FAQ’s

vantix® DIAGNOSTICS Frequently Asked Questions

vantix® DIAGNOSTICS Philosophy on Point of Care

There is a growing global need for point of care diagnostics. More importantly the common belief that point of care diagnostics will increase healthcare efficiencies and improve patient care is gaining in acceptance. vantix® DIAGNOSTICS believes putting lab quality results in the hands of the physician at the time of the physician/patient visit will improve physician/patient interactions, increase ealthcare efficiencies and improve patient outcomes.

The emphasis of care is towards prevention and early detection of disease, as well as management of multiple chronic conditions. Point of Care testing puts real time results in the hands of physicians and patients which promotes more patient-centered approaches to healthcare. Studies show that the use of POC tests results in a reduction in morbidity and mortality and saves billions of healthcare dollars each year 1.

Product description – POC platform

The vantix® POC system is a diagnostic platform to be placed at the point of care that will provide  lab

quality results in real time to improve physician/patient interactions, increase healthcare efficiencies and improve patient outcomes. The vantix® system consists of three integrated  components:  an  instrument  the vantix® Reader, a single use test panel the vantix® Cartridge and a centralized  web-based  information  management  system the V-Lab™ web application. The enabling technology is a proprietary  and  patented biosensor  P3   Technology™.

The fully-automated diagnostic platform requires only a drop of blood applied directly to the credit card-sized vantix® cartridge.

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Regulatory Path and Timeline to Launch?

vantix® DIAGNOSTICS is seeking CE Mark and FDA approval. The company plans to launch the first panel (TSH/fT4) ex   US in the next twelve months and in the US (pending 510k clearance) in 2016, with four more panels planned over the next two  years.

How does vantix® intend to enter the market?

vantix® DIAGNOSTICS intends to enter the market through the physician’s office for the most routinely ordered blood tests for diagnosis and monitoring of chronic diseases. vantix® will then enter retail establishments with an extensive menu. In the ever evolving field of novel biomarkers for personalized medicine vantix® will provide an open POC platform for commercialization.

Who are the competitors?

The vantix® offering competes against the current infrastructure of reference laboratories. Physicians either send a patient to the reference lab for blood draws or do the blood draws in their office and then send the samples to the reference lab for processing. When the physician has the vantix® platform the patient will be able to get the most routinely ordered blood tests done at the physician’s office and have the results in less than 10 minutes. Since the sample is collected via a finger stick prick and the reader is designed for ease of use no specially trained operator is required to run the tests.

Does vantix® DIAGNOSTICS have any products available on the market today?

Currently vantix® sells a research tool that demonstrates the patented biosensor performance and capability. The vantix® Research Tool (VR2) is an open access 12 channel device that is applicable to many assay formats such  as

  • Nucleic Acid based assays
  • Enzyme assays
  • Ion-selective assays
  • Immunoassays

Working with commercial partners vantix® develops a variety of markers for human, food safety, veterinary and environmental applications.

  1. Market data from ESPICOM November 2009 Market Research Report; Titled: POC Diagnostics: players, products & future market prospects.
  2. Worldwide Market for In Vitro Diagnostic Tests, 8th Edition.

What makes the vantix® DIAGNOSTICS POC different than other POC diagnostics?

As the number of POC tests and devices continues to grow, it is inconceivable that potential users will have an interest to learn or use a large number of   devices.

Therefore considerable research has been ongoing for the past 10 years or so for a multipurpose POC platform that can run chemistries and immunoassays 2.

The market requires that a POC platform must support five key attributes:

  • Reference Lab Performance – POC tests return the same result as if it were done in a reference
  • Broad Test Menu – as stated above one platform that can run chemistries, immunoassays and
  • Ease of Use – does not require specially trained (CLIA waivable)
  • Complete Solution – provides for sample collection through Health Information Management Systems (HIMS)
  • Revenue Generating – provides the physician with the opportunity to collect the reimbursement for the blood tests.

To date no company has been able to bring such a product to market. We expect vantix® to achieve this goal.

Product performance?

Most recently seventy five (75) sera samples were   supplied by a large research hospital with known TSH values ranging from 0.02 mlU/L through 120 mlU/L.The samples included normal, elevated or suppressed   individual results. TSH assays were performed simultaneously on the vantix® platform. The vantix® TSH assay showed a 0.9851 R2 correlation to the results achieved by the hospital lab’s testing of the same samples. A list of applications and performance are available upon   request.

Test menu development schedule?

The initial focus is on chronic diseases with TSH/fT4 for thyroid function, Diabetes, Lipids, BMP (Basic Metabolic Panel) and CMP (Comprehensive Metabolic Panel) over the next 2 to 3 years. We are also working with biomarker partners that may impact this schedule.

Who are vantix® DIAGNOSTICS current customers?

Customers include a Fortune 100 consumer products company, government organizations, academic institutions and commercial partners.

Company description

vantix® DIAGNOSTICS INC. a privately held US company is focused on meeting the growing need for point of care diagnostics by providing physicians with a complete diagnostic solution from sample collection through medical records integration. This patented revolutionary  technology will provide lab quality results to physicians in real time resulting in enhanced physician/patient interactions,   increased healthcare efficiencies, and improved patient outcomes.  vantix®  is  well-positioned  to commercialize our technology for human point of care diagnostics as well as, biomarker development, environmental monitoring, food safety and veterinary diagnostics. Learn more at www.vantixdx.com.

Locations

US operations – located in the Boston, Massachusetts Bio-tech corridor and provide engineering, quality, regulatory,  marketing  and  corporate  administration.

How many employees does vantix®  DIAGNOSTICS have?

vantix® uses a flexible staffing model based on customer and development needs. Over the last 12 months vantix® has employed between 12 – 25 Fte’s.

The vantix® point of care system is in development and currently not available for sale.