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INTERview






Advance Dx’s revolutionary collection card, the “AdvanceDx100”, can Collect Whole Blood and Separate the Red Cells, enabling Laboratories to perform Micro Sample Testing


Ned Bedrio

Chief Executive Officer


Advance Dx Inc.

https://adx100.com/


Contact:

Ned Bedrio

847-677-3823

nbedrio@adx100.com


Interview conducted by:

Lynn Fosse, Senior Editor

CEOCFO Magazine


Published – October 25, 2021


CEOCFO: Mr. Bedrio, would you tell us about Advance Dx Inc., how long it has been around, how it came to be as a company and were you the founder?

Mr. Bedrio: Advance Dx (ADx) specializes in the manufacturing and development of methods used by laboratories to perform specific clinical laboratory tests on micro-samples of blood. Advance Dx’s collection card, the “AdvanceDx100”, can collect whole blood and separate the red cells, enabling laboratories to perform micro sample testing. The AdvanceDx100 is designed to safely collect a small sample without using a phlebotomist and in a non-clinical setting and send it to an approved laboratory where any one of several clinical tests can be performed.


ADx was founded in October of 2007. I am the founder, and the company was started when I was trying to come up with solutions to several problems I observed when I worked in a clinical laboratory:


1. Many clinical laboratory tests cannot be performed on common dried blood spot cards (like Whatman 903) as they are not able to separate the red cells which is required for many clinical laboratory tests.

2. The need to replace venous blood drawn in a clinical setting for certain clinical tests providing consumers, health care providers, pharmacists, and disease management professionals with an accurate, convenient, and cost-effective way to manage disease states and determine health condition

3. The ability to create an inexpensive blood transport device that can be sent via regular snail mail (USPS).


CEOCFO: Before we talk about your products, I see that you have a number of invention claims. Are you the inventor of your device and the associated parts or do you have a scientists or other investor types that work for you?

Mr. Bedrio: I have several scientists that work under my purview. One of the main scientists that is still a part of ADx today is Dr. Mark Pankow. He has developed many clinical and immunoassays processes and has been in the industry for several years. He is one of our inventors and developed the current blood card which has been improved over time.


CEOCFO: When were you issued the patent for your ADx 100, and would you tell us about the process and what that meant for you?

Mr. Bedrio: There are many patents for the Advance Dx, Inc. However, ADx 100 card was issued: U.S. Utility Patents # 8062608 and # 8252139. These were from the culmination of many years of work and knowledge spent in the clinical laboratory industry. 


We are very proud of the progress we have made as this field is becoming increasing popular as we move to at-home diagnostics testing, which we saw an explosive growth of during the pandemic. There are many new companies coming online trying to offer similar services, but we have had relationships with some of the top U.S. labs for many years. 

 

CEOCFO: Would you tell us about your ADx 100, blood collection cards used for laboratory reach and testing blood for clinical, medical diagnostic use?

Mr. Bedrio: The collection process is quick and easy only requiring an approved finger lancet, four drops of blood are taken from a nick of the finger, placed on our proprietary micro-sample collection card, and sent via USPS or overnight delivery to an approved laboratory for analysis.


Advance Dx’s proprietary micro-sample technology allows laboratories to perform multiple clinical laboratory tests using the ADx100 red cell separation process, requiring no need for centrifugation or refrigeration. Advance Dx’s protocols allow accurate laboratory tests to be performed using only a small amount of specimen. Tests can be performed by laboratories, health care providers, pharmaceuticals, research, corporate wellness, and disease management companies, thereby effectively replacing the need to have blood drawn from the arm for certain laboratory tests that are performed by laboratories using their equipment that they already have, eliminating the need to purchase costly new equipment.


Field collected micro-sample technology replaces the need to have venous blood drawn in a clinical setting for certain clinical tests providing consumers, health care providers, pharmacists, and disease management professionals with an accurate, convenient, and cost-effective way to manage disease states and determine health condition.


CEOCFO: What separates the ADx 100 from other products on the market? Why use the ADx 100?

Mr. Bedrio: The ADX100 card is one of the most well-tested and well-utilized dried blood spot cards to date. It has been validated by some of the largest laboratories in the United States under some of the most rigorous conditions. Our card has also been used in countries outside the U.S and has gained approval for CE Mark, Health Canada, and TGA for Australia.  


CEOCFO: Has anyone taken this approach to develop a blood collection card before?

Mr. Bedrio: Many companies have tried to compete with ADx but often underestimate cost as well as the testing needed to validate modern clinical laboratory assays. They also underestimate the scrutiny and testing their card will be put through for large labs such as Quest and LabCorp to approve their card for widespread use. 


CEOCFO: Are you currently working with the FDA to get approval for any particular use?

Mr. Bedrio: Yes, we are. 


CEOCFO: Would you tell us who manufactures your products? Are this done on partnership agreements or you purchase and they create and ship for a fee?

Mr. Bedrio: Advance Dx utilizes Aero-Med Medical (Cardinal Health Company), headquartered in Glastonbury, Connecticut to manufacture, store and fulfill the Advance Dx 100 blood collection card.


CEOCFO: Would you tell us about the market size, your current portion of the market and what you would need to do to see it grow?

Mr. Bedrio: The clinical laboratory market is a $25B market. Our portion at the present time is under 1%. 


CEOCFO: What is your geographic reach? Are you global?

Mr. Bedrio: We work in some of the fastest growing markets in the World…U.S., Canada, Europe, Middle East, and Brazil. Our goal over the next year is to enter the India market. 


CEOCFO: How do you currently reach the market? Do you attend trade shows? I see you have a website, is that an important aspect in reaching the market?

Mr. Bedrio: No, we do not attend trade shows, we provide product at no charge for scientific research for various entity and engage directly with either the clinical laboratories, Wellness companies, and direct purchase to direct to consumer businesses. 


CEOCFO: Where will future growth come from?

Mr. Bedrio: In the U.S. it will be driven by the explosion of direct-to-consumer testing solutions for clinical laboratories as well as the overall movement of Healthcare from the Health System to the home and community setting. 


CEOCFO: Has COVID caused an increase in business?

Mr. Bedrio: Yes, as it has intensified the need for blood sampling, handling and transport innovations that do not require phlebotomists, doctor’s offices or driving to your local clinic. For example, we have seen major growth in direct-to-consumer businesses. Their businesses have seen explosive growth over the last year. 


CEOCFO: In closing, why is Advance Dx an important company today?

Mr. Bedrio: ADx is well-positioned due to the ease in its technology. We have seen the growth of specific at-home tests over the last several years. The limitation has not been in developing the specific clinical assay but in how to properly collect a minimally invasive and adequate blood sample which is stable enough to be transported through the mail and will enable many laboratory tests to be performed. We have built this platform technology and the possibilities are endless. Our innovation can help drive a change in how healthcare is delivered.


Advance Dx Inc. | Ned Bedrio | Blood Collection Cards | Blood Spot Collection Card | Advance Dx’s revolutionary collection card, the “AdvanceDx100”, can Collect Whole Blood and Separate the Red Cells, enabling Laboratories to perform Micro Sample Testing | CEOCFO Interviews 2021 | Medical Companies | Blood collection, Advance Dx Inc. Press Releases, News

“ADx is well-positioned due to the ease in its technology. We have seen the growth of specific at-home tests over the last several years. The limitation has not been in developing the specific clinical assay but in how to properly collect a minimally invasive and adequate blood sample which is stable enough to be transported through the mail and will enable many laboratory tests to be performed. We have built this platform technology and the possibilities are endless. Our innovation can help drive a change in how healthcare is delivered.” Ned Bedrio

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