As the U.S. continues to battle the COVID-19 pandemic, we in the medical community must also keep our eye on progressing research and solutions in other disease areas with high unmet need. One of these is Lyme disease, which has similarities in symptoms with COVID-19, causing even more confusion in an already hard to diagnose – and often misdiagnosed – condition.

The onset of Lyme disease, which impacts an estimated 427,000 people each year, oftentimes signals the start of a long, frustrating and painful journey.  Lyme disease is frequently missed or misdiagnosed due to a combination of vague symptoms – fever, fatigue, muscle and joint aches – and unreliable testing at the beginning of infection.  In fact, only 30% of people acutely infected with Lyme disease test positive in the early stage when it is the optimal time to treat.

Since antibodies to an infection can take several weeks to develop, standard blood-based antibody tests fail to diagnose up to 60-70% of patients in the acute Lyme setting. These tests also cannot tell the difference between active and old infections, so many people will continue to test positive for the disease even after they have been successfully treated with antibiotics.  But the most unfortunate aspect of this paradigm is that if left untreated, Lyme disease can become a debilitating, chronic illness, leaving over 40 percent of sufferers unemployed and 27 percent on disability.

This complex, lengthy and costly journey of misdiagnosis or delay in treatment, or “diagnostic odyssey,” costs our healthcare system up to a billion dollars each year and may cause potentially life-altering and long-term complications for patients such as chronic pain and fatigue, memory issues and nerve paralysis. Along the way, patients are frequently misdiagnosed and treated for conditions such as multiple sclerosis and depression.

At Adaptive Biotechnologies, we believe that measuring the T-cell based response to Lyme disease can improve diagnosis, therefore enabling the right intervention and improving outcomes. Our immune medicine platform brings together science and technology such as AI and machine learning helping us to see how our bodies naturally detect and respond to many diseases, including Lyme disease. Similar to how we’ve responded to the call and need for better diagnostics to test for COVID-19 with our partner Microsoft, our goal is to develop a T-cell based diagnostic test for Lyme disease that is more sensitive in the earliest stages of disease – so patients can benefit from more accurate diagnosis and treatment when it is most effective.

An important priority at Adaptive is the launch of the ImmuneSense Lyme clinical validation study. Preliminary data on our immunoSEQ Dx Lyme Assay test shows the test could be significantly more sensitive than standard serology testing in the early stage of disease. In this new study, we hope to confirm these findings and have the opportunity to bring forth a new diagnostic for this serious and often overlooked condition. It’s time to improve the diagnostic odyssey for those impacted by Lyme disease, and we hope to help bring about this change.

I’ve known far too many people who have received a cancer diagnosis, navigated the initial shock, and bravely taken on all of the ‘stuff’ that comes with it – finding the right clinician, deciding on a treatment plan, and readjusting their life to the unknown.

What if my treatment stops working? What happens if my cancer returns? How long will I stay in remission?

Treatment for blood cancers has evolved rapidly, and the measure of minimal residual disease, or MRD, is becoming an increasingly important measure of the presence of cancer throughout the treatment journey. And now, patients living with the most common type of leukemia – chronic lymphocytic leukemia, or CLL – have a new way to get answers to those common questions that often keep them and their loved ones awake at night.

Today, Adaptive received FDA clearance for the clonoSEQ® Assay to assess MRD in CLL, expanding the existing label to a third indication – and providing an important advancement for this community. It is the first and only FDA-cleared in vitro diagnostic for MRD monitoring in CLL, with the ability to measure 1 cancer cell among 1,000,000 healthy cells. This next-generation sequencing assay identifies the genetic sequence for each patient’s unique T or B cell cancer, and then counts the number of these cancer cells when needed, during and after treatment.

This clearance comes at a pivotal time. As newer CLL therapies drive deeper response, MRD testing is increasingly important to assess depth and durability of response.
The FDA’s decision was based on samples and outcomes data from two clinical trials which demonstrated:

• CLL patients with undetectable MRD (U-MRD) as measured by clonoSEQ had significantly reduced risk of disease progression compared to patients who did not reach U-MRD status. Patients with U-MRD (MRD < 10-5) by clonoSEQ had a nearly 7-fold decreased risk of disease progression, compared to MRD-positive patients (MRD ≥ 10-5).2
• clonoSEQ MRD results were significantly predictive of progression-free survival (PFS) in both blood and bone marrow samples, regardless of the threshold at which MRD was assessed.2

The CLL treatment landscape has changed dramatically in the last decade, with many new therapies available and a host of promising treatments on the horizon. Patients are living longer because of these advancements and as a result, clinicians need new ways to more accurately assess efficacy earlier in the patient’s treatment journey, either on approved therapies or in clinical trials for new drugs in development.

While clonoSEQ has been used for quite some time from a patient’s bone marrow in multiple myeloma and B-cell acute lymphoblastic leukemia, today’s additional indication in blood as well as bone marrow for CLL patients provides that patient population options for assessing MRD. Blood-based testing, available for the first time as an FDA-cleared use of clonoSEQ, provides patients and healthcare providers with a more convenient and less intrusive option to detect and monitor disease. This is especially advantageous during the time of COVID-19; as we all know too well, cancer doesn’t stop for anything, even a pandemic.

We believe that the value of knowing your clonoSEQ MRD status can be valuable to any patient with these types of blood cancers. To ensure patients have access to testing, Medicare coverage for clonoSEQ was expanded to include testing for patients with CLL in addition to patients with myeloma and ALL. The Medicare CLL coverage policy closely aligns with CLL clinical practice guidelines and supports testing in both blood and bone marrow at time points throughout a patient’s treatment.

There is no easy way to get through a cancer diagnosis and journey. But the ability to know how many cancer cells remain during and following treatment can bring peace-of-mind during a very stressful experience. We are humbled to play a small role in helping to improve patient care in this meaningful way.

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