Last week, the international myeloma community – physicians, pharmaceutical and biotechnology companies, academic centers, advocacy groups, and the U.S. FDA – published a paper on the application of measurable (or minimal) residual disease (MRD) determination in multiple myeloma (MM) for both the clinical care of patients and as a registrational pathway for new cancer treatments. As a hematologist/oncologist who has spent a significant portion of my career focused on improving diagnostic tools and their sensitivities in blood cancers, I am excited not only to have participated in the writing of this paper, but also the impact it may have on the field – physicians and especially patients.

The gold standard for assessment of response in MM has been “complete response” based primarily on morphological and serum paraprotein analyses. As the authors note, “Complete response (CR) by this conventional definition provided a false sense of disease control, since nearly all patients eventually relapsed despite achieving CR.” The introduction of next-generation flow cytometry and sequencing methodologies have significantly changed the method of measuring residual disease. Next-generation sequencing technologies like clonoSEQ are the first FDA cleared technologies to monitor and track MRD in individual patients over time. Accompanying these new methodologies, the development of novel agents has transformed the treatment paradigm for multiple myeloma. MRD can now be monitored with markedly increased sensitivity and MRD negativity is now achievable across the entire disease spectrum.

MRD testing at a single point in time provides insight into tumor burden at that moment. It is now clearly demonstrated that the achievement of MRD negativity predicts a better outcome compared to those at a similar stage who have not achieved a deep response to any therapy. Taken over multiple timepoints during a patient’s treatment journey, MRD testing can provide more detailed information about tumor biology and the likelihood of relapse. As a result, the authors of this paper observe that clinicians are now using MRD as an aid to real-time clinical management, and they call out the “essential” nature of longitudinal MRD measurements to the physician-patient dialogue around treatment planning.

As this is written, dozens of clinical trials are currently enrolling patients to evaluate MRD-directed therapy or MRD as an endpoint. The blood cancer community has long been rallying for MRD to be considered as a surrogate endpoint for both overall survival and progression-free survival in clinical trials. We are in a new era of medicine in multiple myeloma. New therapeutics (including proteasome inhibitors, monoclonal antibodies, and cell- based therapies) are having a significant positive impact on survival but, because of their efficacy and success, are making traditional trial endpoints hard to achieve within a time frame that is likely to be practically impactful for managing individual patients.  

MRD determination can be used in a variety of ways to expedite drug development. These include patient selection, risk stratification or enrichment, clinical management decisions, or as a trial endpoint. This is all great news for the multiple myeloma community; hopefully, the call-to-action presented in this paper will be recognized and further advance the field for the ultimate benefit of patients with myeloma.

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clonoSEQ® is available as an FDA-cleared in vitro diagnostic (IVD) test service provided by Adaptive Biotechnologies to detect minimal residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). clonoSEQ is also available for use in other lymphoid cancers and specimen types as a CLIA-validated laboratory developed test (LDT). For important information about the FDA-cleared uses of clonoSEQ including test limitations, please visit clonoSEQ.com/technical-summary.

In the wake of the COVID-19 pandemic, we applied our proprietary immune medicine platform to decode the immune response to the virus. We have mapped the T-cell immune response from more than 6,500 blood samples from individuals impacted by COVID-19 and made that data freely available to help researchers around the world to better understand why this disease affects some more than others, and to contribute meaningful solutions, including diagnostics, therapeutics, and vaccines.

Some parts of the world have begun to get the pandemic under control, thanks in large part to the biopharmaceutical industry which has done a heroic job accelerating the development of life-saving vaccines against SARS-CoV-2 and delivering them to patients in record-breaking time. However, the spread of the virus is not yet under control worldwide, and the emergence of new and potentially more dangerous variants remains a concern. As the virus continues to evolve, there is a pressing need for new vaccine strategies including next-generation vaccines to help end the pandemic and maximize the number of additional lives that can be saved.

A T-cell-based vaccine may provide more complete viral protection, long-term immunity and viral clearance against known and future variants of concern

The scientific community has learned that our bodies’ T-cell response is critically important in immunity to and protection from the SARS-CoV-2 virus. While antibodies are an important line of defense, T cells persist longer, and the T-cell response is much broader in that it recognizes many different parts of the virus.  Looking for other ways to harness the power of the T-cell immune response to develop better medicines for patients, Adaptive began studying T-cell epitopes. Epitopes are the small parts of viruses to which T-cells bind, thus triggering the immune response.

To date most vaccine makers have primarily focused on driving an antibody response, not a T-cell response, because it is much more difficult to identify specific parts of the virus to which T cells respond. As part of our work to decode the immune response to the virus, we have been able to characterize a comprehensive range of immunodominant T-cell epitopes – the parts of the virus which induce the strongest T-cell response – in both its ancestral and variant forms. These immunogenic bits of proteins can be used as a vaccine target to both prevent and treat COVID-19.

A next-generation T-cell based vaccine approach is promising and would enable us to enlist both the cellular and humoral parts of the adaptive immune system. By encoding a range of specific T-cell targets into the vaccine, we could generate a broader immune response with the potential to boost the antibody response already generated by first generation vaccines. This approach may give us a greater chance of weakening the virus’ ability to evade immune recognition as it mutates and to generate longer lasting protection.

Adaptive’s immune medicine platform can inform the design and development of vaccines

Earlier this week, Vaccibody, a clinical-stage biopharmaceutical company that is dedicated to the discovery and development of vaccines and novel immunotherapies, announced an exclusive license agreement with Adaptive to develop a next-generation vaccine powered by our knowledge of the T-cell response to SARS-CoV-2. Vaccibody’s vaccine candidates will specifically address emerging SARS-CoV-2 variants using the exact approach described above. Vaccibody’s T-cell based vaccine candidate may have both prophylactic and therapeutic potential and may also fit the profile of a universal vaccine booster for use with other SARS-CoV-2 vaccines.

Using their differentiated vaccine technology, Vaccibody will use T-cell epitopes identified and validated by Adaptive’s immune medicine platform to design and develop next-generation vaccines to fight the pandemic. The T-cell epitopes span multiple antigens across the SARS-CoV-2 genome, both on the spike and non-spike regions of the virus, to enable a much broader longer-lasting immune response and make it more difficult for current and future variants to evade. This is the first time that Adaptive’s platform is used to inform the design and development of vaccines.

This approach is versatile to develop vaccines across many different disease areas

This an important T-cell based vaccine clinical development program. Our Vaccibody collaboration is yet another validation of our platform to inform the design and development of novel, next-generation vaccines. We’re particularly excited to pursue additional applications of our platform that may inform the development of vaccines to prevent or treat many different diseases beyond COVID-19.

Adaptive is using its immune medicine platform to validate T-cell epitopes to hundreds of potentially clinically relevant targets in multiple diseases, paving the way for the development of an entirely new class of vaccines for other infectious diseases, autoimmune disorders and cancer. As with other technologies that came of age during the pandemic, this additional validation of our platform may allow us to be a key player in an era of novel target discovery and development of immune-mediated therapeutics to help tackle many other devastating diseases.

June is Lesbian, Gay, Bisexual, Transgender and Queer (LGBTQ) Pride Month:  a time to celebrate the LGBTQ+ community, while also remembering the history of Pride and the struggles our community has faced. As this year’s Month comes to an end, I reflect on how fortunate I am to work at Adaptive – a company that proudly supports its LQBTQ+ employees not just for one month, but throughout the year.  

Adaptive is committed to providing a culture that empowers, develops, and inspires our employees to bring their whole selves to work. I helped create the Adaptive Pride Employee Resource Group (ERG) – an employee-led group dedicated to offering support to our LGBTQ+ employees and fostering inclusion and diversity within Adaptive. Adaptive Pride also participates in community outreach programs that support and uplifts the LGBTQ+ community and allies. 

The inspiration for the Adaptive Pride ERG came about from a conversation I had with our CEO Chad Robins during a dinner in San Francisco several years ago. I told Chad that over the years, the fear of rejection has caused many LGBTQ+ people to try to be someone not truly ourselves – both professionally and socially. Instead, we try to be someone we think will be accepted by the people around us. Putting so much energy in trying to be someone you are not can be consuming and exhausting. It’s not productive – not for you, not for the company, not for our society, not for the world. 

Chad has always strongly believed in the uniqueness of people – that diversity in thought promotes innovation. That Adaptive should celebrate we’re not the same. We wanted to have a diverse workforce. We wanted to be welcoming, supporting, and respectful.  

We started thinking about how we could foster this culture of support and diversity and soon after created the Adaptive Pride and Women@Adaptive ERGs. It was not long before Adaptive participated its first Seattle Pride parade.  

The company made a formal statement that there will always be a place for LGBTQ+ people at Adaptive. I believe that, from a psychological perspective, if you are a person who laid low and didn’t feel comfortable talking about your sexual orientation, it is so liberating to hear directly from your CEO that “this company is a safe space for LGBTQ+ people to be whoever you are; just come to the table with your full self, we’re going to be OK with it, you don’t have to pretend to be someone else.”   

Chad set the tone and enabled us to begin learning about our fellow LGBTQ+ Adapters. Through events and involvement with the ERG you get to see a different part of someone you might not work with directly. We have created a special community within Adaptive that is supportive and valued.

I’m especially proud that now fellow LGBTQ+ Adapters feel more comfortable sharing openly about themselves. With Adaptive Pride we want to promote that we see you, we hear you, and we’re here to celebrate you and support you in whatever challenge that you have in the workplace and out. 

The Work Ahead 

Each year Adaptive chooses an organization to support during Pride Month. Last year it was Lifelong, an organization whose mission is to remove health barriers for those living with HIV, since they were on the frontline of helping the LGBTQ+ community impacted by COVID-19. This year we’re back to thinking about what we can do today to facilitate connection and strength in the LGBTQ+ community in the future. For us, that is making sure that young LGBTQ+ people feel safe and supported. 

The Trevor Project is a national organization providing crisis intervention and suicide prevention services to LGBTQ+ youth. It provides a hotline for youth in crisis, for situations where coming out to their parents didn’t go as planned and they don’t know what to do next. They can also receive counseling and support via text or chat to help navigate the process.  This is critically important because LGBTQ+ youth contemplate suicide at nearly 3x the rate of non-LGBTQ+ youth.  

Youth are always trying to determine who they are and who are their role models. Visibility and representation is key. Positive coming out stories, from people of all backgrounds, races, and religious beliefs create a path of representation that is critical for our LGBTQ+ youth.  

If we can help the young establish connection to a supportive community, we may be able to help some change the course of their lives. With potentially a good experience coming out and the space to be true to themselves, they won’t have to create layers that they will have to undo in their adult lives. They can just grow up as they are, free to reach their fullest potential. That’s how we’re going to develop the next generation of LGBTQ+ leaders.  

Celebrating Pride 

One of the best parts about Pride is that everyone can relate to this special celebration. It is about celebrating not only the LGBTQ+ community, but also celebrating that essence that we each feel inside, that essence that makes us truly unique. I’m glad that over the last several years at Adaptive, we have built a culture within our organization that showcases that we celebrate everyone’s uniqueness. We lift up the members of the LGBTQ community here and our many allies. We foster a sense of belonging where everyone can feel secure and safe to be who we are. We are each not only enough, but we are each also bringing something unique and wonderful to this community. That needs to be celebrated.

As the world strives to put the pandemic behind us, a burden of uncertainty continues to weigh on the minds of patients, physicians, and scientists. How durable is the immunity produced by vaccines or infection with SARS-CoV-2? To what degree does immunity extend to new variants?

The answers to these questions and more lie in a deeper understanding of the T-cell response to the virus.

T cells provide both the brain and the brawn that make our adaptive immune system so powerful. They are the first responders of the adaptive immune system and activate antibody responses. But they are underappreciated because they are more difficult to measure than antibodies.

What can T cells tell us about vaccine efficacy in the presence of variants?

Many of the variants make it easy for the virus to evade antibodies induced by the vaccines currently on the market¹. In theory this is dangerous, but across the board, all of the vaccines are providing strong efficacy even in the presence of variants—even, when the level of neutralizing antibodies is much lower. Why? The leading hypothesis is that T-cell response is not significantly affected by the variants.

SARS-CoV-2 variants escape neutralization by vaccine-induced humoral immunity

Antibodies work by binding to the virus itself and preventing it from entering cells. If the part of the virus to which the antibody binds is altered, its ability to “hang on” and thus prevent it from entering a cell is diminished. One big advantage of T cells is that they are highly specific and react to a much broader portion of the virus than antibodies, including areas outside of the spike protein. This is why T cells might provide protection against the variants, even when neutralizing antibody levels are low.

It turns out that to be protected against the COVID-19 virus, you don’t necessarily need a whopping neutralizing antibody response, you need a whopping adaptive immune response – and that includes both antibodies and T cells.

How do you measure the T-cell response?

T-cell research offers additional rich insights into immunity, creating a clearer picture of the total immune response. However, there are technical hurdles in measuring T cells accurately, and until recently, it wasn’t possible to to measure T cells at a population level.  This is exactly the problem we at Adaptive Biotechnologies set out to solve. Thanks to advanced sequencing, machine learning and cloud computing, we are now able to do this research with precision and scale never before possible.

Adaptive’s proprietary research and data analysis service, immunoSEQ® T-MAP COVID, combines the sequencing and mapping capabilities of our immune medicine platform to map T-cell receptors (TCRs) to disease-specific antigens. Over the course of the last year, we have acquired more than 6,000 patient samples to identify TCRs to all parts of the virus. Using this tool, we have been able to show how T cells respond to different parts of the virus, including the different parts of the spike protein. And, we have even been able to show exactly how the variants impact these parts of the virus, which can help us understand whether the immune response is likely to be affected. From the research done to date, we’ve proven that the most common parts to which T cells respond are not altered by mutations from the two most common viral strains, B.1.1.7 (UK) and B.1.351 (SA) (see chart below).

Vaccine-induced CD8+ T-cell Responses to Spike Protein Antigens

What makes this relevant in the real world? In peer-reviewed, published studies, it has been demonstrated that both the Astra Zeneca² and Johnson and Johnson³ vaccines generate a broader cellular immune  response against regions of the spike protein not impacted in any of the emerging variants, and are therefore very likely to contribute to protection from COVID-19.

What does this mean for determining immunity against the virus?

The development of vaccines against SARS-CoV-2 will go down as one of the greatest scientific and medical achievements in history. Tremendous progress has been made, and to sustain our success and re-entry into normal life, it is critical not to let our guard down.

More research is needed to clearly define and quantify T-cell-driven immunity so that we can know who is well-protected and who isn’t—at the individual and population level. As this virus becomes endemic in the population, as previous pandemic-causing pathogens have done, industry has already made a head start on next-generation vaccines. We need a reliable, sustainable, and quantitative way to measure the longevity of efficacy of the vaccines, and as we are seeing, the answers lie within the T cells.

To win the fight against COVID-19, it’s essential to understand the correlation between different markers of immunity and health outcomes. We are learning T cells can tell us more about immunity than antibodies, and immunoSEQ® T-MAP™ COVID is one of the most powerful tools available for probing the T-cell response.

1 Garcia-Beltran, et al. Multiple SARS-CoV-2 variants escape neutralization by vaccine-induced humoral immunity. Cell 2021.

2 Madhi et al. Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant. NEJM 2021.

3 Barouch et al. Immunogenicity of Ad26.COV2.S Against SARS-CoV-2 Variants in Humans. Nature 2021.

Adaptive Biotechnologies and the Personalized Medicine Coalition (PMC) co-hosted a congressional briefing to explore the rapidly emerging knowledge about the role of the adaptive immune system in combatting COVID-19. You can find a recording of the event here.
The panel, moderated by Cynthia Bens, head of public policy at PMC, brought together a diverse group of experts – representing doctors, scientists and patients. The briefing was held in collaboration with the Congressional Personalized Medicine Caucus, co-chaired by Sen. Tim Scott, Sen. Kyrsten Sinema, Rep Eric Swalwell, and Rep. Tom Emmer.
Three important points from the briefing include:

Immunity is complex and continued research is essential.

We heard about some of the important research being done through the SeroNet program and the COVID-19 Prevention Network to study individual differences in disease response and protection from vaccines or prior infection. The conversation highlighted the incredible complexity of immunity and underscored the need for expanded research efforts as these data are critical for informing public policies around vaccines, boosters and other public health measures to control the pandemic.

T cells are a fundamental piece of the immunity puzzle.

Antibodies are a critical part of our immune response, but they are only a fraction of the story. T-cell technologies are now available that have established that T cells can not only help us detect disease, but they may also provide a complementary measure of disease severity and protection. For example, T cells may provide key insights into vulnerable, immunocompromised populations who may not make sufficient antibodies. Studying the full adaptive immune response – both antibodies and T cells – may be the only way to answer critical questions for these populations.

Progress comes from collaborating across sectors, together with patients.

These 15 months of unprecedented medical advancements were accelerated by partnerships between public and private entities across industry, academia and non-profits, and – of course – none of this would have been possible without the millions of patients, survivors and their families. Fostering this spirit of collaboration will help drive medical progress against disease and better prepare us for a future pandemic.
Learn more about Adaptive Biotechnologies’ contributions to COVID research and detection.

In March 2021, the blood cancer community celebrated a big win for those living with multiple myeloma (MM) with the FDA approval of Abecma^® (idecabtagene vicleucel), the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory MM after four or more prior lines of therapy. MM is a blood cancer in which abnormal plasma cells build up in the bone marrow and form tumors in bones. Despite advances in treatment, MM remains an incurable disease.

Innovative treatments such as Abecma are critical for moving the needle forward in the MM treatment landscape. Abecma is made from a patient’s own T cells, the adaptive immune system’s first responders to detect any virus, which are reprogrammed to find and destroy specific target cells.

The clinical trials that evaluated Abecma assessed minimal residual disease (MRD) using Adaptive’s clonoSEQ^® Assay, the first and only FDA-cleared assay for minimal residual disease (MRD) in select blood cancers, including MM. MRD refers to the small number of cancer cells that can stay in the body during and after treatment. An MRD-positive test result means that disease was still detected after treatment, while an MRD-negative result means no disease was detected after treatment. Because MRD is a direct measure of disease, assessing its presence and level is a powerful way to evaluate a patient’s response to treatment, dynamically evaluate prognosis, monitor remissions, and detect early signs of potential recurrence.

We sat down with Jenny Ahlstrom, a MM patient and founder of the advocacy organization Myeloma Crowd, to discuss what the approval of Abecma means for the MM community. Jenny also provided insight into the role of MRD testing in treatment decision-making, its use in clinical trials, and the future treatment landscape for MM.

Q: What does the FDA approval of the first CAR T cell therapy for MM mean for patients?

Jenny Ahlstrom: The Myeloma Crowd Advisory Board was an early funder of CAR T, and the FDA approval of the first CAR T cell therapy for the treatment of patients with relapsed/ refractory MM who have been treated with four or more prior lines of therapy is a watershed moment for the community.

T cells are an important part of the immune system, and the use of a patient’s own immune cells to fight MM opens up a whole new world. This approval represents a new way of thinking about how to treat MM patients, many of whom relapse following initial therapy.

Q: How will having a CAR T cell therapy for MM change the treatment landscape and outcomes for patients? What’s next?

Jenny Ahlstrom: I think eventually CAR T cell therapy will be moved up earlier in the treatment paradigm. Now that we have seen such high response rates with CAR T cell therapy, we will next want to determine how to extend and maintain them. We will also want to evaluate whether earlier use of CAR T cell therapy can maintain longer remissions, and if additional therapies added to the treatment regimen following CAR T cell therapy can help patients maintain a response. There is more research to be done, but with so many innovative treatments available now for MM, I believe we will find the best treatment sequencing and combinations for patients over time.

Q: Why is it important for patients to know about MRD and MRD testing? 

Jenny Ahlstrom: MRD is a tool, and the more tools we have in the toolbox for managing patients with cancer, the better!

Continuously monitoring patients for disease progression during and after treatment can provide meaningful information and inform treatment decisions. Whether a patient was just diagnosed or has been through multiple prior therapies, MRD testing gives hematologists/ oncologists a personalized way to track the patient’s individual response to treatment. The fact that Abecma can help patients achieve MRD negativity even after 4+ lines of prior therapy demonstrates that MRD testing has value for monitoring depth of response at all points throughout the treatment continuum.

Patients always want to know if they are in jeopardy of relapsing and what can be done about it, but they don’t want to wait until a full relapse. They want to know right away. With MRD testing, their physician can see if they may be heading toward a relapse and take immediate action to develop a personalized treatment plan, so their disease doesn’t continue to grow.

For patients in remission, periodic MRD testing can provide peace of mind, especially given how prevalent relapse is in this patient population. MRD testing also can be helpful in guiding patients who want to stop receiving maintenance therapy, which can be associated with side effects and financial costs.

Q: What other benefits does MRD testing provide to patients?

Jenny Ahlstrom: The more data patients and physicians have, the better. With MRD results in hand, hematologists/oncologists can show patients how their immune system is responding to treatment. With this data, doctors can have more informed conversations with patients about treatment goals and effectiveness and future prognosis – and patients are better equipped to participate in the discussion about managing their disease.

Q: What is the level of awareness around MRD within the MM patient community? 

Jenny Ahlstrom: Patients newly diagnosed with MM are overwhelmed and getting information to them is challenging. They must make critical decisions in a matter of days. They must self-advocate. They need to watch their numbers. Furthermore, if they are not being treated at an academic center, where MRD testing is more common, they may not be familiar with MRD or even know to ask for it. Our goal at Myeloma Crowd is to reach these patients at the beginning of their journey with the disease so we offer a wealth of resources.

Q: As the treatment landscape for blood cancers continues to evolve, what role will MRD testing have in clinical practice and in clinical trials?

Jenny Ahlstrom: You’ll likely see today’s “standard” therapy for newly diagnosed patients change over the next few years to incorporate more immunotherapy up front. Treatment is becoming more nuanced, and MRD testing is a tool to help with that. As the number of effective treatment options continues to expand, the number of patients who reach late lines of therapy is growing, making the ability to confirm deep and durable MRD-negative responses in the salvage setting increasingly important. MRD testing is not only a reliable method for understanding a patient’s prognosis and outcome, it also may be important in helping sequence CAR T and other innovative treatments in the right way to prolong survival.

MRD is also an important tool that could benefit clinical trial design and help speed up studies. When MRD is used as an endpoint, it can provide results about whether a patient is responding to treatment in a much shorter timeframe than using overall survival as an endpoint – in 3 to 5 years vs. 8 to 10 years – and help us learn more, faster.

“By enabling this exploration of the human adaptive immune universe, Adaptive is powering the age of immune medicine to ultimately improve all human lives.”

The “heartbeat” of Adaptive is our laboratory operations. Our work to improve patients’ lives begins with our lab operations and biological sample management teams. Nearly every hour of every day, the team of professionals in our labs in Seattle and South San Francisco are working diligently to process biological samples from patients who are looking for answers to important questions about their health. With Medical Laboratory Professionals Week now underway, it’s a perfect opportunity to shine a light on our lab operations and celebrate the team members who work conscientiously to benefit patients around the world.

My colleague Hugh Arnold, Ph.D., chief of staff, operations management, uses a great analogy to explain what we do at Adaptive: “In the past, researchers and clinicians exploring the adaptive immune system could only see tens, hundreds or thousands of T and B cells in a patient – a minuscule fraction. With our sequencing and technology, scientists now can look at hundreds of thousands, millions or even billions of these critical immune cells.”

“This is the equivalent of how early astronomers looking through telescopes could see only the moon, the planets in our solar system and their moons, and the hundreds or thousands of stars in our galaxy. But now, with the wide array of technologies available to explore the far reaches of the universe, astronomers can explore the billions of stars in our own galaxy as well as countless other galaxies, each with billions of their own stars. By enabling this exploration of the human adaptive immune universe, Adaptive is powering the age of immune medicine to ultimately improve all human lives.”

Our biological sample management teams are the “gatekeepers” of our operations. They receive and accession patient samples ready for the Production Laboratory teams to then extract DNA and prepare it for the next steps of polymerase chain reaction (PCR) and sequencing. The results are assessed for quality before being used to make important clinical decisions in treating patients. They also upload the sequenced data to our vast clinical immunomics database where our researchers use it to develop new diagnostics and therapeutics for patients.

When the COVID-19 pandemic hit in 2020, our lab professionals faced daunting challenges to keep the lab running uninterrupted. Despite shelter-in-place orders and other restrictions, our team worked tirelessly to ensure we could continue to provide lab results of the highest quality. They rose above the uncertain and unsettling circumstances and found ways to continue serving patients. In fact, their steadfast work not only maintained our ongoing work, but also led to the development and launch of T-Detect™ COVID – the first T cell-based test for detecting whether an individual has had a recent or past SARS-CoV-2 infection. With this test, we have proven it is possible to read how T cells detect disease in the blood, and we are on a path to develop this product for many other potential indications, including Lyme disease, Crohn’s disease and cancer. Additionally, our lab team turned challenges presented by the pandemic into opportunities to make continuous improvements, expand capacity in our lab facilities, and prepare for operations post-COVID-19.

For all of the members of our lab team who continue to do their critical jobs with passion, purpose and pride, we salute and thank them for their incredible work and dedication – not just during Lab Week 2021, but every day of the year.

For just a few months in late 2019/early 2020, for the first time in history, the number of women in the workforce overtook the number of men. What an incredible milestone when you think about it!

Unfortunately, this did not last long. Nearly 3 million women have left the US workforce in the last year. The pandemic has sharply pushed us back a generation, with the number of women in the workforce now reverting back to levels not seen since I was growing up in the 1980s, when it was frankly more common to have a mom that stayed at home than a mom who worked. For many people, disproportionately for women, it became impossible to keep working when faced with losing childcare, having kids at home instead of at school, and taking on new responsibilities such as home-school teachers and home IT administrators.

I consider myself lucky among my peers.

When I interviewed at Adaptive a few years ago, I was excited about coming to work at this innovative biotech based in Seattle. However, being newly married with two tween stepdaughters and a home base in Boston, relocating across the country was a non-starter. On top of that, while I was interviewing, I found out I was pregnant. When I told my now-boss, Julie Rubinstein, about my pregnancy, to my surprise, she told me how genuinely thrilled she was for me. She assured me that if I wanted to move forward, we would figure it all out. That conversation set the tone for me. I accepted the offer. From that day forward, I have been able to continue investing heavily in my career and my company in a way that has also allowed me the flexibility to work remotely and be a mom. This is one of the reasons I feel especially committed to Adaptive to this day.

Don’t get me wrong – the hours are long and the work is hard. Biotech is an intense industry in normal times. The added stress of the COVID-19 pandemic and Adaptive’s work in this space made for a wild year in quarantine. Everyone on my team and my coworkers have struggled, trying to balance dramatically increased work demands, our partners, our kids, personal lives and commitments, on top of the heavy burden of the uncertainty we were all facing in the world. As a leader, I was in a position where I could afford my team and my coworkers the same empathy and flexibility I have always had, knowing that the executive team and company had my back.

I am well aware that my experience has not been the norm. We have been so fortunate at Adaptive – the flexibility, support, and understanding that starts at the very top has been felt throughout the company during the pandemic, and we’ve experienced very few losses as a result. Many of my friends and peers at other companies have had to make the hard choice to put their careers on pause because it was simply not possible to manage kids’ needs and schedules, particularly without the network of friends and other parents we typically rely on for support. As I think about the range of different scenarios women have faced over the last year trying to ‘do it all,’ none of it seems fair.

As we move towards re-opening, we are now dealing with the realities of the “new normal” in different ways. In Seattle, where children in public schools have the option to return in person for 2.5 hours a day – a great first step to get kids back in school – working parents are faced with a logistical nightmare. It’s difficult to know what the future holds, or how we will recapture the progress that was so hard fought for women. However, I would like to offer a few lessons learned that may help other employers and leaders as we near the end of the pandemic, to create more inclusive workplaces going forward:

1. Be flexible. Support employees with personal obligations outside of work, whether children, parents, or spouses, with flexibility. This investment in people will be paid back in droves. Employees who know that the other parts of their lives are valued and respected by their managers and employers will be more than willing to work “off-hours” (whatever that means nowadays) and feel more committed to their work. And let’s be honest – 9 to 5 is a thing of the past – which brings me to my next point.
2. Work-life integration vs. work-life balance is here to stay. These rules don’t just apply in a pandemic. The past year has accelerated a trend that has progressed throughout my career. People are connected 24/7, everywhere they go. As employees, that often means that we are expected to be “on call” in a way that was frankly never possible in the past. By giving people the ability to disconnect when they need to, no matter what time that is, it gives people the freedom to attend to personal commitments and bring their full selves to work at a time when they can work productively and think clearly.
3. It’s not just a women’s issue. As the pandemic has upended work and home life, women have carried an outsized share of the burden, more likely to shoulder the load of work at home, from cooking meals, supporting remote learning, and dealing with other logistics that fall out from closed schools and day care. So, importantly, this isn’t only about supporting women. It is also about extending that support to men to enable an overall more balanced share of care and family responsibilities.

This past year has put our personal lives on display to all our colleagues – the hopes and the fears, the joys and the messiness. As we round the corner past the challenges and tragedy, let’s find the silver lining and take the opportunity to focus on what we’ve learned and how it can change our lives for the better.

Imagine if a simple blood test could provide accurate and early diagnosis of thousands of different diseases simultaneously? That is no easy task, but it may be possible using new technology that can leverage how our body naturally detects diseases using nature’s most finely-tuned diagnostic—the adaptive immune system.

At Adaptive Biotechnologies, we just launched T-Detect COVID, the first-ever T-cell test for individuals that can detect whether a person has had a recent or past COVID-19 infection. The development of this test was made possible by combining Adaptive’s understanding of how the immune system works with Microsoft’s AI and machine learning capabilities. Importantly, this is the first of many potential diseases that we can detect by looking at the T-cell response and represents a paradigm shift in how we diagnose, and ultimately treat, many different illnesses based on how the immune system naturally does this. We call this Immune Medicine.

The adaptive immune system: a massive but solvable machine learning problem

T cells are the first responders of the adaptive immune system and activate the antibody response. These cells have specialized receptors which must be extraordinarily diverse to recognize one or a small number of the millions of antigens to which our bodies are continuously exposed.

To understand how the immune system responds to disease, we are translating the diverse genetic code of these receptors into data so that it can be analyzed both at the individual level and across entire populations. This is no easy task, and that is why we are collaborating with Microsoft. With their advanced AI and machine learning technologies, we have the ability to comb through this massive data set, effectively creating a “map” of these immune cells to most diseases. Ultimately, we have translated the complex biology of the adaptive immune system into a machine learning problem which is massive, but tractable.

When we partnered with Microsoft, we recognized that solving a challenge of this nature had never been done before. However, the result would be a true breakthrough—a simple blood sample that would reveal what diseases the body is currently fighting or has ever fought.

Rising to the challenge: COVID-19

When COVID-19 hit in 2020, we knew we could help those impacted by COVID-19 by applying these capabilities to the pandemic, collecting thousands of blood samples to map the T-cell response to SARS-CoV-2, the virus the causes COVID-19.

One of the limiting factors of traditional antibody tests—blood tests that look for antibodies to SARS-CoV-2—is that antibodies wane over time, meaning after a while you may not be able to detect whether you have previously had the virus. While T cells also wane over time, they stay in your body considerably longer than antibodies.

Testing T-cell levels in response to COVID-19 may therefore be an important complement to antibody testing to identify recent or prior infections. And, importantly, T cells may also help us better understand one’s immunity and protection either from natural infection or from a vaccine. This is especially important as new variants appear and the population starts to get vaccinated.

Just the tip of the iceberg

T-Detect COVID provides proof for our ultimate vision to enable early and accurate detection of many diseases from a single blood test – in fact we are already validating T-Detect for many other diseases. To date, we have confirmed two other signals: Lyme disease and Crohn’s disease, which are at advanced stages of development in our pipeline. We are also evaluating multiple tumor types for early and accurate detection of cancer in our T-Detect pipeline. As we continue in this endeavor with Microsoft, we are rapidly learning more that will enable us to use T cells to diagnose thousands of other diseases. Understanding the adaptive immune system is not only an important step in diagnosing many different diseases but also may ultimately help to develop novel, immune-based treatments.

T-Detect COVID is available for research use only. T-Detect COVID is not available for clinical use.

Eighteen years ago, I began a journey with my dad that profoundly impacted me personally and professionally. At the time, I was expecting my oldest daughter Emily when my healthy and active father was diagnosed with a rare and then hard-to-treat bone marrow disorder called myelofibrosis.

With limited treatment options, this diagnosis did not have a great prognosis. Through the incredible organization Gift of Life, my dad was twice matched with selfless bone marrow donors, enabling him to undergo two separate life-saving stem cell transplants. Five years ago, thanks to scientific advances, I was able to be his donor for a third transplant.

During that time, I experienced first-hand that we could save lives by looking within ourselves. For hundreds of millions of years, the body’s immune system has been evolving to better protect us and keep us healthy. It’s a force inside your body so powerful that most of the time, it’s able to detect and fight disease —often before you even realize that you’re sick. Our body’s capability is nothing short of amazing.

At Adaptive Biotechnologies, we believe that we have a great opportunity to harness this capability to power a new era of medicine – which we call immune medicine – to detect and treat disease by learning from the way the body’s immune system does it naturally. Many of the clinical products we have developed are using our technology to help people with certain leukemias and lymphomas detect the smallest amount of remaining blood cancer cells that can stay in the body during and after treatment or transplant –a sign that the cancer is returning.

We are also working in partnership with Genentech to leverage our immune medicine platform to identify T-cell receptors – the first responders of your adaptive immune system to recognize cancer – that can be engineered into cellular therapies for cancer patients. The progress in this area has been amazing and life changing for so many people in need of new treatment options.

On this World Cancer Day, I am in awe of the cancer community and the resiliency that has been shown during this especially difficult time. Patients are still fighting. Caregivers continue to show up. Physicians are seeing their patients. Donors are still raising money. Research advances. At Adaptive, our lab and lab support staff have continued to show up every day, despite their own personal hardships caused by this pandemic.

The power of the human body to fight disease is nothing short of extraordinary and the individual stories behind every immune system are unique. By decoding these stories, we can create better endings for more people battling disease, whether it’s cancer, COVID-19, or beyond.

Today, at the young age of 78, my dad is cured. As a long-time volunteer and board member for The Valerie Fund, I’ve had a front seat to witness the incredible therapeutic advances that are leading to more cures in children with cancer and blood disorders. At Adaptive, we will continue to innovate to give everyone this same chance.