Canine TSH, Feline TSH and Feline total T4 added to Canine total T4
ANN ARBOR, Mich., May 20, 2020 (GLOBE NEWSWIRE) — Zomedica (NYSE American: ZOM), a veterinary diagnostic company, announced today that it has completed the final verification of three additional assays for use with its TRUFORMA™ point-of-care diagnostic platform. The newly verified assays, feline total T4 (“tT4”), and canine and feline TSH (thyroid stimulating hormone), together with the previously verified canine total tT4 assay, represent completion of the first two assays for both canine and feline of the total of five assays initially planned for use with the TRUFORMA™ platform.
The TRUFORMA™ diagnostic device, which is smaller than a desktop printer, has been designed to provide highly sensitive, species-optimized initial assays for the diagnosis of thyroid disease in dogs and cats, and adrenal disease in dogs. The Company believes that limited clinic staff training will be required to use the device to obtain and place blood samples and a small amount of serum (~100 μL) into a disposable assay cartridge which is preloaded with reagents.
Zomedica’s verification of its canine and feline TSH assays is noteworthy because to the Company’s knowledge a validated species-optimized TSH assay is not currently available for felines at either the point-of-care or at a reference lab. The currently available canine-optimized TSH predicate standard test has been evaluated for feline use, however that test is not able to distinguish between low and low-normal TSH levels in cats due to its limited sensitivity.1
The TRUFORMA™ TSH assay was developed and verified for use with both canine and feline samples. As part of research and development activities, 25 monoclonal antibodies pairs were screened to determine an antibody pair with optimum performance for canine and feline testing. Verification of the TRUFORMA™ TSH assay was conducted on-site at Qorvo Biotechnologies, LLC (“Qorvo”) in two different facilities on more than 100 samples across 700 cartridge runs using cartridges produced across numerous manufacturing lots. The time to result for the TRUFORMA™ TSH assay is less than 20 minutes.
Verification data demonstrated promising correlation and dynamic range results for the TRUFORMA™ TSH assay compared to the current industry standard Siemens IMMULITE® Canine TSH reference lab assay. If the same samples are tested on two different types of machines and achieve exactly the same results the correlation would be R=1. The TRUFORMA™ canine TSH assay showed high correlation (R = 0.99) to the Siemens IMMULITE® Canine TSH assay. 87 serum samples were run on the same freeze-thaw cycle on the TRUFORMA™ and Siemens IMMULITE® devices simultaneously to determine correlation results.
Dynamic range is the functional range of a test over which the concentrations of an analyte can be measured with acceptable accuracy and precision. The verification studies demonstrated a dynamic range allowing the quantification of both high and low TSH concentrations within the same assay for both species, which the Company believes is vital for accurate diagnosis of thyroid disease in canines and felines. The TRUFORMA™ dynamic range is 0.008-10 ng/mL (vs. Siemens IMMULITE® canine TSH dynamic range of 0.03-12 ng/mL) which the Company believes will permit the measurement of samples with very low TSH levels (feline hyperthyroidism) or very high TSH levels (canine hypothyroidism). Importantly, the lower limit of quantification for the feline assay enabled statistically significant (P value = 0.002) discrimination between normal and hyperthyroid feline serum samples.
The TRUFORMA™ tT4 assay (verified for canine use last month) has also now been verified for feline applications. The feline tT4 assay verification completed on the TRUFORMA™ platform, was conducted on-site at Qorvo in two different facilities. Verification data demonstrated promising correlation and dynamic range results for feline tT4 compared to the current industry standard Siemens IMMULITE® canine tT4 reference lab assay, which has been independently validated for feline use.2 The combined TRUFORMA™ canine and feline assay achieved high correlation of R = 0.94 to the Siemens IMMULITE® canine tT4 assay (P value < 0.0001). The combined TRUFORMA™ canine and feline dynamic range is 0.45 – >30 µg/dL which should permit the measurement of samples with very low tT4 levels (hypothyroid) and very high tT4 (hyperthyroid) levels.
The TRUFORMA™ platform uses Bulk Acoustic Wave (BAW) technology, developed by Qorvo, to provide a non-optical and fluorescence-free detection system for use at the point-of-care. BAW technology, also used in cell phones and the world’s most advanced radar and communications systems, is an extremely reliable and precise technology. However, Zomedica believes that the TRUFORMA™ platform represents the first use of BAW technology in disorder and disease-state diagnostics.
The Company’s verification studies are evaluating a total of three thyroid and adrenal assays intended for use with the TRUFORMA™ platform at commercial launch. The initial three thyroid assays are: canine and feline tT4 (thyroxine), canine free T4, and canine and feline TSH (thyroid stimulating hormone). Verification work is currently proceeding on canine free T4. The verification studies are also evaluating two adrenal assays: canine cortisol and canine eACTH (endogenous adrenocorticotropic hormone). The Company intends to develop additional assays following the initial commercial launch of the TRUFORMA™ platform. Upon completion of verification testing for the first five thyroid assays, the Company intends to commence the validation of each assay and to initiate a parallel pilot program focused on optimizing the customer experience. Assuming successful completion of this verification and development work, Zomedica intends to commence commercialization of all five initial assays in select strategic markets. As noted in the Company’s filings with the Securities and Exchange Commission, the expected timing for the completion of the development work and the commercial launch of the TRUFORMA™ platform and the five initial assays has been adversely affected by the coronavirus pandemic. Accordingly, the Company is currently unable to provide an estimate of that timing.
According to a recent report published in April 2020 the companion animal diagnostics market was valued at approximately $2.0 billion in 2019 and is projected to reach approximately $2.7 billion by 2027; a cumulative average growth rate of 4.1% from 2020 to 2027.3
According to a 2019-2020 American Pet Products Association National Pet Owners Survey 42.7 million U.S. households own at least one cat. In a paper from the Journal of Feline Medicine and Surgery it is estimated 10% of cats over the age of 10 will develop hyperthyroidism.4
Based in Ann Arbor, Michigan, Zomedica (NYSE American:ZOM) is a veterinary diagnostic company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Zomedica’s product portfolio will include novel diagnostics and innovative therapeutics that emphasize patient health and practice health. With a team that includes clinical veterinary professionals, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com.
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1. Peterson ME, Guterl JN, Nichols R, Rishniw M. Evaluation of Serum Thyroid-Stimulating Hormone Concentration as a Diagnostic Test for Hyperthyroidism in Cats. J Vet Intern Med. 2015;29(5):1327-1334
2. Singh AK, Jiang Y, White T, Spassova D. Validation of nonradioactive chemiluminescent immunoassay methods for the analysis of thyroxine and cortisol in blood samples obtained from dogs, cats and horses. J Vet Diagn Investig. 1997;9:261–8.
3. “Companion Animal Diagnostics Market Forecast to 2027 – COVID-19 Impact and Global Analysis by Technology; Application; Animal Type; End User; and Geography”, The Insight Partners
4. “The 2019-2020 APPA National Pet Owners Survey”, https://www.americanpetproducts.org/pubs_survey.asp
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