Samples can come from virtually any source, but sample prep is required, which varies depending on the type of substance being tested, the volume size, and other factors.
WHAT KIND OF SAMPLES CAN YOU TEST AND HOW ARE SAMPLES PREPARED?
HOW MUCH SAMPLE VOLUME IS REQUIRED TO RUN A TEST?
2PG’s test strips currently accept approximately 3 microliters of fluid. A minimum concentration of the target molecule of interest must in that final fluidic volume. (See the section below on “sensitivity.”)
CAN YOU PROCESS MULTIPLE SAMPLES (HIGH THROUGHPUT LABS)?
Arrays of nanopore sensors can be incorporated into the platform to process multiple samples.
WHAT TESTS WILL BE AVAILABLE?
Most of the tests under development are from companies that already have tests in place across that target human and animal diagnostics, agriculture, environmental monitors, and government agencies.
WHO ARE YOUR PARTNERS?
We are currently partnering with Monsanto, Maxim, CITO Medical and UCSF. See our News page for more information.
2PG is not accepting new development partners at this time. We will make an announcement when the developer program opens up again. For additional information about partnerships, contact: firstname.lastname@example.org
WHEN WILL 2PG DEVICES BE AVAILABLE?
2PG has not announced when commercial products will be available, nor is it yet seeking distributors.
WHAT ARE THE PRICES FOR DEVICES AND TEST?
2PG devices have not yet been priced. Cost of the assays are established by development partners. Accordingly, prices will vary, but are likely to be governed by market demand and other pricing pressures.
WHO IS YOUR COMPETITION?
Rather than competing with other diagnostic companies, 2PG’s platform is open, allowing existing diagnostic companies to use 2PG’s silicon nanopores in their systems. Our nanopore technology replaces optics-based sensing, which improves performance (better accuracy and sensitivity) and reduces cost (chips are less expensive than optics).
HAS THE FDA APPROVED 2PG DEVICES?
2PG is not currently marketing or promoting its products for commercial use. Development partners will be responsible for obtaining clearance from the appropriate regulatory agencies. 2PG uses ISO-certified manufacturing facilities and cGMP.
ARE YOUR DEVICES PRIVATE AND SECURE? WHAT ABOUT PERSONAL INFORMATION?
It is the responsibility of our development partners to comply with privacy regulations. Note that after a test is complete, the raw data is transmitted through a secure connection to an external smart device, such as a phone, tablet, computer, cloud, electronic medical record, or other authorized systems, all of which lie outside the control of 2PG.
HOW SENSITIVE ARE YOUR TESTS? HOW ACCURATE ARE YOUR TESTS?
Accuracy and sensitivity are two different things. The ability to detect molecules in very low concentrations refers to sensitivity, but accuracy relies on the biochemistry of the assay to correctly bind to the targets of interest.
In combination with existing upstream sample prep methods, 2PG technology is as sensitive as commercially available ELISA tests in comparably less time. 2PG can rival the assay sensitivity and turnaround time of complex laboratory devices using optimal combinations of proprietary buffer systems, sample preparation methods, and recording conditions.
HOW LONG DO TESTS TAKE?
The time to results varies on the type of test. Analyte tests (proteins, antibodies, drugs, small molecules, etc.) typically require 10-60 seconds, whereas DNA/RNA tests may take up to 10-15 minutes if amplification is required. (Traditional thermocycling (PCR) takes the longest, while the newer Isothermal amplification can take a few minutes.) Additional time may be required for sample collection and prep.
DO YOU SUPPORT MULTIPLEXING?
There are two ways to test for multiple targets at the same time. The easiest way is to use different reagents across multiple nanopore sensors in a single test strip. This requires no additional development–it’s purely part of the manufacturing process. Since all chips in a strip operate independently and in parallel, multiplexing does not affect time to results. Furthermore, one can use analyte reagents in one chip, and molecular tests in another.
2PG has not determined the upper bound of chips that can reside in a strip.
The second way to detect multiple targets is to use chemical reagents that co-exist within a single chip.
WHY IS THE COMPANY NAMED TWO PORE GUYS?
The company was originally named after the “two-pore” method of controlling the motion of DNA. The founders, in their infinite wisdom and propensity for humor, called themselves the Two-Pore Guys. (Note, “guys” is defined as a group of people of either or both genders.)