FAQ

Frequently Asked Questions

WHAT KIND OF SAMPLES CAN YOU TEST?

Anything in fluidic form can be tested, including human and animal samples, as well as agricultural and environmental samples. Some materials, such as soil, food and plants, may require grinding and liquefaction in order to be tested. Products involved in these processes are not supplied by 2PG, but are generally available from independent manufacturers, and can be used upstream of a 2PG test strip.

WHAT ABOUT SAMPLE PREP?

One of the benefits of the 2PG’s nanopore sensing is its ability to tolerate complex matrices that can interfere with traditional diagnostic testing systems. Tolerating background molecules drastically reduces the amount of sample prep needed, greatly simplifying workflow and reducing overall costs.

Some specimens can be tested without any prep at all, including saliva and other fluids typically collected by a cotton swab. Whole blood may or may not require prep, depending on the test.

2PG’s test strips are designed to mechanically support common processing steps, such as sample dilution, DNA extraction and amplification (PCR and isothermal) and concentration.

HOW MUCH SAMPLE VOLUME IS REQUIRED TO RUN A TEST?

The fluidic volume capacity of a test strip goes up to 100 microliters, which is adequate for many tests, including saliva, finger prick samples, and most other sources that can be swiped with a cotton swab. (Dry samples must be mixed with a transport buffer to deliver into the test strip.)

Many tests may require more volume, possibly due to the sample source (agriculture, environment), or because target abundance is low (cell free DNA, troponin, small molecule drugs, toxins).

When larger samples are collected, such as a venous blood draw or urine collection, the total volume must be reduced, with a possible concentration step – processes that are available in existing 3rd party products. After volumes are reduced, 2PG’s ShuttleCraft™ can further facilitate the transport of fluids directly into the test strips, greatly easing the workflow for end-users. (This may assist in obtaining a CLIA-waiver for those tests that assay developers intend to sell to consumers.)

CAN YOU PROCESS MULTIPLE SAMPLES (HIGH THROUGHPUT LABS)?

The 2PG MoM™ uses one test strip at a time, so only one sample at a time. But test strips can be incorporated into custom adaptors, such as hubs and larger scale systems. The video on the right illustrates a 5-strip test strip hub, which can be daisy-chained to support any number of strips. 2PG can partner with manufacturers who wish to create such devices using 2PG’s proprietary electronic components necessary for such operations.

WHAT TESTS ARE YOU MAKING, AND WHICH MARKETS ARE YOU TARGETING FIRST?

2PG does not make tests for our own platform, so we don’t target users, markets or industries. Instead, we provide an open systems development kit, where independent parties can make tests for a wide range of users and markets. Their relationship to 2PG is similar to software developers that make apps for smartphones: It’s their tests, so they are responsible for sales and marketing. (Sales revenues are shared with 2PG, similar to apps for smartphones. See the Partners page for more information.)

The 2PG MoM™, its test strips and ShuttleCraft™ sample delivery device are intended to work under robust environmental conditions, and easy enough for most anyone to operate the system. However, not all tests are designed for consumers, even if the workflow may be simple. This may be enforced by regulatory restrictions on a case-by-case basis.

WHO ARE YOUR PARTNERS, AND WHAT TESTS WILL BE AVAILABLE?

Most of the tests under development are from companies that already have tests made for traditional centralized labs across human and animal diagnostics, agriculture, environmental monitors, and government agencies. Many are adapting their existing portfolio of diagnostic tests to work on 2PG’s hand-held platform, while others are creating new tests from scratch. 2PG does not announce the availability of tests, except in collaboration with those partners who wish to publicize their activities.

WHEN WILL 2PG DEVICES BE AVAILABLE?

2PG has not announced when commercial products will be available, nor is it yet seeking distributors.

Those who enter into 2PG’s partnership program will have early access to development kits in 2018. Until then, 2PG assists in developing tests on behalf of its partners.

WHAT ARE THE PRICES FOR DEVICES AND TEST?

2PG MoM™ devices have not yet been priced, but since the components are similar to a smartphone, the MoM™ is expected to cost much less.

As for the cost of tests themselves, these are established by the developers, who can set their own prices for their own tests. Accordingly, prices will vary, but are likely to be governed by market demand and other pricing pressures (e.g., reimbursement from insurance companies, which is coordinated by the test developer, not 2PG).

2PG manufactures readers and test strips, which include the chemical reagents that perform those tests.

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, replacing their optics-based sensing. This would not only improve their own devices’ performance (better accuracy and sensitivity), but it would reduce cost (chips are less expensive than optics), and potentially ease workflow.

Modifying hardware may not always be an option, but those companies assays could still be used in 2PG’s MoM™, expanding their assay sales into new markets. Because 2PG does not make tests, these independent diagnostic companies don’t have to worry about competition from us for their assays.

HAS THE FDA APPROVED 2PG DEVICES?

2PG is not currently marketing or promoting its products for commercial use of any kind, whether regulated or not. Furthermore, since 2PG does not develop its own tests, it will not seek approval for those third party assays that may require FDA approval. When developers are ready to market products for commercial use, they will be responsible for obtaining clearance from the appropriate regulatory agencies, as may be required by law (FDA, USDA, EPA, or international agencies).

While the FDA has announced it will no longer require 510k certification for certain Class II devices, which 2PG intends for the MoM™, we will still be using ISO-certified manufacturing facilities and cGMP, as will be required for regulated tests.

Not all tests require regulatory clearance. Agricultural and environmental tests are common examples, and such tests could be sold directly to consumers. Whether a test requires regulatory clearance is the responsibility of the developer of a test, who assumes all liability for its performance and efficacy.

ARE YOUR DEVICES PRIVATE AND SECURE? WHAT ABOUT PERSONAL INFORMATION?

2PG devices are not smartphones. Users do not personalize them, and all tests are entirely anonymous. In fact, the 2PG MoM™ has no idea what test it’s performing–it merely reads molecules according to test instructions embedded in the test strip.

After a test completes, 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. (See the next section on “Apps.”) It is at that point that test results are known and associated with an individual person. It is the responsibility of that developer to comply with privacy regulations.

As for security, even though there is no useful information of any kind on a 2PG device, its operating system and data reside in an encrypted format at all times, including communications to external systems. Assay developers can indicate that a test only present success or failure information on the MoM™ screen, while the actual diagnostic results are transmitted off device, such as to a doctor, who can then decide if or how to communicate to the patient.

CAN APPS BE WRITTEN FOR THE MOM?

The MoM™ does not run local apps, as it is merely a dumb molecule meter. However, 2PG will provide an API for software developers to communicate with a MoM from a separate device, like a phone, tablet, computer, or remote cloud access point. Typically, those wrote develop the actual tests will also write apps for remote devices to interpret those results. 2PG has not announced availability for its software development kits.

HOW SENSITIVE ARE YOUR TESTS?

In combination with existing upstream sample prep methods, 2PG technology can achieve commercially available ELISA sensitivities in comparably less time. To further accelerate time to results, arrays of nanopore sensors can be incorporated into the physical device, and the test time can be extended to achieve lower limits of analyte detection. By combining a mix of proprietary buffer systems, sample preparations methods, and recording conditions, 2PG can rival the assay sensitivity and turnaround time of complex laboratory devices.

Summary of HGD65 Ab Detection and Quantitation Performance
Performance Criteria No Sample Background Spiked Saliva (10%) Spiked Serum (10%)
Detection Range 0.39-75 mg/liter 0.4-20 mg/liter 5.25-111 mg/liter
Quantitation Range 0.75-30 mg/liter 0.4-2 mg/liter 10-21 mg/liter
Precision CV=16% CV=32% CV=25%
Accuracy |PE|=12% |PE|=7% |PE|=10%

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.

For analyte tests, the efficiency of the binding molecule governs accuracy. False positives or negatives are strictly a function of the binding molecule efficiency, which is provided by the independent assay developer. Note that this illustration is but one of many ways to detect molecules. See the Analyte Dx page for more information.

Genomic tests (DNA/RNA) use primers and possible probes, also developed by third parties, and which are typically used in existing molecular tests today. See the Molecular Dx page for more information.

Fortunately, diagnostic companies have spent decades perfecting assays that yield highly accurate tests for use in reference labs today. And because the core biochemistries at the root of these reagents can be used in 2PG’s MoM™, the broad menu of highly accurate tests can come to market relatively quickly and inexpensively.

As a failsafe, any test that would require clearance by the FDA would need to meet minimum accuracy and sensitivity metrics, typically established by those predicate tests already approved and in use today.

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 testing 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. The Molecular Dx and Analyte Dx pages provide more information, and this concept is also illustrated in the videos page. To date, 2PG has multiplexed five genomic tests in a single chip, but the potential upper bound has not been fully explored.

Combining the two techniques – multiple chips and multiple tests within a chip – has the potential to multiplex a large number of tests at the same time from the same sample.

WHY IS THE COMPANY NAMED TWO PORE GUYS?

The company was originally named after the “two-pore” method of controlling the motion of DNA, as illustrated by this video. 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.)