DVx™ General FAQs

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1. What are the major differences between the DVx-03 and the DVx – 04?

The DVx – 04 is a new generation test device that adds additional functions to our previous generation of DVx. Some advanced features are:

—Analyzes a drop of material (2 µL) in addition to cuvettes (0.5mL)

—Provides results faster (less than 4 seconds) from a cloud-based analysis system

2.What types of testing/analysis does the DVx support?

The DVx-04 provides identity and concentration testing.

3. Can the DVx-04 be used for stability testing?

The DVx-04 is not a stability indicating method. It can be used for a one-time concentration test, but you should not be releasing products solely on this test. You should be conducting additional tests as well.

4. What level of user expertise is required to operate theDVx-04?

The DVx-04 is very easy to use. Almost anyone can operate the device. However, only a pharmacy technician, nurse, or a pharmacist should be running tests on the DVx-04.

5. What are the major advantages of the DVx – 04 over other spectrophotometers?

With the DVx -04:

—Both concentration and identity are provided

—Sample data is collected and aggregated over time – trending and analysis will improve with time and utilization

—DYNALABS does its own method development.

—The DVx-04 is backed up by the DYNALABS core lab facilities

6. What are the costs?

We will have an in-depth discussion with you about the type of testing program you would like to setup with DYNALABS for the DVx-04. Then we will provide you with a detailed proposal that will include the total cost of ownership plan for your testing program. In general, the fees include:

—Method development fees (8 methods are included for a one-time fixed price).

7. How can I become a DYNALABS DVx-04 customer?

Becoming a DYNALABS DVx-04 customer is a multi-step process involving a discussion and an onboarding and training process:

  1. Register with DYNALABS as a new customer.
  2. Go through the new customer screening process.
  3. Provide a list of drugs to be tested using the DVx-04, including formulas for each drug.
    • —DYNALABS will draft a proposal for your review and approval
    • —Once the proposal has been approved, DYNALABS will work with you to develop your own custom testing program and ensure you are trained on the DVx-04.