The Medical Innovation Podcast - Detecting cancer's chaos with fragmentomics - DELFI 封面

Detecting cancer's chaos with fragmentomics - DELFI

Detecting cancer's chaos with fragmentomics - DELFI

本集简介

In this episode, we speak with Susan Tousi, CEO of DELFI Diagnostics and former Chief Commercial Officer at Illumina, about using fragmentomics and AI to detect cancer through a simple blood draw. Susan explains how Delfi's whole-genome approach analyzes the structural chaos of tumor-derived DNA rather than hunting for specific mutations, dramatically reducing cost while maintaining sensitivity. We discuss their first product, First Look Lung, which achieves 75% sensitivity for stage one lung cancer, and how the platform can expand to detect the seven deadliest cancers using the same laboratory workflow with different AI algorithms.

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Speaker 0

欢迎回到《医疗创新播客》。

Welcome back to the Medical Innovation Podcast.

Speaker 0

我们现在在健康峰会现场,非常荣幸能邀请到Delfi Diagnostics的首席执行官苏珊·图西。

We're at Health, and we have the privilege to be speaking with Susan Tousi, the CEO of Delfi Diagnostics.

Speaker 0

苏珊,很高兴你能来。

Susan, really great to have you.

Speaker 0

我们特别想听听你的经历,你是怎么来到Delfi的?

We'd love to hear a little bit about your background and how you came to Delfi.

Speaker 1

能来这儿我很高兴。

It's a pleasure to be here.

Speaker 1

谢谢你们的邀请。

Thanks for inviting me.

Speaker 1

简单说说我的背景。

A little bit about my background.

Speaker 1

我最初是在科技行业起步的。

I started my career in the tech world.

Speaker 1

我家族世代行医,家里有很多医生,我父亲就长期从事这一行。

I come out of a long line of medical doctors, have a lot of doctors in my family, including my father, who practiced for many years.

Speaker 1

我一直觉得,守护健康、早发现疾病、关心社区和病人,是最崇高的使命。

I always thought that taking care of people's health and finding disease early and caring for community and caring for patients was the highest order calling that you could have.

Speaker 1

虽然我一直对这个方向很感兴趣,但我没打算像父亲和家人那样,长时间待在医院里,一个病人一个病人地看。

So I was always interested in that, but I didn't see myself spending as much time in a hospital and, know, seeing kind of one patient at a time as my father and many people in my family did.

Speaker 1

事实上,我更被科技吸引。

In fact, I was really drawn to technology.

Speaker 1

我天生是个乐观派。

I was always an optimist.

Speaker 1

我一直相信,科技终将改变世界。

I always thought that technology was going to change the world.

Speaker 1

上学时,有些老师让我对用数学和科学解决工程问题充满热情,觉得这些能惠及广大人群,而不仅仅是一个个单独的病人。

I had teachers in school who got me excited about putting math and science to work in solving engineering problems and that those would be massively impactful to populations of people and not just, you know, an individual at a time.

Speaker 1

所以,这种想法特别打动我——通过创造新东西,真正让社会变得更好。

And so that notion was really, you know, compelling to me that you could invent things that could, you know, change society basically for, you know, for the better.

Speaker 1

于是我投身科技行业,开始学习工程。

And so I went into tech and I started studied engineering.

Speaker 1

我的职业生涯是从惠普开始的。

I started my career at HP.

Speaker 1

那时候惠普还由比尔·休利特和戴夫·帕卡德掌管,公司秉承着‘惠普之道’的价值观。

It was like the time when HP was still run by Bill Hewlett and Dave Packard and was a company that was found on the values the HP way.

Speaker 1

比如尊重个人,追求技术以造福社会。

So it was like respect for the individual, technology for the sake of betterment of the community.

Speaker 1

后来他们成了杰出的慈善家。

They went on to be great philanthropists.

Speaker 1

公司运作方式就是讲究实干精神,鼓励创新。

I mean, they're really the way the company was run, meritocracy, you know, inventing things.

Speaker 1

我特别喜欢这种氛围。

And I love that.

Speaker 1

充满抱负,乐观向上,还特别注重回馈社会。

And it was very ambitious, optimistic, kind of giving back.

Speaker 1

当工程师起步的地方再好不过了,特别适合学习如何成为一名工程师和创新者。

Great place to start as an engineer, great place to learn how to be an engineer and an innovator.

Speaker 1

我在那儿度过了十年美好的时光。

And I spent ten glorious years there.

Speaker 1

我真正学会了如何发明和创造东西。

I really learned how to invent things and build things.

Speaker 1

其实我还待了几年欧洲,帮忙建立我们在那里的一个部门。

I spent a few years in Europe actually helping to build one of our divisions there.

Speaker 1

我丈夫也在那儿,一切都特别棒。

My husband there was it was great all around.

Speaker 1

后来我对互联网热潮特别感兴趣。

And from there, I I was kind of excited about what was going on in the .com world.

Speaker 1

我就去了家初创公司。

I went to a startup.

Speaker 1

那其实是一家惠普和柯达的合资企业。

It was actually a joint venture between HP and Kodak.

Speaker 1

初创公司未必成功,但我学到了很多,比如怎么高效地争取资源、怎么发明知识产权,还有怎么跟投资人谈判。

Startups don't work out, but I learned a lot about how to be industrious about how do you get resources and how do you invent IP and negotiate with investors.

Speaker 1

总的来说,这段经历非常宝贵。

It was a great experience overall.

Speaker 1

后来,我被柯达挖走了。

But from there, I was recruited into Kodak.

Speaker 1

他们请我来帮忙打造数字技术,而这家公司虽然底蕴深厚,却没能顺利转型到数字领域。

And I was recruited to come help build the digital technologies in a company that had greatness, but didn't make the turn to digital.

Speaker 1

我在那里负责开发一些新的数字成像技术,包括数字打印和彩色成像,待了八年。我们从柯达实验室的基础做起——那里主要是化学和色彩科学,但当时他们几乎不做消费类产品,顶多就是相机,还没进入数字消费产品的领域。

And I was there to build some of the new digital imaging technologies, digital printing, color imaging, and had a eight year stint at Kodak where we developed the core technologies actually starting with what was at Kodak Labs, which was really a lot of chemistry, a lot of color science, but they didn't really do a lot of consumer products at the time, you know, beyond kind of the cameras, they hadn't gotten into the digital consumer products.

Speaker 1

所以我有八年时间主导了这个方向,之后我又回去拿了MBA,成了这个部门的总经理。

So I had an opportunity to kind of lead that for eight years, went back and got my MBA, became the general manager of that division.

Speaker 1

我们真的从零开始,靠着数字技术,建起了一项年利润五亿美元的业务。

And, you know, we really built kind of a $500,000,000 profitable business from scratch, from kind of starting with the digital technology.

Speaker 1

再后来,我越来越想了解医疗健康领域到底在发生什么。

From there, I started, you know, really feeling that I wanted to know what was going on in healthcare.

Speaker 1

我一开始避开医疗技术,是因为觉得它进展得太慢了。

The reason that, you know, I steered away from the technology behind healthcare initially was that it seemed to move really, really slowly.

Speaker 1

我想投身于节奏快、前沿的东西。

And wanted to, you know, kind of be on something that was fast paced and cutting edge.

Speaker 1

后来我接触到了因美纳公司。

I got introduced to Illumina.

Speaker 1

在因美纳,他们对基因测序能揭示人类生物学中许多未知领域充满雄心。

And at Illumina, you know, they were really ambitious about what genomic sequencing was going to do to like shed light on a lot of what we didn't understand in human biology.

Speaker 1

我见到了首席执行官杰伊·弗拉特利,他用iPad给我展示了他的基因组,跟我聊个性化医疗,说只要理解每个人的基因差异,就能更早发现疾病、精准诊断、预防复发。

And I met the CEO, Jay Flatley, who showed me his genome on an iPad and like, you know, talked about personalized medicine and how like understanding kind of the variance of an individual was not only going to allow us to like find disease earlier, diagnose or treat it properly, look for recurrence.

Speaker 1

就是我们现在看到的这些进展。

So all the things we're seeing happening.

Speaker 1

但那是2012年的事了。

But now this was in 2012.

Speaker 1

问题是,2012年测一个人的全基因组,成本还超过十万美元。

And the problem was that, you know, sequencing human genome in 2012 costs more than a $100,000.

Speaker 1

当时已经有数万个基因组被测序了,但成本实在太高了。

Know, tens of thousands of genomes had been sequenced, but, you know, it was really expensive.

Speaker 1

那是一种非常专业、主要面向科研人员的技术。

It was very kind of specialized technology for researchers.

Speaker 1

后来他们请我来帮忙扩大这项业务。

And I was brought in to kind of help expand that.

Speaker 1

我被聘入公司,担任产品开发负责人。

I was brought in, I became the head of product development for the company.

Speaker 1

我带领超过两千人的团队,花了十年时间开发所有测序平台、核心试剂、核心检测方法、临床诊断测试以及肿瘤治疗方案选择系统。

I managed the more than 2,000 people who developed for a decade all of the sequencing platforms, core reagents, our core assays, our clinical diagnostic tests, and IPT, therapy selection.

Speaker 1

那段经历太棒了。

It was fantastic.

Speaker 1

最后三年,我担任公司的首席商务官。

And for the last three years I was there as chief commercial officer.

Speaker 1

我带着我们研发的这些技术,走进了全球155个国家的客户手中。

I got to take all those, you know, technologies we created out to customers in a 155 countries.

Speaker 1

我特别喜欢我当时在做的事。

I loved what I was doing.

Speaker 1

我亲眼见证了基因测序从十几万美元一路降到不到十万美元的全过程,真是令人振奋。

I felt like I had seen a lot of the glory of, like, genomic sequencing go through a $100,000, a 100.

Speaker 1

我越来越想靠近患者,真正帮到他们。

And I got really excited about getting closer to patients.

Speaker 1

那么,面对现在的基因技术,我们该怎么做?怎么才能用它让患者的生活更健康、更有质量?

And so what do we do with this genomic technology and now, and how can we use it to improve the lives of patients and healthier lives?

Speaker 1

这就引出了我现在的公司——Delfi,我们的使命是通过广泛可及的早期筛查,让癌症不再那么致命。

So that brings me to Delfi and Delfi's mission is to make cancer less deadly through widely accessible early detection.

Speaker 1

我从去年年初就加入Delfi了,快两年了,这段经历真的太棒了,说也说不完。

And I've been Delfi since early last year, so almost two years, I don't know, two years, and it's been a fantastic ride, and, you know, I'd just tell you more about it.

Speaker 2

这真是一段引人入胜的历程。

That's a fascinating, very interesting journey.

Speaker 2

我完全能理解你的感受。

I can definitely relate, though.

Speaker 2

到目前为止,我的人生路走得很直,没什么大转弯。我觉得正是你刚才说的这一点特别吸引我——医疗创新能一次影响的不是一个人,而是成千上万甚至上百万人。

I have made a lot less twists and turns in my life so far, and I think one of the things that really draws me to medical innovation is sort of what you said, the ability to impact not just one life at a time, but thousands or millions at a time.

Speaker 2

过去,医疗行业就像一部慢动作电影,到处都是阻碍发展的障碍,但这些年情况正在改变,医疗创新的速度越来越快,涌现出大量新技术,极大地提升了我们干预患者、彻底改变诊疗方式的效率。

And it used to be that healthcare was a very slow movie industry, and there's a lot of roadblocks to growth, but that's changing over time, and innovation in healthcare is getting a lot faster, and there's lots of new solution technologies that are really elevating how fast we can impact patients and revolutionize how we care for patients.

Speaker 2

看到像你这样既有专业背景、又能带领团队的人转战生物科技和医疗领域,真正推动创新,真的特别令人振奋。

So, it's really great to see people like you who have the expertise and sort of the ability to lead teams transition over to biotech and healthcare and really help drive that innovation.

Speaker 2

不过我特别想多听听关于Delfi的细节,你们用的是什么技术?具体是怎么实现更早发现癌症的?又怎么帮助患者尽早战胜癌症的?

But I would love to hear more about Delfi specifically, the technology that you're working with, and how you go about actually detecting cancer earlier and hopefully helping patients, you know, beat cancer earlier.

Speaker 1

我特别喜欢聊Delfi,因为我觉得我们正站在最前沿,属于革命性的新一代血液早筛技术。

I love talking about DELFI because I really feel like we are on the cutting edge, kind of the revolutionary next generation technology of blood based early detection.

Speaker 1

我们的检测和之前那些技术不同,一些大型上市公司做的血液检测诊断,成本太高,依赖基因测序。

And the way our test is different is that the tests that preceded us, some of the large public companies are doing diagnostics based on blood based testing, Genomic sequencing costs more.

Speaker 1

所以他们一开始采取的是更聚焦、更有限的方案。

So they started with much more of a targeted approach.

Speaker 1

而Delfi的初衷是利用游离DNA的全基因组信息,结合所有可用的生物线索,仅凭一管血,就能在癌症最早期就把它找出来。

And Delfi came on the scene with an ambition to use the whole genome of cell free DNA all the biological context that you can use to find cancer at the earliest stages from a simple blood draw.

Speaker 1

我们取一管血样。

And so we take a sample of blood.

Speaker 1

其实就是一次抽血,六管血而已。

It is literally one blood draw, six tubes of blood.

Speaker 1

虽然还是只抽一次血,但我们会把血浆分离出来,从中提取所有游离DNA的信息。

It's just still one blood And we distill from it, spin down the plasma, we take from that all of the information that is coming from cell free DNA.

Speaker 1

这意味着,当你体内长了肿瘤,哪怕还处于早期阶段,也会有细胞脱落进入血液循环。

What that means is that, you know, when you have a tumor that's growing in your body, even at the earliest stages, it's, you know, shutting off cells that would be present in the bloodstream.

Speaker 1

我们不只关注游离DNA里的某些特定片段或突变位点,而是把所有碎片信息都拿过来分析,这就是所谓的片段组学。

And so by not only looking at certain components or usually mutation sites from that cell free DNA, we take all of the information, that's kind of fragmentomics.

Speaker 1

我们会分析每一个DNA片段的完整基因组信息。

We look at the entire fragment, the genomic information in all those fragments.

Speaker 1

因为癌症特别混乱,会出现拷贝数变化、扩增、缺失、染色体臂的增加或减少。

Because cancer is so chaotic, you're getting copy number variation, amplifications, deletions, chromosome, arm gains, losses.

Speaker 1

当我们全面分析这些游离DNA的基因组信息时,就能发现一些只有癌症才有的特征,而良性结节是不会出现这些信号的。

When you look across the entirety of the genomic information from this cell free DNA, you get kind of hallmarks of, you know, these signatures that are only present in cancer, aren't present in kind of benign nodules.

Speaker 1

正因如此,我们才能在癌症早期——比如一期——就实现极高的检测灵敏度。

It's because of that large signal to noise base that we get that we get very high sensitivity at the earliest stages of cancer, stage one.

Speaker 1

于是我们把这项技术开发了出来。

And we took that technology.

Speaker 1

它是基于全基因组的,所以能适用于任何类型的癌症。

It's a whole genome based, so, you know, it can apply to any cancer.

Speaker 1

不是只针对某些特定的基因突变。

It's not just, like, particular mutations.

Speaker 1

对某些癌症可能更适用,对其他癌症则没那么突出。

It might be more relevant for one cancer or another.

Speaker 1

这本质上是一种平台型技术。

It really is platform technology.

Speaker 1

但正因为它的早期灵敏度这么高,我们决定聚焦一种目前缺乏有效手段、死亡率又高、真正能挽救生命的癌症——那就是肺癌。

But because of this high early stage sensitivity, we wanted to go after a cancer that was, really unaddressed, that had a high mortality today and that we could really change lives, like save lives, and that's lung cancer.

Speaker 1

因此,我们推出的首款检测产品是一种基于血液的LDT检测,已获得FDA的突破性认定,目标是最终推向市场。

So our first test that we launched as a blood based LDT and which we got breakthrough designation from the FDA to take all the way to an IBD, is for lung cancer detection.

Speaker 1

所以,我们推向市场的检测产品叫First Look Lung。

And so our test that's on the market is called First Look Lung.

Speaker 1

它的早期敏感度很高,能发现75%的早期肺癌病例。

It has high, like 75% stage sensitivity for finding lung cancer here.

Speaker 1

很多人并不知道,肺癌其实是致死率最高的癌症。

Most people don't realize, I mean, lung cancer is the deadliest cancer.

Speaker 1

每五个癌症死亡病例中,就有一个是肺癌。

One in five cancer deaths is from lung cancer.

Speaker 1

每年有22.6万人被诊断出患有肺癌。

Two hundred and twenty six thousand people diagnosed with lung cancer every year.

Speaker 1

每年有12.5万人死于肺癌。

Hundred and twenty five thousand people die of lung cancer every year.

Speaker 1

它的致死人数是结直肠癌的两倍半。

It takes two and a half times the number of lives of colorectal cancer.

Speaker 1

我们经常听到关于结直肠癌的讨论,好在筛查率已经提升了。

We've heard a lot about colorectal cancer and thankfully screening rates are up.

Speaker 1

但肺癌虽然夺走的生命是结直肠癌的两倍半,筛查率却依然很低。

But for lung cancer, although it takes two and a half times the number of lives of colorectal cancer, screen rates are just very low.

Speaker 0

没错。

Right.

Speaker 1

这真是个悲剧。

It's a tragedy.

Speaker 1

筛查率大概只有百分之十左右。

Screening rates are like ten percent.

Speaker 1

最好的数据也不过在百分之十五上下。

The best numbers you find are like in fifteen percent range.

Speaker 1

大多数人根本没去做筛查。

So the majority of people are not getting screened.

Speaker 1

但我们完全可以改变这个局面。

And we can make a difference.

Speaker 1

你是不是觉得,大多数人觉得肺癌一确诊就等于判了死刑?

And you think most people consider a diagnosis of lung cancer to be so deadly.

Speaker 1

但实际情况是,如果能早期发现肺癌,尤其是第一期,十年生存率能达到百分之七十三。

But the reality is when you find lung cancer early, when you find it at stage one, the ten year survival rate is seventy three percent.

Speaker 1

所以这种癌症其实是可以治好的。

So it's very survivable.

Speaker 1

我的意思是,肺癌的治疗手段这些年进步很大,尤其是免疫疗法,已经显著提升了生存率。

I mean, this is a cancer that has had so much therapy development and, you know, we know the immunotherapies that have really impacted kind of survival rates.

Speaker 1

不过这些疗法的效果,最好的情况还是在癌症早期发现的时候。

But, you know, those are best when you find the cancer early.

Speaker 1

这正是我们关注的重点。

That's what we're focused on.

Speaker 1

因此,肺癌的早期检测是我们首要的方向,目前进展已经相当不错了。

So lung cancer detection is our first indication and we're pretty far along.

Speaker 1

我们已经有三个临床试验完全完成了入组。

We actually have three clinical trials fully enrolled.

Speaker 1

我们刚刚公布了欧洲一项试验的初步结果。

We read out top line on a European trial.

Speaker 1

去年年底,我们已经纳入了七千五百名患者。

We had 7,500 patients late last year.

Speaker 1

明年我们就要启动关键性临床试验,也就是FDA的那项研究。

And we're gearing up for our seminal trial next year, which is our FDA trial.

Speaker 1

这项试验叫Cascade Lung,我们会对这些患者进行一到两年的随访。

It's called Cascade Lung, and we'll have one and two year follow-up feed on those patients.

Speaker 0

是的。

Yeah.

Speaker 0

太惊人了。

Wow.

Speaker 0

这真的非常了不起。

It's really incredible.

Speaker 0

我的临床兴趣主要在肿瘤领域,所以这个项目特别吸引我。

I think my clinical interest is in oncology, and so this is super fascinating.

Speaker 0

现在肺癌筛查的主流方法是低剂量CT,但它的准确性其实并不理想,就像你提到的,很多肺结节其实是良性的,只能先观察一段时间。而这种基于血液DNA的技术,能更好地区分良性病变和真正的癌症。再想想检查的便利性——抽血和做扫描,哪个更简单,答案很明显。

Think when you think about the current paradigm of lung cancer screening, it's low dose CT scans that don't have the best data in terms of detecting cancer particularly, because like you mentioned, oftentimes there are lung nodules that are benign that oftentimes will just follow for a period of time, but this blood based technology through the DNA would be able to differentiate things that might benign versus things that are actually cancer, and when think about the difficulty of the exam, like whether a blood test versus having to go in for a scan, I think it's pretty clear what's easier as well.

Speaker 0

所以这是一种更简便的检测方式,取代了目前的筛查标准,而且还有扎实的数据支持。

So it's an easy modality replacing, I guess, what a current paradigm is in screening while also having great data backing it.

Speaker 0

这确实是一个非常有意思的方向。

So it's a really fascinating approach.

Speaker 1

是的,谢谢。

Yeah, thank you.

Speaker 1

我们跟合作的全科医生们交流时也发现,那些现在开这项检测的医生们都是这么看的。

I mean, we see it with the primary care docs that we work with, the providers who are prescribing the test today.

Speaker 1

他们认为,低剂量CT确实被证明能挽救生命。

Their view, I mean, low dose CT scanning is, I mean, it's shown to save lives.

Speaker 1

但问题是,真正去做检查的人太少了。

And the problem is that people just aren't getting it done.

Speaker 1

再说到可及性,首先,这项工作通常落在全科医生或者呼吸科医生身上,而他们本来就忙得不可开交。

And when you think about accessibility, I mean, first of all, the burden comes on the primary care docs typically or pulmonologists, and they're already very busy.

Speaker 1

所以还得专门去追着病人,催他们来做筛查。

So chasing a patient to make sure that they go and get a screen done.

Speaker 1

在这种情况下,低剂量CT筛查被用于多种用途,比如在手术前帮患者定位癌症。

And in this case, I mean, the early detection LDCTs are used for a lot of things and they're used for patients to locate the cancer before surgery.

Speaker 1

所以它在筛查项目里并不总是优先考虑的选项。

So they're not always on the top of the priority list for a screening test.

Speaker 1

而且患者通常也不是在诊疗现场就能做这个检查。

And patients often, it's not point of care.

Speaker 1

他们得提前预约时间。

Like they have to schedule appointment.

Speaker 1

还得请假一天去检查。

They have to take a day off work.

Speaker 1

还得有人开车送他们去。

Someone has to drive them.

Speaker 1

对很多人来说,这实在不太方便。

So it's just not convenient for everyone.

Speaker 1

并不是人人都能轻松接触到这项检查。

It's not accessible to everyone.

Speaker 1

我们特别喜欢听First Look Lung的医疗提供方反馈。

And we love hearing from kind of our providers for First Look Lung.

Speaker 1

他们说,我们诊所里就有抽血服务。

They say, Hey, we have phlebotomy in our offices.

Speaker 1

我们确保患者在离开诊所前就把血抽了。

We just make sure the patient gets their blood draw before they even leave the office.

Speaker 1

而且你说得对,如果我们的检测结果是阴性,患者患肺癌的概率不到千分之二,他们就会说:明年再来做一次筛查就行。

And, and to your point, you know, if our test comes back negative, ninety nine point eight percent chance of the patient doesn't have lung cancer, they just say, come back next year, narrow screen.

Speaker 1

如果结果是阳性,患者实际通过LDCT发现肺癌的可能性高出五倍,准确说是5.2倍。

If it's positive, the patient is five times more likely, five point two times more likely to actually find lung cancer in an LDCT.

Speaker 1

我们发现,这样一来,后续检查确实能跟上。

And what we're finding is then they do get the follow-up.

Speaker 1

他们的医生也会主动确保患者完成后续检查。

And their providers make sure they get the follow-up.

Speaker 1

所以后续的跟进都在顺利进行。

And so the follow-up is happening.

Speaker 1

LDCT和我们检测结果结合后的预测价值翻了一倍。

The, you know, predictive value of the LDCT and the kind of combination of that and the positive on our test is doubled.

Speaker 1

这样一来,假阳性的情况就减少了。

So, you know, you have fewer false positives as a result.

Speaker 1

整个就医体验也更好了。

So it's just a better patient experience.

Speaker 1

最重要的是,一定要确保大家都能接受筛查。

And most importantly, just make sure that people get screened.

Speaker 1

当然。

Sure.

Speaker 1

我想,这正是我们的信念。

And that's, I think that's what we believe.

Speaker 1

我们坚信筛查的重要性。

We believe in screening.

Speaker 1

我们坚信在癌症早期阶段就要有高灵敏度的检测。

We believe in high sensitivity at the earliest stages of cancer.

Speaker 1

筛查的核心就是这个。

That's what screening is all about.

Speaker 1

别漏掉任何可能患有癌症的患者。

Don't miss any patients who potentially have cancer.

Speaker 1

我们非常期待能一路推进到获得FDA批准,确保医保覆盖,并让所有患者都能用上这项技术,先从美国开始。

We're really excited to see this all the way through to getting FDA approval, making sure it's reimbursed, making sure it's all available to all patients, starting in The US,

Speaker 2

但我们的目标是全球范围。

but our ambitions are global.

Speaker 2

这确实令人振奋。

That's really exciting.

Speaker 2

你说得对,肺癌的筛查率太低了。

To your point, lung cancer is very under screened.

Speaker 2

依我的经验,除非是长期吸烟者,否则人们通常不会主动筛查,这跟结直肠癌不一样——到了一定年龄,医生都会建议或要求你做检查。

I think, in my experience, people only screen when there's a reason to if they're a chronic smoker, unlike colorectal cancer, which you hit a certain age and you're pretty much automatically required to do it, or suggested to do it.

Speaker 2

所以,这项技术的需求非常大,如果能不用做CT扫描就能实现筛查,那将是一个巨大的突破。

So, it's a huge need for it, making it more accessible without needing to go to do that CT scan would be a huge sort of game changer.

Speaker 2

我想了解一下,你们对这个肺癌检测产品的市场推广计划是怎么设想的?

I'm curious, how do you envision the go to market plan for this lung cancer test specific list?

Speaker 2

当然,你们未来还有其他检测项目,但有没有考虑把它纳入每年体检的常规血液检查项目?

And obviously, you have other tests down the road as well, but do you envision it becoming part of the standard blood panel you get your annual checkup?

Speaker 2

或者你们整体的规划是怎样的?

Or what's sort of the plan?

Speaker 1

是的。

Yeah.

Speaker 1

对。

Yeah.

Speaker 1

我们觉得整个医疗行业正在向数字健康方向发展。

I mean, we we see that the world is moving towards digital health.

Speaker 1

事实上,我们现在就在参加一个相关会议。

And in fact, we're at a conference.

Speaker 1

这根本不是什么数字健康,而是规模越来越大,人人都在谈人工智能、数字化和电子病历。

This is not digital health, and it keeps getting bigger, and, you know, everyone's talking about kind of AI and digitization and electronic health records.

Speaker 1

我们要瞄准 puck 将要到达的地方。

We want to shoot where the puck is going.

Speaker 1

所以我们在推广这项检测时,要考虑如何融入现有的数字工作流程。

And so when we think about commercializing this test, how do we integrate into the digital work flow that is already there?

Speaker 1

我们注意到,就连现在已经在开我们检测的社区医院,也都很有前瞻性。

And we see this, I mean, even in community hospitals that are prescribing our tests today, they're forward thinking.

Speaker 1

他们在思考怎么把这些流程自动化。

They're thinking about how do we automate these things?

Speaker 1

怎么确保忙碌的医生能通过电子病历收到提醒,及时为患者推荐合适的筛查项目。

How do we make sure our busy docs are like, you know, that they're, you know, just pinged through health records to offer the right diagnostic screening for a patient?

Speaker 1

不能指望医生记住所有细节。

They can't be expected to remember everything.

Speaker 1

所以我们现在首先发现,在这个案例中,吸烟史是关键,因为我们最初的目标人群是那些有吸烟史的人,美国这方面的患者就有两千万,我们能立刻服务到他们。

And so, you know, we're working, first of all, we're finding that, in this case, smoking history, because the initial population we're starting with are people who have a smoking history, that's twenty million patients in The US that, we can immediately serve.

Speaker 1

顺便说一句,我们的模型显示,如果这项检测的普及率能达到今天乳腺癌筛查或结直肠癌居家筛查的水平,仅在美国,每年就能挽救一万人的生命。

By the way, we have modeling that shows that if our test is adopted to the rate that mammography is done today or home CRC screening is done today, that we can save ten thousand lives a year in The US alone in this population.

Speaker 1

我们会确保这个检测项目与医疗系统紧密合作,目前我们已经和一些系统建立了合作关系,接下来还会进一步扩大合作范围。

So we would make sure that this test, working with health systems, and we're already partnered with a number of them, but we would expand that.

Speaker 1

通过与医疗系统协作,我们会把我们的检测流程无缝整合进他们的筛查工作流程中。

Working with health systems, we would automate our tests into their workflow for screening.

Speaker 1

我们目前正在和他们紧密合作。

And we are working with them.

Speaker 1

我们发现,到现在为止,他们依然没有有效识别出这些患者。

We're finding this today that once again, they're not identifying the patients.

Speaker 1

吸烟史在电子健康记录里并没有被常规记录下来。

The smoking history isn't routinely captured in the EHR.

Speaker 1

他们是有意愿去改变的。

And they're motivated.

Speaker 1

他们非常希望推动这项改进。

They're motivated to change that.

Speaker 1

此外,医疗系统和支付方也意识到,肺癌筛查的质量指标和使用指标即将出台,他们都想提前布局。

And also, think health systems and payers are seeing that quality measures, use measures, quality measures for lung cancer screening are on the horizon and they want to get out ahead of it.

Speaker 1

归根结底,我们的目标是服务患者、改善生活,而早期发现癌症、采用更精准有效的治疗,能带来巨大的成本节约。

And ultimately, I mean, want to serve patients, improve lives, and there's a massive cost savings, by actually finding cancer early, having more targeted, therapy that's effective.

Speaker 1

与其等到生命最后几个月才用那些副作用极大的治疗手段,那时候效果也差得多。

And, you know, instead of, like, the very heavy therapy that happens in the last months of life, and RMA is not nearly as effective.

Speaker 1

这就是我们打算商业化的方式。

So that's how we intend to commercialize.

Speaker 1

我们目前先从这个群体开始。

We, you know, are starting with this population.

Speaker 1

我们经常被问到,几乎每天都能听到有人讲述自己或亲人患肺癌的故事,而这些人根本从不吸烟。

We get asked all the time, and not a day goes by that I don't hear someone's story about lung cancer in a patient that or a loved one that has never smoked.

Speaker 1

我觉得,未来我们会听到越来越多这样的故事。

I think we're all, you know, going to hear more stories about that.

Speaker 1

从未吸烟的人群中,肺癌的发病率实际上正在上升。

And the rate of lung cancer being found in people who've never smoked is actually increasing.

Speaker 1

因此,我们看到了扩展适用人群的机会——不仅限于目前美国预防服务工作组指南涵盖的戒烟者,还包括从不吸烟的人群,因为通常需要权衡风险与收益。

And so we see the opportunity to expand the intended use beyond kind of the former smokers, which are covered today by US Preventive Services Task Force guidelines, Two, never smokers because usually there's a risk benefit ratio that's looked at.

Speaker 1

在做放射性检测时,你得把接受诊断测试的患者范围收窄一些。

And when you're in a radiation test, you have to then kind of narrow the patients that you're providing the diagnostic test to.

Speaker 1

但这里完全没有风险。

But there's no risk here.

Speaker 1

只需要抽一次血而已。

There's just one blood draw.

Speaker 1

所以我们觉得,这个检测完全可以推广到更广泛的人群。

So we see a real opportunity to expand kind of beyond the current population.

Speaker 1

我们还希望这个检测能走向全球。

And then we really want to see this test kind of globalized.

Speaker 1

许多国家的肺癌发病率都非常高。

Lung cancer is at very high rates in many countries.

Speaker 1

肺癌在大多数发达国家是头号癌症杀手,在多数国家也位列前茅。

Lung cancer is the number one cancer killer in most developed nations and amongst the top in in most countries.

Speaker 0

是的。

Yeah.

Speaker 0

这其实很有意思,因为你们整个技术都是基于血样中的片段组学平台,用它来做无创检测。

And it's really interesting because you're basing this all off of the fragmentomics fragmentomics platform that you're using as a as a modality in blood based assessment.

Speaker 0

我看了你们之前发表的一些论文,发现你们还能用这个方法监测已经确诊的患者,比如肺癌患者,通过定期抽血就能判断病情是否进展,或者有没有复发的风险,这类应用很实用。

And so I was looking at some of the other papers that you published and like one of the things seems like you can use it in monitoring the current diagnosis, like if someone has lung cancer already, can use it as a maintenance blood draw that you can see to see progression or like risk of remission and things like that.

Speaker 0

我觉得这个方向特别有前景。

And I think that's a really exciting application.

Speaker 0

还有你之前提到,如果这个检测结果呈阳性,就能提高CT扫描阳性的可能性。

And I also think about, you mentioned earlier, just if a test comes back positive, it increases the likelihood that a CT scan is positive.

Speaker 0

也就是说,它能给医生和患者一个更强的理由去安排CT检查。

So it's like that, you know, kind of impetus to get, like there's a more importance in getting that scan.

Speaker 0

但很多癌症目前还达不到这种风险与收益的平衡,做筛查并不划算。

And there are a lot of cancers where that risk to benefit ratio isn't high enough to justify a scan.

Speaker 0

比如胰腺癌,根本就没有常规的影像筛查手段。

Like I think about pancreatic cancer, there's no like imaging that people are getting to prevent it.

Speaker 0

所以我想问的是,你们有没有考虑过用片段组学去发现其他癌症的早期风险信号,比如胰腺癌,或者其他类型的癌症,从而推动更早的进一步检查?

So I guess my question is, you looking at other cancers where you can look at fragmentomics to suspect maybe there's an increased risk of pancreatic cancer or a different type of cancer to then justify further exploration into initial stages of disease?

Speaker 1

是的,这些问题都很好。

Yeah, it's all very good questions.

Speaker 1

我们此刻正参加一个关于人工智能与生物学结合、推动医疗变革的会议。

And, you know, we're sitting here at a conference that's about like AI coming together with, you know, biology and like changing healthcare.

Speaker 1

正如我提到的,我们是一家面向未来的公司。

And we are, as I mentioned, we're kind of a next generation company here.

Speaker 1

我们之所以能提取出信号,并实现高灵敏度,完全得益于人工智能。

The reason we can derive a signal and derive a high sensitivity signal is because of AI.

Speaker 1

也就是说,正是我们对大量生物样本进行训练后所开发的AI算法带来了这一成果。

I mean, it's the AI algorithms that we've applied to massive amount of like training on these biological samples.

Speaker 1

我们的生物样本库尤其重要,其中包含了大量早期癌症样本,这是我们公司重点投入的宝贵资源。

Our biobank alone, which has very high complement of stage one cancers that we've trained on, is a really important asset that we've invested in as a company.

Speaker 1

而且,正如我所说,我们的检测基于全基因组测序,因此也能应用于其他癌症。

And our test, because it's whole genome, as I mentioned, you know, serve other cancers.

Speaker 1

我们已经通过科学研究和论文证实了这一点,你可能也见过,我们的技术在七种致死率最高的癌症中都有效,包括胰腺癌。

We've demonstrated, we have scientific publications, as you know, sounds like you may have seen, in the seven deadliest cancers, including pancreatic cancer.

Speaker 1

我们已经在肝癌和卵巢癌上取得了成果。

We have shown results in liver cancer and ovarian cancer.

Speaker 1

厉害的是,所有检测都用同样的实验室流程和全基因组方法,只是用了不同的分类器和针对不同数据训练的算法。

And the beauty is it's all the same lab workflows, all the same whole genome approach, but it's different classifiers, different algorithms trained on, you know, different data.

Speaker 1

你可以想象,我们的检测技术未来能应用到全国各地乃至全球的多个站点,我们只需要更换不同的算法就行。

And so you can foresee that, you know, our tests could exist in many sites around the nation, around the world, and we are then just applying different algorithms.

Speaker 1

我们就像一家软件AI公司,把不同的算法应用在这些生物数据上。

We're like a software AI company applying different algorithms to that biological data.

Speaker 1

这一点同样成立。

And the same is true.

Speaker 1

至于监测用途,正如你提到的,目前我们的产品仅限科研使用。

The monitoring application, as as you mentioned, We have, it's a research use only product.

Speaker 1

我们主要为制药公司提供检测服务,用我们的平台来监测治疗反应。

We run the samples for primarily pharma companies, using our platform to look at therapeutic response monitoring.

Speaker 1

这主要针对转移性癌症,也就是三期或四期的患者。

This is for kind of metastatic disease, so patients in like stage three, stage four cancer.

Speaker 1

但我们已经证明,这种方法比目前用于治疗监测的影像技术更有效。

But we've shown that, you know, the approach is very effective and better than the imaging based techniques used today for therapeutic monitoring.

Speaker 1

而且,我们能提前很多个治疗周期就检测到变化。

And the, you know, the many cycles kind of we can detect that many cycles of treatment before.

Speaker 1

厉害的是,这套方法完全一样。

And the beauty of it is the same approach.

Speaker 1

成本很低,用的是简单的全基因组测序方案。

It's very low cost, simple whole genome approach.

Speaker 1

我们的技术基于人工智能分析全基因组数据,因此具备很强的可扩展性,不仅能用于其他癌症,还能贯穿癌症的整个过程——从早期筛查到治疗监测。

I mean, you know, the fact that our technology is based on AI applied to a whole genome data makes the approach scalable, applicable to other cancers, applicable in the cancer journey from like early detection all the way to therapeutic monitoring.

Speaker 1

而且它简单又便宜。

And it makes it simple and low cost.

Speaker 1

我觉得,如果检测费用动辄几千甚至上万美元,根本不可能在早期筛查或疾病监测这类大规模人群中真正普及开来。

I think, you know, this is something that we are really committed to, that these tests when they're in the thousands of dollars and multi thousand dollars, they really aren't going to make the kind of population scale impact that you need to make when you're talking about, you know, early detection or monitoring of disease.

Speaker 1

这些检测必须反复进行。

These are tests that have to be applied time and time again.

Speaker 1

我是说,在早期筛查的情况下,每年都要做一次。

I mean, in the case of early detection annually.

Speaker 1

你得对大量人群进行检测,才能发现那些隐藏的癌症。

And you have to test populations of people to find the cancer in some medicine.

Speaker 1

不能让任何人漏掉。

You can't let anyone slip through.

Speaker 1

所以,只有当成本合理,而且有良好的卫生经济学基础时,这事才可能实现——这正是我们一直全力关注的。

So it's only going to happen, I think, if the cost structure makes sense and there's kind of a health economic situation here, and that's, you know, something that we've been absolutely focused on.

Speaker 1

不过,我们对其他应用和技术确实非常兴奋,

But, yeah, we're really excited about the other applications and technology and

Speaker 2

还有其他类型的癌症。

the other cancers.

Speaker 2

想想看,在我这一辈子,以前连测完整个基因组都几乎不可能,现在却能从一滴血里就分析出来,有没有癌症的标志物。

It's crazy to think about how, like, in my own lifetime, it was barely possible to even capture the entire genome, and now you're able to do it from this one sample of blood and figure out, you know, are there markers for cancer?

Speaker 2

只用一支试管的血,就能判断这个人患癌的风险更高,然后安排CT检查,或者做其他合适的筛查。

And just use, you know, one vial of blood to identify this person's more likely to have cancer, let's get a CT scan, let's get them, you know, whatever is applicable screening.

Speaker 2

这真的很有意思。

That's really interesting.

Speaker 2

看到它发展得这么快,真的很惊人,而且你也能看出,还有更多应用场景。

It's amazing to see how fast it's growing, and as you see, there's so many more applications.

Speaker 2

肺癌只是开始,还有胰腺癌呢。

Lung cancer is just the beginning, there's pancreatic cancer.

Speaker 2

还有好多其他癌症,或者能用来早期筛查、帮助人们了解自身健康风险的应用。

There's so many other cancers, or applications that can be done to just get patients screened early and make them aware of what's likely with their health.

Speaker 2

是的。

Yeah.

Speaker 2

真的很棒。

It's really cool.

Speaker 2

我们马上就要结束了,我很好奇你们为什么取名叫 Delfi。

As we wrap up in the next couple of minutes, I'm curious about the name Delfi.

Speaker 2

这个名字是怎么来的?

Where did that come from?

Speaker 1

其实这个名字是我在接手机公司时沿用的,当时就被这种利用DNA片段的理念深深吸引,Delfi代表的是‘DNA片段评估用于早期干预’。

Well, I think it was, you know, the founding team I kind of took over from the founder of the company, but kind of fascinated by this use of fragments and you know how to really kind of bring that out in the name and it stands for DNA Evaluation of Fragments for Early Interception.

Speaker 1

读起来特别顺口。

It rolls off the dime.

Speaker 1

同时,它也巧妙地借用了古希腊德尔斐神谕的名字,但真正含义还是‘DNA片段评估用于早期干预’。

So it's also, you know, kind of play on the Oracle of DELFI, but DNA evaluation of fragments for early interception is kind of what it stands for.

Speaker 1

癌症信号其实就藏在血液里,我们通过分析这些片段,关键是保持它们的完整性,从整体生物学特征中提取癌症的线索。

And this beauty of, you know, the kind of cancer signal is right there in the bloodstream and that's, you know, and looking at these fragments and I mean, approach is really kind of keeping these fragments intact, looking at the entire biology of them to drive the cancer signal.

Speaker 1

再加上算法的进步、大规模计算资源的普及,这些因素结合起来,才让我们能以极低的成本,让每位患者都用得上这项技术。

And then thankfully, you know, the development of algorithms, the kind of access to large scale computing, I mean, all of these things come together in a way that's allowed us to do this and to do it at a very affordable cost that can be available to every patient.

Speaker 0

是的。

Yeah.

Speaker 0

非常感谢你,苏珊。

Well, thank you so much, Susan.

Speaker 0

和你聊天太棒了,我特别期待Delfi未来的发展,也期待CASCADE的演进,更期待肺癌筛查技术在未来几年的突破。

It's been incredible chatting with you, and I'm really excited to see where Delfi goes and how CASCADE evolves and just excited to see lung cancer screening evolve over the years.

Speaker 1

非常感谢。

Thank you so much.

Speaker 1

谢谢您,敬请期待。

Thank you and stay tuned.

Speaker 1

我们对即将出炉的结果非常乐观,这真的有望为众多肺癌患者带来根本性的改变。

We're very optimistic about the results to come and really, you know, changing the face of lung cancer for so many patients.

Speaker 2

谢谢。

Thank you.

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