Cost effective Customisation friendly RT Kit SMART RT COV19 Custom

To face the challenge of another COVID19 out break ; to stop the current spread & to stop the challenge of repositives- A Cost effective Customisation friendly Realtime Kit which work with any RNA Isolation/cDNA synthesis kit and any SybrGreen dye- COVID 19 Custom Testing Kit.

Dr. Beena P.S. holds a Ph.D in Biotechnology from CUSAT. Her expertise includes Genomics, Proteomics, Molecular Biology and Bioprocess technology with a total of 18 years of experience in project management, ICH GCP guidelines and biosafety measures. With a genuine interest moving forward with  OmicsGen LifeSciences  as Director, Promoter and with Chief Executive Officer role since Aug 2017.

Some patients, after ‘recovering’ from the Covid 19, could again test  positive by RT-PCR. The reason behind this positive test result may be recovered patients may still be virus carriers or they get a new infection, or a variant infection or any other reasons. Considering the lack of detailed information regarding these patients and the lack longitudinal studies, the management of discharged COVID-19 patients is crucial. But  a big threat remains behind this as we are unaware of the infectiousness of re-positive patients.  The recommended monitoring strategy for repositivity is monitoring the N gene in IgM-positive patients. This can ensure high sensitivity while reducing the time and cost. Here we are with a very sensitive, cost effective and simple Sybr Green test that cover  almost complete N gene with in 3 sets of primers. The test work with specificity and sensitivity of a molecular Real Time assay in a fraction of its cost. The assay is developed as  kits that can be customised with any Covid 19 RNA isolation kit, any cDNA synthesis kit,  Complete N gene construct is provided as positive control and a human specific housekeeping gene primers with or with out Sybr Green.

We are not aware on how many more outbreaks of this pandemic is expected, How can we meet the requirements at that time. Hence the first ladder we need to step up to face it is increase the number of testing a day until it reaches nil for a time period. To Increase number of tests  a day, Strategies  to be taken are  Less cost for the kit, Less processing time, Customisation of kit - so as to use any reagent  of any brand with any other component of other brand, Indigenisation of the kit and its components and more over solving repositive issues, variant capture issues etc. Hence this kit can bring in several such positive impacts to the current situation. If this comes to market, definitely it can bring in a control for further spread in a low cost, less complexity and accuracy.

We are not aware on how many more outbreaks of this pandemic is expected, How can we meet the requirements at that time. Hence the first ladder we need to step up to face it is increase the number of testing a day until it reaches nil for a time period. To Increase number of tests  a day, Strategies  to be taken are  Less cost for the kit, Less processing time, Customisation of kit - so as to use any reagent  of any brand with any other component of other brand, Indigenisation of the kit and its components and more over solving repositive issues, variant capture issues etc. Hence this kit can bring in several such positive impacts to the current situation. If this comes to market, definitely it can bring in a control for further spread in a low cost, less complexity and more accuracy.

We are not aware on how many more outbreaks of this pandemic is expected, How can we meet the requirements at that time. Hence the first ladder we need to step up to face it is increase the number of testing a day until it reaches nil for a time period. To Increase number of tests  a day, Strategies  to be taken are  Less cost for the kit, Less processing time, Customisation of kit - so as to use any reagent  of any brand with any other component of other brand, Indigenisation of the kit and its components and more over solving repositive issues, variant capture issues etc. Hence this kit can bring in several such positive impacts to the current situation. If this comes to market, definitely it can bring in a control for further spread in a low cost, less complexity and more accuracy.

Months

Milestones

3

Establishment of specificity and sensitivity with all available sybr green, cDNA synthesis kits and viral RNA kits

6

Establishment of specificity and sensitivity with all available  Real Time machines in market

9

Validation  by second party and  ICMR  Approval

12

CDSCO Approval

15

Product launch in the market

18

 Sales

The challenges associated to get the kit out to market are clearing the regulatory norms.  Being infectious and we don't have a BSL4 facility , need to address the beta testing through other facilities.  Our critical success factors are ICMR approval, test licence, CDSCO licence  and CE IVD registration. All these process has financial constrains also.

WE are working for universities like Kannur University, MG University, Cochin University etc.

Tninity challenge can help through with a funding immediately to come up with a right solution in right time.

NO Specific Idea