The embedded blood test is a key feature of KalibrateV. This blood test is being developed and will be performed by Wellspring Clinical Lab, Inc. (Wellspring which is affiliated with KalibrateV). Wellspring is engaged in unleashing the massive analytical power of mass spectrometry to perform inexpensive multiplexed blood testing. Its goal is to perform a wide spectrum of blood tests with clinical precision that are ultra-precise, ultra-convenient, and ultra-affordable. While we anticipate clinical precision will soon be achievable, vitamin testing precision is within current capability.
Mass spectrometry is among the most sophisticated forms of analytical chemistry. While testing blood is the most common application of analytical chemistry, mass spectrometry is rarely used for blood testing. Though powerful, detecting low abundance molecules in high complexity solutions is the Achilles heel of mass spectrometry. The high complexity and high dynamic range of blood has rendered mass spectrometry largely unsuitable for blood testing.
Wellspring’s patented isolation method (US8450465 and US9056895) unleashes the massive analytical power of mass spectrometry on blood testing. We liken it to finding needles in haystacks. Using affinity biochemistry, the target molecules are bound, isolated, purified, and concentrated. In this form, the target molecules are directly injected into mass spectrometers for robust, high-throughput, accurate, and inexpensive measurements.
Wellspring has been engaged in the research and development of its patented blood testing method for the last 10 years. A solid-phase isolation version of its blood testing method is currently in commercial use.
Wellspring has demonstrated and published proof-of-concept data for its liquid phase isolation in a peer reviewed scientific journal using an ultracentrifugation method¹. The target liquid phase isolation process for production will employ a field flow fractionation method. The engineering to embed the liquid phase isolation process into its blood testing method is underway and is expected to be completed during the 2nd or 3rd quarter of 2017.
The biochemical engineering required to develop the target analytes for KalibrateV’s product is expected to being in late 2016. The blood test for the launch phase of KalibrateV is expected to require about 6 to 8 months of biochemical engineering.
Wellspring will perform the blood testing for the KalibrateV product under a development and production contract that was entered into in early 2016. Under this contract, KalibrateV will pay fees to Wellspring for development, and then will pay fees to Wellspring to perform the production blood tests.
¹ Volk S, Schreiber TD, Eisen D, Wiese C, Planatscher H, Pynn CJ, Stoll D, Templin MF, Joos TO, Pötz O. Combining ultracentrifugation and peptide termini group-specific immunoprecipitation for multiplex plasma protein analysis. Mol Cell Proteomics. 2012 Jul;11(7):O111.015438. doi: 10.1074/mcp.O111.015438. Epub 2012 Apr 23.