Products

OTraces plans to use its patented IP to drive multiple business opportunities. The algorithms and other techniques that comprise the software are embedded into a laboratory information management system wherein all patient and instrument data is stored in secure U.S. based servers. This software is the principal value-add for the company’s instrument systems now being developed for both breast and prostate screening, and access is now being offered to other companies through a unique cloud-based deployment program that could take higher predictive power around the globe.

Cloud-Based, Test Predictive Power

Enhancement Collaborations with Others

In partnership with Bio-IT Solutions, Inc. OTraces has developed a cloud-based system in which companies seeking higher accuracy send their raw biomarker data to OTraces’ servers for processing to raise performance levels, wherein OTraces would be paid either on either a fee-for-service or revenue-sharing basis. This is a highly interesting proposition because potential demand for this service is extensive, the business is highly scaleable, OTraces has strong potential pricing power as sole supplier, regulatory oversight in some cases should be limited, and associated processing costs for OTraces are nominal so profit margin potential should be very high. Specific provisions of the cloud-based system include the following:

  • On-demand service provision — The reach of the internet enables qualified partners to submit data and receive results wherever and whenever they want, without constraints of geography or time.
  • Scaleability — Ability to run many concurrent analyses; easy to increase capacity as needed based on customer demand, complexity of algorithms or size of data sets to be analyzed.
  • Product/Service Expansion — Straightforward to add new disease diagnoses, test methods, analytical techniques, data collection methods, reports and similar capabilities.
  • Consistent Service Delivery — Software, algorithms, training sets, reports, and related capabilities delivered consistently and reliably with full traceability.
  • Data Security and Access Control — The diagnostic platform will adopt the authentication, access control, data encryption and monitoring methods consistent with the best Internet applications that handle credit card information, patient medical records and similar private content.

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CANCER SCREENING, GLOBAL LAUNCH PLANS

OTraces is pursuing an opportunistic strategy to commercialize in sizable markets primarily outside the U.S. where regulatory conditions are favorable and value to the medical system and to lower healthcare costs can be readily demonstrated.

Canada and the U.S.

In the In Canada, a fast-track approval process is in place for technologies that can reduce national health costs and prostate cancer screening is a high priority. Management estimates the approval process in Canada could be completed in 12-18 months at a cost of less than $3 million. Market Acceptance in both the US and Canada are expected to be very rapid as the current test, PSA, is very poor.

Russian Federation

OTraces expects to launch its breast cancer screening test 2017 in the Russian Federation which has a breast cancer screening population of over 45 million that is poorly served by screening mammography, favorable proposed reimbursement, and market incentives that are expected to encourage rapid adoption of the OTraces test. OTraces investment in Russia to date has been nominal including high-profile clinical development by the Gertsen Institute, and product launch expenses will be subsidized by business partners.

CDx Instrument System

This highly automated testing instrument is manufactured to company specifications by Hamilton Company, producing an accurate diagnosis without human interpretation. Hamilton has been as strong supporter of OTraces, having provided all customization, programming and support at no cost, so that OTraces could transfer the immunoassay methods to the Hamilton high speed ELISA robot.

The CDx is designed to optimize the performance and predictive power of the OTraces’ cancer screening reagent test kits. The system allows completion of one full run of all 5 immunoassays in the test panel in one shift, with no operator intervention after initial setup. In production configuration, the system will complete 80 cancers scores per day. When OTraces reaches full population screening level, production throughput will need to increase to at least 300 cancer scores per day. The Hamilton group of systems in this category is scalable so increasing this important parameter can be done when needed.

The OTraces technology measures blood protein biomarkers at unusually low levels of concentration, and uses biomarkers that have deep functional connections to immune response which OTraces uses as a virtual stethoscope on early detection and the various aspects of the disease process. The process of converting this data into highly accurate test results is performed remotely, using algorithms and software centrally stored in U.S. based servers by Bio-IT Solutons, Inc. exclusively and on OTraces’ behalf.

Reagent Test Kits

Maxim Biomedical operates a large in Rockville, MD and manufactures and supplies reagents and test kits used in the CDx instrument. Maxim GMP and ISO 13485 certified production capabilities and supplies the OEM manufacturing needs for some of the industry’s largest global companies.

BC Sera Dx Test Kit

BC Sera Dx Immunoassay test panel for detection of the presence of breast cancer in women.

PR Sera Dx Test Kit

PR Sera Dx Immunoassay test panel for detection of the presence of prostate cancer and discrimination of benign prostate hyperplasia (BPH) and aggressive from non aggressive prostate cancer.

In the development pipeline are an Ovarian, OV Sera Dx, and Lung, LG Sera Dx, cancer detection test kits.

Laboratory Information Management System

While Roche, Abbott, and others embed clinical chemistry software into the instruments in the field, OTraces uses a high-capacity Laboratory Information Management System to collect all patient data in a central location for the entire installed base. The LIMS offers several advantages:

  • CDx Instruments will only run the company’s validated reagents.
  • Bar coded reagent packaging allows the instruments and LIMS to connect all factory QC test results, available in real time as the tests are run in the field.
  • All installed systems have a password-protected access to their own clinical site and confidentiality complies with HIPAA Standards and is fully encrypted.
  • Factory QC results are compared to field test runs lot by reagent lot.
  • Access to the software embedded in the LIMS is now being made available to others through a cloud-based capability operated by Bio-IT Solutions, Inc. wherein OTraces plans to participate either on a revenue-sharing or fee-for-service basis, with an expected growing list of companies across the globe.