Companion Diagnostics

Learn how JMLAB Pharma Services creates tests that can save lives.

First in industry

Our Pharma Services developed, validated, and submitted to the FDA the first companion diagnostic tests to receive approval under the HDE program. This work included establishing a design control program that enables JMLAB to meet 21 CFR part 820 regulations.

What if you could know in advance if a life-extending drug will work for you?

We often take medication without knowing whether or not it will work for us, and sometimes that’s okay because we have time to explore alternatives.

However, for many patients with rare forms of cancer such as mastocytosis or myelodysplastic syndromes, lifespan after diagnosis is measured in months. These patients need to know as quickly as possible whether or not a potentially life-prolonging treatment is likely to succeed.

A few years ago, JMLAB Pharma Services partnered with an international pharmaceutical company to create two FDA-approved diagnostic tests that help patients with mastocytosis and myelodysplastic syndromes find which medications work best for them. Using the molecular signatures hidden within patients’ DNA, these tests can determine whether Gleevec, a drug with the potential to treat certain types of cancer, is likely to be effective for a particular person.

In patients with myelodysplastic syndromes, the test looks for KIT D816V mutations because Gleevec is not efficacious for patients with this mutation. In patients with myelodysplastic syndromes, the test evaluates PDGFRB rearrangements which indicate that a patient is more likely to respond to Gleevec.

This type of personalized test, known as a companion diagnostic, is required by the FDA in certain situations and is just one example of how our team of experienced project managers embraces personalized medicine through providing precise diagnostics for our partner’s therapeutic programs leading to FDA approval of urgently-needed therapeutics. We also provide expert pathology insight to facilitate clinical trials for diseases with unmet need.

The impact of this testing on patients is enormous. Knowing whether or not a particular treatment is appropriate for a specific patient increases the probability of treatment success. It also helps prevent wasted time and resources, possible adverse side effects, and the negative emotional consequences of providing the wrong treatment.

The Pharma Services team is currently working on new companion diagnostic tests for rare diseases to determine patient eligibility for new therapeutic programs.


Companion Diagnostics
First in industry

JMLAB developed, validated and submitted to the FDA the first companion diagnostic tests to receive approval under the HDE program for rare diseases.

Why Partner with Us


Central Pathology Review
Experts in rare disease

JMLAB’s team of expert pathologists support our pharma partners’ new therapeutic programs by using their expertise to confirm diagnoses and tumor response.

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Academic Research
Born out of academics

JMLAB is a nonprofit enterprise of the University of Utah Department of Pathology. Our medical directors are faculty in the University of Utah’s Department of Pathology.

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