NEUOME PEPTIDE SUCCESSFULLY LAUNCH TRUEHEART – A GAME CHANGER IN THE TROPONIN TEST SEGMENT FOR CARDIAC SYNDROME.
PROGRESS REPORT SINCE INCEPTION
1. Inception: Neuome Peptides Pte Ltd. was established with a vision of creating cutting-edge novel technology platforms integrating different scientific fields and using peptides as a background of the products. Our motto “Convergence of science” is manifested in each and every product that we build. Neuome Peptides Pte Ltd has four divisions namely Nanotechnology, Biology, Biomedical Electronics and IT-IOT divisions. This aspect of convergence of different scientific fields in creating novel integrative products differentiates us from rest of the competitors. Peptides are unique molecules with high flexibility of use in different aspects in healthcare from diagnostics, imaging to therapeutics. 2. Technology – Instadetect platform:
Our unique chemistry of using short peptides designed inhouse and patented are conjugated to vey small nanoparticles (less than 10nm in size) which when bind to specific biomarker, induce a color change to be detected by artificial intelligence enables electronic nearinfrared sensors. This technology called Instadetect platform which enables detection of levels of biomarkers from any biospecimen source. Each component of the Instadetect is described below:
2.1 Peptides: Peptides are short chain of amino acids (~12-15Kda) derived from proteins which interact. The interacting surfaces between two proteins are used to derive computational models and using structural analysis algorithms, specific amino acids which can detect a biomarker of interest are identified. This short chain of amino acids can be used for variety of purposes as mentioned earlier. Neuome Peptides created a patented novel computational algorithm to design these peptides. Creation of peptides which specifically bind to biomarkers enables high quality and low-cost diagnostics. In contrast, present day technologies which use antibodies that are bulky (~150Kda) and are not suitable for sensitive low abundant biomarkers. Our biology division consists of highly trained biologists and bioinformatics scientists who have successfully designed peptides for several uses.
2.2. Nanotechnology: Nanotechnology division at Neuome Peptides consists of senior scientists with decades of experience in developing novel nanoparticles for diagnostics and therapeutics usage. Nanoparticles are very important in several applications including diagnostics. Unlike many of the existing diagnostics technologies which use 70-100nm gold nanoparticles, our nanotechnology division created patentpending 5-10nm gold nanoparticles which are amenable for high quality diagnostics applications. By engineering small size nanoparticles, we create Instadetect platform. These small size gold nanoparticles are conjugated or bound to specific peptides designed as mentioned above which in native form are wine red in color and become purple once they bind to biomarker of interest. This color change and extent of color change gives the amount of the biomarker present in the specimen (saliva, blood or any other biological material). At Neuome Peptides, we design and develop electronic robos or machines suitable to detect the color change.
2.3. Electronics: Our electronics team consists of scientists who have successfully developed several biomedical products. We have devised and developed new electronic sensors containing robo which can detect the colorimetric changes of gold nanoparticles from red to purple while team consists of scientists who have successfully developed several biomedical products. We have devised and developed new electronic sensors containing robo which can detect the colorimetric changes of gold nanoparticles from red to purple while detecting very low amounts of biomarkers. Using 3D printing, several new designs of the robo are done and integrated with the electronic components.
2.4. IT-IOT: Our IT-IOT team consists
of senior programmers who design and develop artificial intelligence based computational algorithms for diagnostics kits along with mobile apps. Developing novel algorithms is dependent on the clinical studies which are conducted both invitro and clinical research based. The backend data generation using clinical specimens enables development of machine learning tools which then are integrated into the AI algorithms.
These algorithms give both qualitative and quantitative results on the spot. These aspects make us unique in developing next generation diagnostics technologies. 2.5. Clinical research and Regulatory
compliance: We have highly accomplished clinical research and regulatory compliance teams. The clinical research team has evolved collaborations with several local hospitals for running pre-validation research and validation studies. All the clinical research is carried out under the supervision of strict regulatory compliances starting from patient consent, data encryption, analytics and final results. All studies are approved by institutional ethics committees from collaborating hospitals and patient confidentiality is maintained. All the data records are anonymized and analyzed. In nutshell, Neuome Peptides Pte Ltd has established a world class infrastructure and manpower for all the requirements of novel products in the field of healthcare. 3. Product pipeline: Neuome Peptides, Instadetect platform is suitable for any disease and can truly enable point-of-care diagnostics. To start with we have To start with we have focused on ongoing pandemic COVID-19 and in our new initiative a new cardiac panel to detect acute coronary syndromes.
Following are the different products in pipeline at different stages of development:
3.1. Trucov-flow: This product is a ovel lateral flow rapid diagnostics of SARS-COV-2 virus using saliva within 3-5 minutes. The major advantages are that there are no saliva based COVID-19 diagnostics which are of RT-PCR standards as evaluated by Indian Council for Medical Research (ICMR). ICMR has approved and CDSCO has given the license to manufacture this product. Challenges of bringing this product into the market:
Regulatory: Further to ICMR-CDSCO approval, we wanted Hsa-singapore to evaluate our product to launch in Singapore. For past 6 months all communications with HSA and MOH have given confidence that they will evaluate our product however in our latest discussions have put several problems. HSA does not have a mechanism of evaluating the saliva based kits and want our kit to be modified for nasal and oropharyngeal swabs and use of viral transport medium for sample collection. In spite of making our kit for ease of use using saliva, these kind of constraints by regulatory authorities delay our product to be launched into the market. We have initiated entry into Philippines market and sales in Philippines should shortly begin, subject to local regulatory approvals which is pending.
Market: There is now a low incidence of COVID-19 infections in India and this reduces the market requirement in India. However, there is always a chance of recurrence of disease as was seen in the case of China. Hence, we have to be prepared with the manufacturing, sales and distribution plans to be in place. In addition, the ease of use of Trucovflow using saliva needs to be better marketed compared to the nasal and oropharyngeal swabs which are very uncomfortable to the patients. Cost advantages versus ease of performing the test must be showcased to the public at large. We are currently in discussions with TATA Medical & Diagnostics (TATA-MD) to have a marketing agreement with them to launch this product in various markets.
3.2. Trucov-breath and Saliva kits:
Unlike in the case of lateral flow, Breath and saliva kits are much faster and use a patient’s breath or a drop of saliva to detect SARS-COV-2 virus on the spot within 30-60 seconds. This technology uses latest electronics instrumentation to detect very low titers of SARS-COV-2 virus in a short time, and presently the AI based