White Papers

Companion Diagnostics

Pharma Industry Problems
Dramatically decreasing efficiency in bringing new molecular entities (NME; new drugs) to market along with rapidly increasing pharmaceutical R&D spending.

Many proprietary drug patents expire by 2015, totaling $150B in annual sales.

ApolloDx Solution
The ApolloDx diagnostic system, which is as easy to use as a glucometer, provides medical professionals with the ability to rapidly test patient drug, and biomarker levels.  In the future, patients may test themselves, and have test results automatically transmitted to their healthcare provider within minutes of the test being taken by the patient.  This ability enables the healthcare provider to precisely titrate the patient’s dose or biomarker status quickly.  Current Companion Diagnostics (CDx) requires the patient to be present for testing, with their results often available in 1-2 days.

ApolloDx’s companion diagnostic application can markedly improve

  1. The quality of the drugs pushed through the development process
  2. The speed to market of drugs
  3. Their effectiveness once commercialized

Thereby enhancing the pharmaceutical companies’ success and patient satisfaction by addressing serious medical conditions.

Multiplexing – A Better Way
Multiplexing enables the diagnostic testing device to lower healthcare costs by performing two or more tests per one consumable. Multiplexing becomes very powerful with the ApolloDx diagnostic technology particularly when testing more than one different analyte type such as, in pairs of analytes, a drug-gene or a drug-protein combination or, for a triple set of analytes, such as a drug-gene-protein combination.

ApolloDx’s platform can significantly impact diagnoses in multiple applications including:

  1. HIV testing
  2. Opioid testing
  3. Companion diagnostic testing

ApolloDx’s technology can test almost any analyte from as small as ions to as large as whole cells and all clinically important analytes intermediate in size using the same test strip.

Most/all other diagnostic systems are limited to testing one analyte type. Currently, blood is drawn from a patient into multiple tubes containing different anticoagulants and the blood in these tubes are further subdivided in the central lab for processing specific tests for different analytes. For ApolloDx’s platform, no dividing or subdividing is required.

Infectious Disease Surveillance

The Problem
The world was gripped with fear and uncertainty about the outbreak of Ebola in West Africa with an average death rate of 78%. An epidemiologist in Sierra Leone, from Doctors Without Borders, stated, “We are facing an epidemic of an extent that has never been seen before” regarding the widespread distribution of cases. On June 20, 2014, the senior official at Doctors Without Borders stated the surging spread of Ebola in West Africa was “totally out of control”. That was when there were 528 cases; by October 13th, there were over 8400 afflicted.

A recent first hand report from Sierra Leone was horrifying. Policemen were checking travelers’ temperature to determine whether or not they have a fever (from any cause).  If the person had a fever, they were immediately detained and placed into what is called an “Ebola Care Center”.  Also known as “Ebola Factories”.  Why are they called this?  Because people were held in tight quarters for at least four hours (if they are lucky) or for as long as more than four days waiting for the return of their Ebola test results. In summary, the prevailing testing paradigm was not solving the problem; indeed, despite best intentions, it was exacerbating it. Said differently, the highly touted PCR technology may be exquisitely sensitive, but it was impractical in rapidly halting the spread of the Ebola virus.

A missing key component from the public health organizations’ responses was being able to positively identify infected individuals, and isolate and treat them quickly before the infection spread further. Despite public health’s proclamations, the ‘window period’ between infection and clinical symptoms were not digital: people become increasingly infected after exposure and before clinical symptoms appear. The only way to decrease that window period for the essential public health benefit, was through point-of-need diagnostic testing before clinical symptoms appear.

ApolloDx’s Solution

  • Rapid testing capabilities
  • Integrated, real-time tracking to deploy/re-deploy limited resources to the most highly afflicted areas
  • Rapid assay development capabilities
  • Access to a key biological substance needed to sensitize ApolloDx’s test to all 76 variants of the Ebola virus
  • Superior diagnostic system: inexpensive, thermally stable, easy to use ’system’
  • One degree of separation to leaders in most of the afflicted countries

Platform Validations

ApolloDx has completed external validations at multiple Universities. Details of the validations are held confidential and only shared under NDA. To request the white paper summarizing these validations please click the “request full white paper” link to the left.