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companion diagnostics

 
 

Companion diagnostics (CDx) provide information important to the safe and effective use of specific drugs or therapies. Current CDx requires patients to visit a testing facility and often, patients do not receive their results until days or weeks later.

rHEALTH® makes it possible for patients to perform self-testing anywhere, receive results in minutes, and have the information sent to their physicians automatically.

rHEALTH® is focused on replacing traditional modes of disease and therapeutic monitoring by providing patient-consumers and medical professionals with a more affordable as well as convenient alternative to manage their condition and therapies.

 
 
 

Devices are limited by FDA regulation for investigational and research purposes only.

Better Therapy Management with rHEALTH CDx

For patients, CDx can lead to faster access to promising new treatments and for their physicians, it means more confidence in those treatments. In particular, the rHEALTH® diagnostic platform can eases traditional burdens of CDx, reduce inefficiencies, and enhance patient-user convenience. 

 
 

Traditional CDx used to monitor treatments demand patients to regularly visit their physicians and testing facilities. Further delays may come from the samples being sent to central laboratory facilities and necessary administrative control protocols before physicians can finally receive a patient's results. This time-consuming process is not only costly for the patient and the healthcare system, but also prevents essential treatment decisionscrucial to guiding therapeutic decisions from being made quickly. 

rHEALTH® is different because we can directly give patients the necessary diagnostic and monitoring capabilities.

The progress we have made in adaptable consumable design empowers patient-consumers and physicians to perform laboratory tests such as multiplex assays and biomarker analysis in absence of the traditional laboratory facility.

Value Proposition Throughout the Product Life Cycle

Increase revenues with rHEALTH:

  • Offer a differentiated solution
  • Increase drug adoption
  • Increase patient retention

Therapies perfect for partnering with rHEALTH:

  • Compete with similar drugs
  • Require frequent laboratory monitoring
  • Require precise dosing
Value Proposition Timeline Graph_v1.PNG

CDx and Precision Medicine

Precision medicine is an evolving field in pharmaceutical and therapy developments. Advances in this field mean that patient-consumers can receive drugs or therapies regimens tailored specifically for their individual needs. 

CDx tests can be used to identify patient populations who would benefit from a given treatment and even who could be harmed by a treatment by determining the unique biomarker levels present in some but not all patient populations with a certain disease or condition. Before a drug enters clinical trails, CDx tests used to segment patients increase the chance that the participants will benefit from the prescribed treatment. This presents economic benefits for drug developers in the form of reduced costs and shortened time for approval. 

In a comparative example below, Xalkori, which was co-developed with a CDx, saved significant development cost and time.  It was about 50% cheaper and close to 4-times faster than comparable approvals.

Table: Comparison of development costs, patient enrollment and time for non-small-cell lung cancer drugs

 
 Source. Agarwal et. al,  The current and future state of companion diagnostics  

Source. Agarwal et. al, The current and future state of companion diagnostics 

 

Even late in a drug's life-cycle, CDx relabeling can enable a therapy to shift from being a non-primary line of treatment option for a general patient population to being the first-line therapy for a select group of patients.

Changing CDx with rHEALTH

Although the potential of CDx is undeniably exciting for the future of precision medicine, resource demands on the drug developers, patient-consumers, and healthcare providers present significant limitations. With these limitations in mind, we designed the rHEALTH® diagnostic platform with special attention to integrated usability in order to deliver gold-standard laboratory tests while removing traditional inefficiencies. 

rHEALTH® fundamentally changes the structure in delivery of diagnostics and monitoring care

Comparison of Central Laboratory Methods and the rHEALTH Platform

The average cost to develop and gain marketing approval or a new drug is $2.558 billion according to recent Tufts CSDD assessment. A substantial component are rising clinical trial costsdue to increasingly complex clinical procedures, as well as a corresponding increase in administrative and site-monitoring requirements.

Use of rHEALTH® for CDx development can increase efficiency and ensure continuity through during the process of CDx research and deployment. Particularly in the clinical stage, the integrated form of the rHEALTH® platform can streamline clinical trial procedures, get faster results using microvolume samples, and allow for better patient care.