ViveBio Enabling Ambient Temperature Storage of All Liquid Samples

Imagine completely eliminating the need for cold storage of samples. Imagine the dramatic reductions in transport costs with no sacrifice of the integrity of biological molecules in the specimen. ViveBio (Atlanta, Ga.) has a strategy to revolutionize the way sample transport and logistics systems are managed.

DTET recently spoke to Timothy Murray, ViveBio’s president, about the advantages afforded by the company’s dried sample transport and storage technologies, as well as the company’s impending launch of its first laboratory developed test (LDT).

How do the ViveST and the Vive Plasma Separation Card (PSC) technologies improve sample collection and transport?
ViveST and VivePSC have applications both within molecular and outside of molecular testing. We are very excited. There is nothing like either of these products on the market. ViveST is generally used for high-volume sample transport and storage. It can accommodate up to 1.5 mL of liquid specimen—serum, plasma, urine, cerebrospinal fluid, you name it. It dries the specimen using our proprietary polymer chemistry and stabilizes the biological molecules in that specimen, whether it is DNA, RNA, or proteins.

The PSC takes the place of a plasma separation tube and utilizes a fingerstick or a heel prick. Using three to five drops of blood it separates the solid components—the white cells, the red cells, and platelets—and then captures the purified plasma on a small plasma collection pad. Separating and stabilizing the whole blood sample at the point of collection offers a lot of advantages for testing. With standard dried blood samples on a Whatman card, cellular debris and content spills out and you have a breakdown of red blood cells spilling their hemoglobin, which can inhibit polymerase chain reaction testing. With our technology, by separating out the cellular piece and just leaving pure plasma, you have none of that.

With both of these technologies, once the specimen is dried those samples can then be shipped under World Health Organization standards for dried specimens. You no longer have to ship it as a diagnostic liquid specimen. You no longer need dry ice, or wet ice, or special packaging. You can imagine the simplification for the user and the cost reduction for shipping and shipping supplies.

How do you see these products expanding testing access?
We feel in industrialized nations, the PSC is ideal for home health type self-collection. At a macro-level, you have consumerization of health care and decentralization of laboratory testing throughout the system. Many laboratories, big and small, are already doing self collection, especially in the area of molecular genetics. Take cheek swabs, for example. We see that need growing significantly over the next three to five years. With a product like the PSC you have a simple user interface similar to blood glucose meter. You just prick your finger and put three to five drops on the card and are done. It’s very simple. Just a few of the types of tests that can be done this way are non-invasive prenatal testing, which is performed using a plasma specimen, and any number of molecular virology tests like viral load and drug resistance testing for HIV.

The other area we are very excited is taking the ViveST membrane technology and embedding it into kits of in vitro diagnostics (IVD) manufacturers to stabilize the positive controls included in their kits. For example, imagine a point of care molecular test for an infectious disease target. That CLIA-waived kit will be in a physician office or a drug store and it will be in a non-refrigerated format on the shelf. Over the last year and a half, we have been working with the major control and calibrator manufacturers as well as several point-of-care, CLIA-waived platform developers for them to put their controls on our ViveST technology. These kits are in development and looking to go into clinical trials before the end of year.

Do you sell directly to laboratories? How much do these products list for?
With the ViveST and VivePSC we sell both direct and through distribution to clinical diagnostic labs, clinical researchers, contract research organizations, and one of our bigger customers is the U.S. Department of Defense because they are shipping specimens all over the world.

PSC in resource-limited settings has to be competitive with the Whatman card, or have a slight premium as a result of the technology embedded (i.e., $2 to $3). In industrialized markets, the PSC is roughly a $4 to $6 device. The ViveST has a current $5 to $8 per unit price, in line with a single nucleic acid extraction, a small premium over existing technology. Pre-analytic products are pretty price sensitive.

How do these products impact the workflow of the receiving laboratory?
We have found these products change how clinical laboratories do accessioning and processing once the specimen shows up. What happens is that the ViveST membrane is placed inside the barrel of 3 mL syringe. It is compressed and then you pull up a volume of buffer or first pre-analytic liquid and let it rehydrate 30 seconds before you are ready to run the test. With the PSC it is a bit more simple. Newborn screening labs process an enormous number of dried blood cards and they usually hand punch out a couple of punches. Our PSC is laser-perforated around the collection disc. The technician takes the tip of their pipette and pops it into the tube. We don’t sell an automated platform, yet. It is all done by hand, usually in a specialty-testing environment, not a super high-volume environment that would require automation, although we are looking at that for the future.

What impact does the dried sample handling have on the lab’s bottom line?
We have done quite a bit of analysis of FedEx and UPS charges. It differs by institution as to who cares about shipping costs. It is not across the board, but 50 percent of the time it is the lab manager or a financial manager. We can reduce shipping and logistics charges by 50 percent to 70 percent.

To stabilize and freeze to minus 20 degrees a small iPhone-sized cardboard pack with 500 μL in five tubes you need five to six pounds of dry ice and that is about $125 to $145 in an overnight FedEx pack. The same sized box with standard overnight on ViveST costs $25 to $30. It’s a big difference.

How do you see the pre-analytical sample collection market evolving over the next few years?
In the next three years, you will see both additional dry transport and wet transport technologies designed to stabilize specific types of biological molecules. It really started with Becton Dickinson and Qiagen with their joint venture for PAXgene Tubes. They created that segment by optimizing chemistry to stabilize RNA. I think you are going to see continued specialization of stabilization technologies. This dovetails with the decentralization and home health collection in the marketplace.

ViveBio recently announced it is entering the clinical testing market. What provoked the company’s entry into clinical diagnostics?
Strategically we knew we wanted to move upstream in the diagnostics value chain, up from the pre-analytics products, which have an average selling price $1 to $3 to $6, or $8, to diagnostic technology that can add more value to our company and to the health system. We were in a fortunate position to secure a great intellectual property (IP) portfolio that Renovar (Madison, Wisconsin) developed. We had been working with them and were able to come to terms for the worldwide exclusive license for all of their IP. Today that represents six patents and five patent applications. All the IP revolves around diagnostic methods and compositions for kidney disease and disorders.

We have had tremendous feedback from clinicians, nephrologists, and transplant surgeons because there is quite a bit of pent up demand for kidney transplant rejection technology. The standard of care today is a serum creatinine blood test, which is terribly non-specific and on the other end of the spectrum, the gold standard is an invasive biopsy. There is nothing in between. This technology fits a nice noninvasive niche, where we can monitor a patient using two key markers during the first year, when the majority of rejections occur, and tip off the clinician that something is going wrong, so they can take the appropriate therapeutic intervention. There have been a number of clinical trials and published articles validating the two key markers of the technology CXCL9 & CXCL10 and we are negotiating with a couple clinical labs to launch the test as an LDT within the next six months.

Is there an economic argument supporting the test?
We are spending a lot of time on the health economics of using these predictive biomarkers to guide treatment and monitor patients. Transplants are extremely expensive—more than $250,000 just for the transplant—and the federal government pays for the majority of transplants. We are engaged in a health economic study and believe this test could be a strong candidate for value-based pricing. It is pretty clear if we were to monitor all patients or a subset of patients, the cost of this is $X and could save $Y, if you can avoid a rejection. A rejection can be very expensive too and ultimately results in removal of the kidney, which is another couple hundred thousand dollars and then the patient is back on dialysis, which is also expensive. The numbers add up quickly and the value proposition for a diagnostic test in a monitoring capacity in year one is extremely attractive.