POC Medical Systems develops Pandora CDx for Screening of Breast Cancer
Q.1 POC Medical System’s new innovative technology ‘ MammoAlert™-Pandora CDx’, simplifies the process of screening breast cancer to a larger extent compared to the existing mammography test. Can you highlight the features?
A – The Pandora CDx developed by POC Medical Systems is a microfluidic platform for rapid, point-of-care serum screening. It is based on a unique, low cost disposable microfluidic disk. The platform is a very simple and easy-to-use system. This portable breast cancer screening test, which runs on Pandora CDx technology, uses a simple drop of blood to generate results in 15 minutes. It uses multiple cancer markers for high accuracy. The Pandora CDx has very high sensitivity and specificity which implies excellent accuracy and very low or almost nil false positive rate.
In simple words, POC Medical Systems has essentially developed a ‘lab in a box’, which looks like and functions like a CD/DVD player. It consists of three major modules as follows:
- A microfluidics disk where a reaction takes place between the blood and the reagents
- The chemistry which consists of various reagents already prepared and loaded on the disk so no human interaction is required in the field except for loading of blood
- The software which records and analyses the data and gives a report automatically post the test
So, the instrument which is called the Pandora CDx (runs on rechargeable batteries) can be taken to any village or in any neighbourhood or can be run in any lab or doctor’s office with minimal training.
The way it works is as follows:
- The lab technician or operator enters patient’s information on a tablet
- Pricks the patients finger with a lancet
- Applies the blood to the inlet in the disc where the blood has to be inserted
- Selects the test and presses ‘Enter’ on the machine ‘Pandora CDx’
- The test is then performed on its own and the results are displayed and printed within 15 minutes
- The disc is then removed from the Pandora CDx and disposed. Ten samples can be tested on one disc.
Difference Between Mammography (current gold standard diagnostic)&MammoAlert™
|Cumbersome, not easily accessible||Easily accessible, even in rural areas|
|Inconvenience; Awkward situations for women during Mammography||A simple prick on the finger and the blood test is done|
|Long test to result time||Test to result time is only 15 minutes|
|High cost||Low cost|
|High false positive rate||Low false positive rate, High sensitivity and specificity|
|Trained Personal required||No Doctor/ technician required. Even a simple health worker can conduct test.|
- MammoAlert™ technology is not competing with Mammography as it’s a screening technology, which will be able to screen the disease even before the signs &symptoms appear.
- Positive samples need to undergo mammography which will help in ascertaining the position of the tumour.
Q.2 Medical Devices and, new technology generally go through regulatory hurdles. Have you gone through the clearances of USFDA and the regulators in India, and how do the government perceive this technology?
A– In India, the regulatory path is quite simple for IVD devices as they are non- invasive devices and the Pandora CDx falls under this category. However, we have already acquired a CE certification from Europe.The CE Mark, is considered proof that a product has met the requirements of the harmonized European standard. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.
Q.3 – You have unveiled this concept early this year. Some information on the clinical trial front and other related studies and the response so far.
A –In addition to earlier conducted clinical studies in US, with the support of World renowned breast cancer expert Padmashree Dr.Raghuram Pillarisetti, we are conducting clinical validation studiesat following study centresacross India:
- KIMS Hospitals – Andhra Pradesh
- Amrita Institute of Medical Sciences and Research Centre – Kochi, Kerala
- Basvatarakam Indo American Cancer Hospital and Research Institute – Hyderabad
- HCG MULTI Specialty Hospital HCG Cancer Center – Ahmedabad
- Manipal Hospital – Bengaluru
- Maulana Azad Medical College University of Delhi & Associated LokNayak Hospital – New Delhi
- Tata Medical Center – Kolkata
Q.4 Will POC apart from owning this technology, also be directly operating the marketing activities?
A –We have started our India office in Mumbai at the beginning of 2017. This office is responsible for marketing activities in India market.
We are about to launch Pandora CDx technology in India in a couple of months’ time. Over the period this product will be made available to Africa, China, Europe and USA. The product has generated huge interest from all over the world. As a matter of fact, every day we receive emails from countries likeAfrica and Europe asking when the system will be available in their countries.
Q.5 Despite large number of women in India that includes even the educated class are prone to breast cancer, the tendency to get diagnosed is minimal. How do you plan to create an awareness and introduce your diagnostic system?
A –We are planning various public education activities to reach out to the masses. The activities like group activities, seminars, workshops willnot only be targeted at thewomen audience but also their husbands and sons, so that everyone is made aware of thegrave situation.
We will also take help of NGO’s and Government bodies to reach the masses. Generally, people do not have access to diagnostics in the rural areas because of cost and accessibility issues. The idea is to provide low-cost solutions to those, who need it the most.
We strive to change the way medical treatment is practised across the world, moving it away from symptom-based treatment to diagnostic/data-based treatments.We are confident of achieving our end goals i.e. ‘erasing fear of cancer’, as early detection means better cure rates.
6- Any new simplified technology for detecting other areas of cancer from the house of POC Medical?
A-As mentioned above, we are about to launch our test for breast cancer screening in couple of months’ time.However, going ahead, we expect to develop low cost tests for other cancers like prostate, ovarian, cervical, lung, liver etc.
Later we also planning to develop tests for cardiac diseases & infectious diseases. All these tests are expected to be low cost tests.