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GEN Protocols Expert Exchanges: COVID-19 Immunodiagnostic Test to Identify Antibody Source with Tadd Lazarus, MD
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GEN Protocols Expert Exchanges: COVID-19 Immunodiagnostic Test to Identify Antibody Source with Tadd Lazarus, MD
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Language: EN.
Segment:0 .
[MUSIC PLAYING]
ANJALI SARKAR: Hello, fellow scientists and science lovers. This is Anjali Sarkar, Senior Science Editor at GEN and GEN Protocols welcoming you to GEN Protocols Expert Exchange. GEN Protocols is a primary resource for emerging and veteran scientists and industry leaders who want to know more about technical advancements in biotechnology from a trusted source. Researchers from academia and industry share and showcase their technical expertise, nurture collaborations, and discuss technical challenges and solutions on GEN Protocols.
ANJALI SARKAR: We are open for submission year-round, where experts in key areas of biosciences and biotechnology, talk about method-focused developments, challenges, and visions. In today's Expert Exchange, I will be talking to Tadd Lazarus, Chief Medical Officer at Pictor about a new test called PictArray that helps you decide whether you need another COVID-19 booster shot by telling you exactly where your antibodies to the virus are coming from.
ANJALI SARKAR: That is, if your antibodies are from vaccines, or SARS-CoV-2 infections, or both. Welcome to GEN protocols, Tadd.
TADD LAZARUS: Thank you for having me. I'm happy to be here with you today.
ANJALI SARKAR: So before we begin, could you tell us a bit about yourself and your current role at Pictor?
TADD LAZARUS: Well, I'm a medical doctor. Internal medicine is my specialty. But I always was in the laboratory, especially during my internship and residency. I was very lucky where I trained, the pathologists encouraged my great interest in the laboratory and in laboratory medicine and never made it a bother. It was very interesting to me that during the HIV/AIDS epidemic where I worked as an HIV primary care doctor and ran a large HIV primary care outpatient program in New York City, I was recruited to Roche Diagnostics in the late '90s.
TADD LAZARUS: And it was a very nice place, because it was like coming home again. It was as if all those late nights and discussions with the pathologists had prepared me for something that was of enormous interest to me. So my career went from strictly academic and clinical to branch out to industry, both investigative and commercial.
ANJALI SARKAR: So when you joined Pictor, what inspired the development of PictArray, would you say?
TADD LAZARUS: The technology had been worked on and applied in other infectious disease areas by Pictor. And it's really quite unique. It's highly multiplexed antibody assay, plate-based with a reader. But the degree of multiplexing hadn't been achieved before. And so, the degree of sensitivity and specificity across a very large dynamic range also hadn't been achieved before in other ELISA antibody-based tests.
TADD LAZARUS: So it's, to me, very exciting. I have spent my career working in epidemic and pandemic response, whether it's been in HIV/AIDS or the huge amount of tuber-- excuse me, TB, and hepatitis B and C, MERS, SARS, and now working in COVID-19. It's nice to be able to apply cutting-edge technology to help when it's really needed.
ANJALI SARKAR: Definitely. So before we go into more specific questions, could you describe Pictor's PictArray test and explain what the test accomplishes?
TADD LAZARUS: Yes, the test uses neutralizing IgG antibody to the spike protein and to the nucleocapsid protein. And in this manner, it's able to differentiate antibody response to-- for a patient who has had an antibody response from vaccination or antibody response from prior exposure.
ANJALI SARKAR: So given the simplicity of the test that the press release has announced, can this test be used at home by patients at a point of care themselves or is it to be used exclusively in clinical diagnostic labs?
TADD LAZARUS: Yeah. It's really to be used in a clinical diagnostic laboratories. It requires phlebotomy at this point. And it's run on a blood sample.
ANJALI SARKAR: OK. And when should people use this test?
TADD LAZARUS: There are a variety of times that would be a very good idea. But I think one of the most important is that people are experiencing vaccine fatigue. So many people have had a first and second dose of Moderna or Pfizer. Many have had the first booster but then are dragging their feet and just feeling a bit burnt out to get the second booster.
TADD LAZARUS: Now, this is particularly worrisome, especially for our elderly, people who are immunosuppressed, such as patients receiving immunosuppressive anti-rejection agents or cancer chemotherapy, people with autoimmune disease, et cetera. So it's a way for people who are having vaccine or booster fatigue to get a better sense of being motivated to get their second booster, so to speak, and for populations at risk to know where they stand.
TADD LAZARUS: Don't forget, the elderly often don't have a sufficient immune response to vaccination. That problem is existent with people with HIV/AIDS, cancer, on a variety of suppressive drugs, et cetera. And we have a monoclonal antibody that can be given to people also if they haven't been exhibiting a proper response.
TADD LAZARUS: So I think at many levels to deal with vaccine fatigue, to identify patients who potentially wouldn't mount of sufficient antibody response, and to line them up for exogenous antibody treatment. So I think that those are some of the really important uses for it.
ANJALI SARKAR: Before we go on, could you explain exactly what is meant technically by vaccine fatigue?
TADD LAZARUS: Well, yes. For many, the vaccinations are not without side effects. Local pain, stiffness, feverishness, generalized malaise, they can last a number of days. And just because you have the symptoms once doesn't mean you won't have it every time you receive the vaccine or a booster. And people get a bit tired of having the side effects, not feeling too well for a couple of days, and then wondering, do I really need to put myself through this again?
TADD LAZARUS: The answer is, yes, you do. And all the studies are very clear about that. The second question is that people always ask is, I've had documented COVID-19 infection. Don't I have lifelong antibodies? And the answer is, no. [LAUGHS] And in fact, naturally produced antibodies to the infection actually appeared to last a shorter amount of time than those from the vaccine.
TADD LAZARUS: Who appears to do the very best? People who have natural immunity plus vaccination they tend to have very high neutralizing antibodies. So there are a lot of areas where fatigue can set in. And there are a lot of questions people still have. This is one way for people to have objective evidence to motivate them to complete their course. And I think most people agree now that a full course is first and second vaccination, first booster at the appropriate time, and second booster at the appropriate time.
ANJALI SARKAR: So as I understand the PictArray test tells you the source of the antibodies. Why is it clinically important to sort out the source of SARS-CoV-2 antibodies in the system?
TADD LAZARUS: Well, it's very important for vaccine research, especially, to know where the antibodies are coming from. It's important also because people want to know if they have had infection that they missed. And they want to know what their past course has been.
ANJALI SARKAR: And how does the PictArray test determine where the patient antibodies are coming from?
TADD LAZARUS: Yes. So if the patient has had a recent infection, they'll be elaboration of antibodies towards the spike protein and the nucleocapsid protein. If it's just antibody elaboration after vaccination, there will be antibody elaboration against the spike protein only.
ANJALI SARKAR: And from a public health perspective, how important do you think this test will be in determining whether an individual needs a second or successive booster shots?
TADD LAZARUS: Yes. It's an excellent question. I really do feel that we will be profiling segments of the population over time to help make certain that people are maintaining levels of protection. It appears that COVID-19 is not going to be going anywhere or going away soon. And that the only way to not continue to have, tragically what was announced today, having over a million deaths in the United States from COVID-19 to not continue that bleak story, is to make certain that we have a well-boosted timely vaccinated population with adequate antibodies.
ANJALI SARKAR: Right. So will the test remain effective as the virus evolves into new strains or will modifications to the test be made, and are those in the pipeline?
TADD LAZARUS: Well, we always keep track of everything. And we certainly do monitor the effectiveness of the test. But these are antibodies to really conserved regions of the spike protein and the nucleocapsid. And we very much believe that it will continue to have excellent efficacy over time.
ANJALI SARKAR: Excellent. You mentioned that these tests are primarily for use in clinical diagnostic labs. Some of these labs are larger than others and have a lab automation available. How amenable is this compact test to be integrated into existing lab automation technologies? And on the other hand, how convenient is it for smaller labs that do not have any automation capacity?
TADD LAZARUS: Yes. So it's a great question you're asking. And obviously, laboratory automation is for two reasons. One, it's to achieve high volume. And one, it's to limit the amount of time an individual laboratory technologist has to spend on performing a test. Obviously, there's always been a great advantage to using these kind of antibody tests, because they come in a 96-well plate and you can do an enormous number of patient tests in one run.
TADD LAZARUS: It's not a difficult or time-consuming test for the laboratory technologist. And then, the reading of the plate is done with an automated plate reader. So all in all, it's not a terribly intrusive test. And it certainly isn't anything like the early days of PCR, where a laboratory's best technologists would spend really an entire day running one group of patient tests.
TADD LAZARUS: And I certainly do remember those days.
ANJALI SARKAR: That brings us to the end of today's GEN Protocols Expert Exchange. Thank you, Dr. Lazarus, for a very illuminating discussion. A reminder to all scientists and viewers in our audience, GEN Protocols is open for submissions. And we welcome your protocols in all aspects of biotechnology. This is Anjali Sarkar. Until next time, good luck in your research and goodbye from all of us at GEN Protocols. [MUSIC PLAYING]
Segment:0 .
[MUSIC PLAYING]
ANJALI SARKAR: Hello, fellow scientists and science lovers. This is Anjali Sarkar, Senior Science Editor at GEN and GEN Protocols welcoming you to GEN Protocols Expert Exchange. GEN Protocols is a primary resource for emerging and veteran scientists and industry leaders who want to know more about technical advancements in biotechnology from a trusted source. Researchers from academia and industry share and showcase their technical expertise, nurture collaborations, and discuss technical challenges and solutions on GEN Protocols.
ANJALI SARKAR: We are open for submission year-round, where experts in key areas of biosciences and biotechnology, talk about method-focused developments, challenges, and visions. In today's Expert Exchange, I will be talking to Tadd Lazarus, Chief Medical Officer at Pictor about a new test called PictArray that helps you decide whether you need another COVID-19 booster shot by telling you exactly where your antibodies to the virus are coming from.
ANJALI SARKAR: That is, if your antibodies are from vaccines, or SARS-CoV-2 infections, or both. Welcome to GEN protocols, Tadd.
TADD LAZARUS: Thank you for having me. I'm happy to be here with you today.
ANJALI SARKAR: So before we begin, could you tell us a bit about yourself and your current role at Pictor?
TADD LAZARUS: Well, I'm a medical doctor. Internal medicine is my specialty. But I always was in the laboratory, especially during my internship and residency. I was very lucky where I trained, the pathologists encouraged my great interest in the laboratory and in laboratory medicine and never made it a bother. It was very interesting to me that during the HIV/AIDS epidemic where I worked as an HIV primary care doctor and ran a large HIV primary care outpatient program in New York City, I was recruited to Roche Diagnostics in the late '90s.
TADD LAZARUS: And it was a very nice place, because it was like coming home again. It was as if all those late nights and discussions with the pathologists had prepared me for something that was of enormous interest to me. So my career went from strictly academic and clinical to branch out to industry, both investigative and commercial.
ANJALI SARKAR: So when you joined Pictor, what inspired the development of PictArray, would you say?
TADD LAZARUS: The technology had been worked on and applied in other infectious disease areas by Pictor. And it's really quite unique. It's highly multiplexed antibody assay, plate-based with a reader. But the degree of multiplexing hadn't been achieved before. And so, the degree of sensitivity and specificity across a very large dynamic range also hadn't been achieved before in other ELISA antibody-based tests.
TADD LAZARUS: So it's, to me, very exciting. I have spent my career working in epidemic and pandemic response, whether it's been in HIV/AIDS or the huge amount of tuber-- excuse me, TB, and hepatitis B and C, MERS, SARS, and now working in COVID-19. It's nice to be able to apply cutting-edge technology to help when it's really needed.
ANJALI SARKAR: Definitely. So before we go into more specific questions, could you describe Pictor's PictArray test and explain what the test accomplishes?
TADD LAZARUS: Yes, the test uses neutralizing IgG antibody to the spike protein and to the nucleocapsid protein. And in this manner, it's able to differentiate antibody response to-- for a patient who has had an antibody response from vaccination or antibody response from prior exposure.
ANJALI SARKAR: So given the simplicity of the test that the press release has announced, can this test be used at home by patients at a point of care themselves or is it to be used exclusively in clinical diagnostic labs?
TADD LAZARUS: Yeah. It's really to be used in a clinical diagnostic laboratories. It requires phlebotomy at this point. And it's run on a blood sample.
ANJALI SARKAR: OK. And when should people use this test?
TADD LAZARUS: There are a variety of times that would be a very good idea. But I think one of the most important is that people are experiencing vaccine fatigue. So many people have had a first and second dose of Moderna or Pfizer. Many have had the first booster but then are dragging their feet and just feeling a bit burnt out to get the second booster.
TADD LAZARUS: Now, this is particularly worrisome, especially for our elderly, people who are immunosuppressed, such as patients receiving immunosuppressive anti-rejection agents or cancer chemotherapy, people with autoimmune disease, et cetera. So it's a way for people who are having vaccine or booster fatigue to get a better sense of being motivated to get their second booster, so to speak, and for populations at risk to know where they stand.
TADD LAZARUS: Don't forget, the elderly often don't have a sufficient immune response to vaccination. That problem is existent with people with HIV/AIDS, cancer, on a variety of suppressive drugs, et cetera. And we have a monoclonal antibody that can be given to people also if they haven't been exhibiting a proper response.
TADD LAZARUS: So I think at many levels to deal with vaccine fatigue, to identify patients who potentially wouldn't mount of sufficient antibody response, and to line them up for exogenous antibody treatment. So I think that those are some of the really important uses for it.
ANJALI SARKAR: Before we go on, could you explain exactly what is meant technically by vaccine fatigue?
TADD LAZARUS: Well, yes. For many, the vaccinations are not without side effects. Local pain, stiffness, feverishness, generalized malaise, they can last a number of days. And just because you have the symptoms once doesn't mean you won't have it every time you receive the vaccine or a booster. And people get a bit tired of having the side effects, not feeling too well for a couple of days, and then wondering, do I really need to put myself through this again?
TADD LAZARUS: The answer is, yes, you do. And all the studies are very clear about that. The second question is that people always ask is, I've had documented COVID-19 infection. Don't I have lifelong antibodies? And the answer is, no. [LAUGHS] And in fact, naturally produced antibodies to the infection actually appeared to last a shorter amount of time than those from the vaccine.
TADD LAZARUS: Who appears to do the very best? People who have natural immunity plus vaccination they tend to have very high neutralizing antibodies. So there are a lot of areas where fatigue can set in. And there are a lot of questions people still have. This is one way for people to have objective evidence to motivate them to complete their course. And I think most people agree now that a full course is first and second vaccination, first booster at the appropriate time, and second booster at the appropriate time.
ANJALI SARKAR: So as I understand the PictArray test tells you the source of the antibodies. Why is it clinically important to sort out the source of SARS-CoV-2 antibodies in the system?
TADD LAZARUS: Well, it's very important for vaccine research, especially, to know where the antibodies are coming from. It's important also because people want to know if they have had infection that they missed. And they want to know what their past course has been.
ANJALI SARKAR: And how does the PictArray test determine where the patient antibodies are coming from?
TADD LAZARUS: Yes. So if the patient has had a recent infection, they'll be elaboration of antibodies towards the spike protein and the nucleocapsid protein. If it's just antibody elaboration after vaccination, there will be antibody elaboration against the spike protein only.
ANJALI SARKAR: And from a public health perspective, how important do you think this test will be in determining whether an individual needs a second or successive booster shots?
TADD LAZARUS: Yes. It's an excellent question. I really do feel that we will be profiling segments of the population over time to help make certain that people are maintaining levels of protection. It appears that COVID-19 is not going to be going anywhere or going away soon. And that the only way to not continue to have, tragically what was announced today, having over a million deaths in the United States from COVID-19 to not continue that bleak story, is to make certain that we have a well-boosted timely vaccinated population with adequate antibodies.
ANJALI SARKAR: Right. So will the test remain effective as the virus evolves into new strains or will modifications to the test be made, and are those in the pipeline?
TADD LAZARUS: Well, we always keep track of everything. And we certainly do monitor the effectiveness of the test. But these are antibodies to really conserved regions of the spike protein and the nucleocapsid. And we very much believe that it will continue to have excellent efficacy over time.
ANJALI SARKAR: Excellent. You mentioned that these tests are primarily for use in clinical diagnostic labs. Some of these labs are larger than others and have a lab automation available. How amenable is this compact test to be integrated into existing lab automation technologies? And on the other hand, how convenient is it for smaller labs that do not have any automation capacity?
TADD LAZARUS: Yes. So it's a great question you're asking. And obviously, laboratory automation is for two reasons. One, it's to achieve high volume. And one, it's to limit the amount of time an individual laboratory technologist has to spend on performing a test. Obviously, there's always been a great advantage to using these kind of antibody tests, because they come in a 96-well plate and you can do an enormous number of patient tests in one run.
TADD LAZARUS: It's not a difficult or time-consuming test for the laboratory technologist. And then, the reading of the plate is done with an automated plate reader. So all in all, it's not a terribly intrusive test. And it certainly isn't anything like the early days of PCR, where a laboratory's best technologists would spend really an entire day running one group of patient tests.
TADD LAZARUS: And I certainly do remember those days.
ANJALI SARKAR: That brings us to the end of today's GEN Protocols Expert Exchange. Thank you, Dr. Lazarus, for a very illuminating discussion. A reminder to all scientists and viewers in our audience, GEN Protocols is open for submissions. And we welcome your protocols in all aspects of biotechnology. This is Anjali Sarkar. Until next time, good luck in your research and goodbye from all of us at GEN Protocols. [MUSIC PLAYING]
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