan System will have the potential of reducing mortality rates from 
cervical cancer through higher accuracy and instant diagnosis compared with 
the conventional pap smear examination. The screening method does not 
disrupt the cervical tissue, because it only needs touch contact compared 
with the current process of abrading the patient’s cervix and removing 
cells for examination.
The device is a world first in the designed technology and application and 
represents many years of collaborative effort from a wide range of medical 
and microelectronic professionals, specialists and expertise. From a 
specific design aspect the product utilises unique bionic information 
transfer from living cells through electronic processing to diagnosis. The 
technology developed and embedded in the product is also innovative and new 
including the bionic processing of information, hybrid microelectronic 
interfacing with fibre optic light sources and sophisticated mathematical 
software algorithms.
For these reasons, we believe the product deserves to win an Australian 
Design Award in recognition of the design and development effort expended 
and the world market potential for the product.

2.6. Proof of success / market potential
CE mark being granted in response to meeting standards requirements as well 
as demonstrating clinical performance through independent clinical trials 
in Europe and Australia.

2.7. Do you have a patent or design registration for the product?
Polartechnics has a number of patents on the key areas of the product

2.8. Is the product currently being exported?
No, but is expected to have worldwide exposure and use.

2.9. Does the product replace goods which are currently being imported?
No there is no known competitor.

2.10. Product life cycle and environmental considerations
Product life cycle is expected to span a number of years.
Software - Electronics Design considerations

2.11. Are the procedures for developing the software-electronics 
documented? Are these available for review?
Will lead to a new paradigm for the way cervical screening is performed 
with increased accuracy, lower costs and instant results for the patient. 
For the first time cancer can be diagnosed through physical measurements of 
tissue properties.

2.12. Was formal quality control undertaken? Are these documents relating 
to this available for review?
The main simplication compared with the currently available pap smear is 
the reduced infrastructure required to perform cervical screening. The pap 
smear requires extensive infrastructure in terms of pathology labs 
specialising in cytology.

2.13. Was formal quality assurance undertaken? Are these documents relating 
to this available for review?
Yes and documents available

2.14. Is your organisation certified under ISO 9000 series and / or AS3563 
for the software component?
Yes ISO9001

2.15. For the software only, is your organisation certified under CMM 
and/or SPICE? If yes, at what level, when was the certification carried out 
and by whom?
N/A

2.16. How were the design requirements established and how was the product 
tested against those requirements? Are documents relating to this available 
for review?
Design requirement specifications were established for all aspects and 
elements designed and developed. Numerous documents exist to demonstrate 
design verification and validation.






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