Frequently Asked Questions

Describe the quality of the ingredients used in KalibrateV?

The vitamin supplement market promotes products on the vector of quality. In this context, quality refers to degrees of absorption—the proportion of the ingredients that are actually absorbed. The interest in absorption has to do with reducing the uncertainty of vitamin deficiencies; if the ingredients are being well absorbed, the likelihood of the vitamin deficiency diminishes.

KalibrateV plans to employ blood testing to assess the impact of vitamin supplementation on individual personal health. The degree to which vitamins are absorbed affects the blood test results. The vitamin dosage is adjusted accordingly to meet the absorption needs of each individual body.

Since vitamin dosages adjust for specific body absorption, we expect there will be less need to use expensive ingredients that are optimized for absorption. Using less costly ingredients, KalibrateV should be able to be sold at a price that is affordable for all.

 

How can KalibrateV expect to compete with large, established brands in a crowded, mature market?

Blue Ocean Book

We believe that KalibrateV is a “blue ocean” opportunity. Blue oceans, as defined by best-selling authors W. Chan Kim and Renee Mauborgne, are vast, uncontested market spaces where typical competitive factors are irrelevant. Blue ocean strategy is the pursuit of high levels of differentiation at the lowest possible cost. In contrast, competitors in “red oceans” compete head-to-head on common factors such as price or preferences, largely occupying the same space or “position” in consumers’ minds with little meaningful differentiation.

Competitive factors in the red ocean vitamin market include absorption efficiency, broad categorization, and price. Specifically, high absorption vitamins are made with ingredients the effectiveness of which is measured on the basis of absorption efficiency. Further, they are “personalized” according to age, gender, and body type. Finally, competitors tend to employ premium pricing strategies with the highest prices charged for vitamins with the highest projected absorption efficiency (as compared to low absorption vitamins, which have ingredients with lower absorption efficiency, are broken into even broader generic categories, and are sold at lower price points).

The promise of higher absorption merely helps sell products in a red ocean market because there is no closed feedback loop that allows consumers to validate supplement effectiveness. Consumers really have no way of measuring absorption efficiency other than to rely on brand promises based on broad categories, which hold only so much weight. Even GENELINK Biosciences that customizes vitamin supplements based on DNA, ignores current body and health status and dietary intake. In reality, absorption efficiency can be reduced to well below industry standards and make little difference because absorption efficiency is not inherently valued by consumers due to their lack of ability to measure its effectiveness.

In contrast, KalibrateV expects to operate in a blue ocean. KalibrateV’s blood test should provide customers with a closed feedback loop that allows them to assess personal body absorption rates and individual effectiveness, adjusting their supplement doses accordingly. Absorption efficiency is assumed. Many consumers may actually be able to take lower doses than they currently do. KalibrateV only needs to supply the ingredients necessary to meet each individual’s supplementary needs. This is high differentiation at potentially low cost.

 

Marketing research strongly indicates that individual personalization is highly valued by customers in the vitamin supplement market, making the speculative absorption efficiency rates currently employed by competitors largely irrelevant. We think individual personalization will place KalibrateV well above industry standards with regard to effectiveness. It also should make broad categories employed by other competitors in the vitamin supplement market—age, gender, lifestyle, etc.—largely irrelevant. KalibrateV is anticipated to take personalization to the highest level, taking into account and responding to each individual’s body chemistry and diet. By introducing a closed feedback loop to the vitamin supplement market, KalibrateV has the potential to become the most valued product on the market. KalibrateV’s closed feedback loop may even convince many non-users of vitamin supplements to become users of KalibrateV based on their belief that vitamin intake can be useful if measurable.

The strategic canvas for the vitamin market clearly shows the dramatically increased opportunity for Kalibratev’s blue ocean strategy versus the red ocean strategy currently employed in the vitamin supplement market based on speculative absorption, quality, and categorized effectiveness that fails to take individualized factors into account.

Tufts University School of Medicine researchers describe the Goldilocks Phenomena as  the Vitamin B9 dosing regimen that is not too much, not too little, but Just Right, where colon cancer risk, the second greatest cancer killer, is reduced[1].  Kalibratev uniquely provides Just Right dosing.

[1] J Mason, S Kim. Revisiting the Goldilocks Phenomenon: Folate and Colorectal Cancer Risk.   Nature – Am J Gastroenterol 2010;105:1914–1916.

 

 

Which blood tests does KalibrateV use to formulate vitamins?

KalibrateV will use blood test results, age, weight, race, and gender to customize its personalized vitamin formulations. The initial pilot product will utilize plasma vitamin D, along with age, weight, race, and gender. As the product matures, we expect the blood tests to expand to include plasma vitamin B1, plasma cystitis C, plasma vitamin B2, plasma vitamin B3, plasma vitamin B6, plasma vitamin B9, plasma vitamin B12, plasma coenzyme Q10, erythrocyte omega 3 fatty acid, erythrocyte total fatty acid, des gamma carboxy prothrombin, and HbA1c.  Over time, blood tests to monitor kidney and liver damage will be included.

 

Does KalbrateV use genetic testing?

KalibrateV does not employ genetic testing. Genes represent the design and blueprints of biological processes. Importantly, genes persist throughout life. As such, their usefulness for identifying deficiencies in nutrients like vitamins is limited because they are not affected by dietary intake or disease conditions. Vitamin supplementation is about curing dietary intake deficiencies. KalibrateV uses testing that represents the actual conditions created by dietary intake and disease conditions.

 

What vitamins does KalibrateV include?

KalibrateV tests for and includes vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, vitamin B1, vitamin B2, vitamin B3, vitamin B6, vitamin B9, and vitamin V12. There are blood deficiency indicators for most of these vitamins. For vitamins that lack blood deficiency indicators—vitamin A, vitamin C, vitamin E and vitamin K—dosage will be determined on the basis of age, weight, race and gender.

 

What is the manufacturing process used to personalize the vitamin dosages?

Multiple formulations of vitamin mixtures are produced in batches. Several hundred different formulations are anticipated being held in stock for selection. Algorithmic selection will be employed for picking the optimal vitamin formulation from the stocked vitamin formulations based on current blood test results, prior blood test results, and prior formulation, along with age, race, gender, and weight. This approach achieves a high level of personalization without the typically high cost of manufacturing that accompanies customization.

 

What is the projected price for KalibrateV?

The target price is set at $55 for a 3-month (90-day) supply. This price includes initial and ongoing blood tests for calibrating the vitamins.

 

Can KalibrateV monitor potential harmful effects of vitamin supplementation?

We plan to develop Kalibratev to monitor potential harmful effects of vitamin supplementation. The blood test will include analytes commonly used to monitor kidney and liver function that may be harmed by excessive vitamin supplementation. This information will be combined with dosing algorithms to reduce or eliminate supplements that may be damaging to internal organs.

 

What happens if the blood test turns out to be like Theranos’ blood tests?

Theranos has sought to disrupt clinical reference labs like Quest Diagnostics and LabCorp.  To disrupt clinical reference labs, it needed to launch with a competitive catalog of several hundred blood tests.  And it needed to demonstrate high clinical precision for the entire catalog.  This would be difficult for any company.  These are almost insurmountable barriers for a start-up company like Theranos.

Wellspring, the company providing KalibrateV’s embedded blood test, is developing novel methods to test blood for which it makes claims that have some similarity to Theranos’ claims although it achieves its outcomes using very different methods and technologies.  However, in order to meet Kalibratev’s requirements, Wellspring is not required to overcome these barriers that Theranos failed.  In the short term, it only needs to develop a few blood tests.  And, for KalibrateV, clinical precision is not required because these blood tests are not being used for clinical decision making – only to inform nutrition supplement dosing.

Further, Wellspring’s novel blood testing methods only need to meet KalibrateV’s minimum requirements of Vitamin D testing from a 100 micro-liter blood sample at sub-clinical precision.  In fact, for KalibrateV’s pilot demonstration, Wellspring will employ typical blood testing methods.  And, KalibrateV can launch its product with Wellspring’s blood testing performed with typical blood testing methods.  Thus, KalibrateV is not dependent on Wellspring’s novel blood testing method; but, KalibrateV’s product gets richer and better as Wellspring’s novel blood testing methods are perfected and adopted.

 

Wellspring makes claims about its blood test that seem similar to the widely-questioned claims made by Theranos. How does Wellspring’s blood testing method compare to that of Theranos?

Like Theranos, Wellspring claims to provide 1) ongoing blood testing 2) from small volumes of blood 3) at low cost. That is the full extent of the similarities between the two companies.

Wellspring’s objectives and methods are fundamentally different from those of Theranos. Whereas Theranos purports to provide blood testing primarily for the purpose of diagnosing disease, Wellspring’s objectives are to empower consumers to measure and manage personal health and dietary intake. While Theranos’ methods are not widely known, their patents suggest methods that employ analytical techniques not unlike those typically used in clinical labs but done in ways that are faster and more miniaturized. Wellspring, on the other hand, states that it achieves its objectives by unleashing the massive analytical power of mass spectrometry through a unique combination of techniques, many of which are reasonably well-known and some of which are novel to Wellspring. We believe Wellspring’s objectives and methods are realistic and grounded in existing research and practice.

Both Wellspring and Theranos claim to provide blood testing employing a finger-prick technique. Because Wellspring’s blood testing process is tolerant of sample contamination (due to isotopic internal standard quantitation) and protein denaturation (due to surrogate peptide quantitation), the blood draw can be done from home by the consumer using Wellspring’s unique smart-phone powered blood collection device. Theranos’ blood testing process is sensitive to contamination and denaturation of proteins, so it requires the fingerprick blood draw be performed by a technician trained in conventional blood drawing techniques to minimize contamination and denaturation of the blood sample.

 

Mass spectrometry is usually associated with high-complexity, high-cost blood testing. How does Wellspring make mass spectrometry affordable?

The dominant form of mass spectrometry used for clinical blood testing is the LC/MS/MS instrument. These are expensive instruments with liquid chromatographs (the LC of LC/MS/MS) bolted in front of them to simplify sample complexity. While very powerful and useful, these liquid chromatographs exact a high toll on throughput and robustness of the mass spectrometer. Without the liquid chromatograph bolted on, the mass spectrometer is robust with high throughput, which makes it affordable.

Wellspring unbolts the mass spectrometer from the liquid chromatograph. Wellspring is currently developing its novel form of sample isolation and concentration that will interface through direct injection. This can also be done by offline multiplexing the liquid chromatograph and using direct injection mass spectrometry. Until Wellspring’s novel form of sample isolation and concentration is adequately developed, it plans to use offline multiplexed liquid chromatography.

 

Wellspring expects to achieve clinical precision for its blood testing process. What is required to achieve clinical precision?

Clinical precision requires sufficiently low coefficients of variation (CV’s—somewhat analogous with margin of error) to support relevant clinical decisions. These vary from blood test to blood test. In general, <2% CV is a very high quality blood test, <5% CV is a good quality blood test, and <10% CV may be an acceptable quality blood test for many clinical purposes.

Wellspring’s blood test method is currently used commercially in pharmaceutical and biological research projects that do not require clinical precision. Clinical precision is expected to be achieved by 1) optimizing the protein digestion protocols, 2) implementing multiple peptide surrogate peptide quantitation instead of single peptide surrogate peptide quantitation, 3) implementing multiple isotope internal standard quantitation instead of single isotope internal standard quantitation, 4) implementing Wellspring’s novel form of sample isolation and concentration, and 5) replacing the currently used polyclonal antibodies with monoclonal antibodies.  With the ultra-low-cost behavior and the low volume sample requirements, additional precision can be engineered by employing a dilution cascade for reducing the dynamic measurement range and performing multiple replicates.

 

The embedded blood test creates demand for personal vitamin supplements.  Is this a conflict of interest?

Since the blood test creates demand for personal vitamin supplements, there is the potential for some degree of conflict of interest.  This creates the need for high credibility to be associated with the blood test so that the user can be confident that the data from the blood test is valid.  Kalibratev and Wellspring seek to enhance the blood test credibility by publishing data demonstrating the competency of the blood testing process, maintaining accreditation, seeking FDA approval for the blood tests and partnering with credible medical institutions for clinical studies based on the blood test results.