What is the A-PON™ Plasma Separator?
The A-PON is a passive (self-driven) liquid plasma separation and collection device. It uses a proprietary technology, owned worldwide exclusively by GattaCo, which we call Cap-Reset™ Technology. Cap-Reset allow us to pull plasma (and any other liquid) through a purification membrane or filter, without the need to apply pressure. Once the filtration starts, standard capillary forces take over to continue the filtration and collection process. This new technology allows GattaCo to finally accomplish what others have been trying to achieve for over 30 years!
What does the name A-PON mean?
PON is an industry term meaning Point of Need, meaning anywhere “it” is needed. In our case the ‘it’ is unbound liquid plasma. There are already devices that can separate plasma from blood, but the plasma is retained in a membrane and cannot be easily retrieved for analysis. The ‘A’ designation was added because the A-PON was initially validated for the collection of antibodies in plasma, but it has since been shown to be useful for many other applications.
Does the A-PON have FDA approval?
Yes, the A-PON is registered with the FDA as a Class-I Medical Device, meaning it can be used for research applications (e.g. clinical trials) or diagnostic testing applications (e.g. antibody testing) once validated by a clinical lab that is using it for sample collection.
What can the plasma produced by the A-PON be used for?
Plasma produced by the A-PON can be used for any application that a lab or diagnostics company has validated it for.. Plasma from the A-PON can be dispensed into a sample collection tube and sent to a lab for analysis, or it can be dispensed directly into a diagnostic product for immediate test results.
Who can order the A-PON?
Diagnostic companies, clinical labs, CRO’s, university researchers and similar organizations can order the A-PON. We cannot sell the A-PON directly to consumers.
How long does it take to process an order?
If you are a new customer, once we receive your order we will contact you to confirm availability and qualify you as an approved customer. We will then send you an invoice for payment by credit card, bank transfer or other terms. Once qualified as a customer and payment is received the order should be shipped within 2 to 3 business days using the selected method (e.g. FedEx overnight or UPS ground, or other).
What are the shelf-life and storage requirement of the A-PON?
Real-time shelf-life is currently 6 months, but is expected to reach 12 months based on past study results. The A-PON only requires Room-Temperature storage conditions.
What are the storage and shipping conditions of the plasma produced by the A-PON?
Generally, biomarkers (the analyte to be measured or tested for by a lab, e.g. antibodies, viruses, hormones, etc.) are far better preserved in plasma than they are in whole blood, and whole blood cannot be frozen to extend this period. However, exactly how long they can be stored and under what condition depends on which biomarker they are. For example, antibodies may be stable for over a week at room temperature and can be shipped under normal shipping conditions, including experiencing high and low temperature extremes, whereas more sensitive biomarkers may only be stable at room temperature for 48 hours. This is one area that a partner lab must validate before adopting the A-PON, with our help of course. If it is found that the biomarker degrades more rapidly than is desired, then a simple solution is to add a preservative to the plasma collection tube that is used.
When will the individual A-PON and Lancet Pack be available?
We are putting together a kit containing the A-PON and a lancet pack, which contains accessories for finger-stick collection such as a sample collection tube, lancets, alcohol wipe, etc. An example image can be seen here. Samples are currently available for qualified partners. This kit will be available for sale in 2Q23.
What happens if not enough blood is added to the A-PON?
Full instructions for using the A-PON can be found here. If the A-PON is not filled to the indicated Fill-To line (75µL of blood) the device may either not function at all, or only a small amount of plasma will be collected. For proper performance, enough blood must be added to reach the red Fill-To line.
What sample collection tubes can be used with the A-PON?
Any sample collection tube validated by our diagnostic or lab partner can be used. Many potential tubes can be used based on downstream testing needs. Since the A-PON produces plasma, the sample and tube can also be frozen to preserve biomarkers over an extended period of time.
Can any lab analyze the plasma produced by the A-PON?
Liquid plasma is the preferred clinical sample type for the majority of diagnostic testing applications involving blood. Because of this, most labs are already set-up to process it. So, it should be easy to integrate A-PON plasma into any lab that is able to analyze small sample volumes. No additional specialized hardware is needed, such as what may be used for reconstituting dried blood samples.
Is GattaCo developing other products using similar technology as the A-PON?
GattaCo has an extensive pipeline of products planned for smaller or larger plasma volumes, collected by finger-stick, heel-stick, venipuncture, or other method. We are also working with companies to integrate our technology into their complete, sample to answer point of care diagnostic product. With GattaCo’s technology, many new accurate, sensitive and specific home testing products will become available so lab-quality blood testing can finally be moved out of labs, to anywhere they are needed (PON).
Will GattaCo ever sell directly to Consumers for self-testing applications?
GattaCo’s business model is to make our products and technology available to partner companies or labs. (B2B). We do not anticipate selling directly to consumers (B2C), but rather to make our products available to any company that is interested in partnering with us. Many of these partners may have a business model of directly selling to customers, such as for Telemedicine, Digital Health, Decentralized Clinical Trials, Direct to Consumer Testing, and other services.