Guardant Health (GH) and Exact Sciences (EXAS)

Disclaimer:

Our content is intended to be used and must be used for information and education purposes only. It is very important to do your own analysis before making any investment based on your own personal circumstances. You should take independent financial advice from a professional in connection with, or independently research and verify, any information that you find on our Website and wish to rely upon, whether for the purpose of making an investment decision or otherwise.

March 15th 2024

An article published in NY times on 3/13/24 titled “A Blood Test Shows Promise for Early Colon Cancer Detection” shared news about a blood test for colon cancer screening.

Let’s look at the results of this ECLIPSE trial published in NEJM:

This blood test missed 87% of advanced precancerous lesions which makes it less useful in early screening. There is also a trend in the data showing the blood test is less effective in detecting early stage cancers (the sensitivity for clinical stage I colorectal cancer was 55% while and sensitivity for clinical stage I, II, or III colorectal cancer was 81%).

While a colonoscope is able to visualize the precancerous polyps and remove them (performing diagnosis and treatment at the same time), the blood test seems to be detecting cancer but at a later stage. If I were the patient I would do the colonoscope. As a physician I would still recommend patients to get a colonoscopy, only when the patient is resistant to the ideas of performing colonoscopy I will recommend for the patient to get a fecal or blood test. Fecal test is more sensitive and more specific partly due to the sample being closer to the tissue (Per Blue-C trial, the next-generation Cologuard test has a sensitivity of 93.9% for colorectal cancer and specificity of 92.7% in a population of asymptomatic adults 40 years of age or older while ECLIPSE trial is conducted in a population of 45 years or old).

Now how much promise does it carry for the trial sponsor Guardant Health? It has to be FDA approved first and be reimbursable by insurance companies and government insurance plans such as Medicaid or Medicare and consumer or primary care physicians have to be willing to order the tests. The current major selling point for Guardant health’s blood based screening test is high patient compliance.

Exact Sciences published a trial in NEJM in 2014: in asymptomatic persons at average risk for colorectal cancer, it detected significantly more cancers than did FIT but had more false positive results. This test is called Cologuard with a cost of $581 to $681. Now 10 years later Cologuard revenue is about 2 billions annually with a trend to grow.

Of notice, Epi ProColon test made by a Germany company Epigenomics AG (FSE: ECX) was approved by FDA but was not granted Medicare payment. It cited the criteria for a blood-based screening test need to have both sensitivity greater than or equal to 74% and specificity greater than or equal to 90% in the detection of colorectal cancer compared to the recognized standard (accepted as colonoscopy at this time).

Whole body MRI

Whole-body MRI (WBMRI) is a diagnostic imaging technique that covers the entire body, providing detailed images of multiple organ systems and tissues. While WBMRI is not used as a routine screening tool for the general population, it has specific applications in certain clinical situations. Guidelines for the use of whole-body MRI may vary by country and professional organizations, but here are some common applications:

1. Multiple myeloma: WBMRI is often recommended for the initial staging of multiple myeloma and assessment of treatment response, as it can detect bone marrow involvement and bone lesions throughout the body.

2. Lymphoma: WBMRI may be used for staging certain types of lymphoma, including Hodgkin’s and non-Hodgkin’s lymphoma, and for assessing treatment response.

3. Metastatic disease: WBMRI can be useful for detecting metastases (cancer that has spread) from known primary tumors, especially when the primary cancer is known for producing diffuse metastatic patterns.

4. Bone metastases: WBMRI may be used to detect bone metastases from various primary cancers, such as breast, prostate, and lung cancer, as it provides high-resolution images of bone marrow and surrounding soft tissues.

5. Inherited tumor syndromes: WBMRI can be used for surveillance in patients with certain inherited tumor syndromes, such as Li-Fraumeni syndrome or von Hippel-Lindau disease, to detect early signs of cancer throughout the body.

6. Pediatric oncology: WBMRI may be used in pediatric oncology for staging, treatment response assessment, and surveillance due to its ability to provide comprehensive imaging without ionizing radiation exposure.

7. Inflammatory and autoimmune diseases: WBMRI can be used to assess the extent of certain systemic inflammatory or autoimmune diseases, such as vasculitis, sarcoidosis, and systemic lupus erythematosus (SLE).

8. Skeletal abnormalities: WBMRI may be used to evaluate the extent of certain skeletal abnormalities, such as Paget’s disease or fibrous dysplasia.

It is important to note that whole-body MRI should only be used when medically necessary, as determined by your healthcare provider. The appropriateness of WBMRI will depend on the specific clinical situation, the benefits of obtaining comprehensive imaging, and potential risks or limitations. Whole-body MRI is not recommended as a routine screening tool for the general population due to concerns about overdiagnosis, unnecessary testing, and cost-effectiveness.

However, whole-body MRI has its own limitations: the protocol for whole body MRI is not more effective than targeted protocol for specific part of body, for example, whole body MRI may not substitute cardiac MRI. For some body parts such as lungs, CT could be a better modality. For cancer screening, invasive methods such as colonoscopy and papsmear is unlikely be replaced.

I think this is a very promising technology that may have significant development in the future. It’s possible that eventually, everyone will undergo a whole-body MRI once a year as part of their annual checkup or even several times a year. It’s like what is depicted in science fiction movies – a full-body scan followed by numerous diagnostic results. Of course, for now, it is still quite expensive – costing a few thousand dollars per scan, unless for specific medial reasons it is not covered by health insurance, so not everyone has the financial capability to undergo the procedure whenever they want or as many times as they want.

Featured

Medical care for immigrant parents

When your parents come to the United States, what should you consider in terms of their healthcare?

If they’re here for a short-term visit, such as a six-month stay, short-term health insurance for visitors might be a good option. However, these plans usually don’t cover pre-existing conditions. If your parents have chronic conditions like diabetes, hypertension, or heart disease, they may need medications and potentially a visit to a clinic or emergency room.

US health insurance is largely employment-based, and due to parents’ immigrant status (B1/2 visitor visa), there are limited options for health insurance. A few possibilities are listed below, but local health insurance brokers may have more information.

Some employment-based health insurances allow you to add parents as dependents, like VA or Tricare
Some supplemental health insurance plans offer reduced costs by providing low out-of-pocket expenses
Some visitor health insurances offer options for acute onset of pre-existing conditions

What if an emergency occurs and your parents are uninsured or under-insured?

Emergency rooms: By law, all ERs in the US must accept patients regardless of their ability to pay. They will be seen in the ER, but you should expect to receive sizable bills. You can try to negotiate with the billing department later, but it’s never pleasant to receive a bill that could break the bank. If there’s a life-threatening emergency, don’t hesitate to take your parents to the ER.
Free clinics or fee-scaled community health centers: Different states and cities often have free clinics run by government or charity groups, usually open during regular 9-to-5 hours. If hospitalization is required, hospital social workers can help you apply for emergency Medicaid (depending on the state), which will cover in-patient stay costs.
Private cash-only clinics: You can find some private clinics in lower Manhattan/Chinatown or Flushing, NY that accept cash for visits.
Call your primary care physician and see if they can fit your parents into their schedule and charge a reasonable fee based on cash or a fee scale.
Some cash-based telemedicine services

What about medications?

Your parents can bring enough medication to the United States for the duration of their stay. Alternatively, they can:

Use low-cost medication programs at pharmacies like CVS, Target, or Walmart
Use GoodRx for wholesale medication prices
Ship medications from home through the mail, although Customs may scrutinize packages due to regulations preventing the import of cheaper medications to the US

If you have any experiences navigating the US healthcare system with immigrant parents, share them in the comments section!

n your parents come to the United States, what should you think about regarding their healthcare?

If they come here for a short-term visit, like a six-month stay, a short-term healthcare insurance for visitors could be your choice, but those usually don’t cover for existing conditions. If your parents have chronic conditions like diabetes, hypertension, heart diseases, etc, they may need medications and maybe some visit to the clinic or emergency room.

US healthcare insurance is largely based on employment and due to parents’ immigrant status (B1/2 visitor visa), there are very limited choices for healthcare insurance. A few options are as belows, but I suspect better knowledge is with local healthcare brokers.

-some employment-based healthcare insurances allow you to add parents as dependents, such as VA or Tricare

-some supplemental healthcare insurance offers some cost deduction by providing low out-of-pocket costs

-some visitor healthcare insurances offer choices for acute onset of pre-existing conditions

So what if an emergency happens and parents are not insured or under-insured?

-emergency rooms, according to law, all the ERs in the US have to accept patients no matter what, so they will be seen in the ER but you are going to expect to receive some bills with large numbers. Well, you can negotiate with their billing department later but it is always not pleasant to receive a bill that may make you broke. But if there is really any life emergencies, don’t hesitate to bring your parents to ER.

-free clinics or fee-scaled community health centers, usually different states and cities have some free clinics run by government or charity groups but they usually open on 9-to-5 regular hours. If they need hospitalization, the social workers at a hospital will help you apply for emergent Medicaid (depends on states), which will cover the costs of in-patient stay.

-private cash-only clinics, you can find some private clinics in lower Manhattan/Chinatown or Flushing, NY that accept cash for visits.

-call your own primary care physician and see if he/she can fit your parents into a schedule and charge a reasonable fee based on cash or fee-scale.

-some cash-based telemedicine services

How about medications?

They can bring enough medications to the United States for the duration of stay.

-some pharmacies provide low-cost common medications like CVS, Target, Walmart’s low-cost Rx program

-use GoodRx for wholesale prices for medications

-use online pharmacy (disclaimer: we are NOT related to those websites and can not guarantee their services or products) to obtain medications such as alldaychemist

-ship medications from home through mail but sometimes the Customs may be scrutinous about that since there are regulations to prevent smuggling cheaper medications to the US

If you have any experience exploring the US healthcare system with immigrant parents, share it in the comments section!

当你的父母来到美国时，你应该考虑他们的医疗保健问题。

如果他们只是短期访问，比如六个月，可以选择为游客提供的短期医疗保险，但这些通常不包括现有病症。如果你的父母患有慢性疾病，如糖尿病、高血压或心脏病等，他们可能需要药物，甚至可能需要去诊所或急诊室就诊。

美国的医疗保险主要基于就业，由于父母的移民身份（B1/2访客签证），医疗保险选择非常有限。以下是一些选择，但当地医疗保险经纪人可能有更好的了解。

一些基于就业的医疗保险允许您将父母作为受抚养人，如VA或Tricare
一些补充医疗保险通过提供较低的自付费用来降低成本
一些访客医疗保险针对急性发作的既往病症提供选择

那么，如果发生紧急情况，而父母没有保险或保险不足怎么办？

急诊室：根据法律，美国所有的急诊室都必须接受患者，无论他们是否有能力支付。他们会在急诊室得到救治，但你应该预料到会收到一些巨额账单。你可以稍后与账单部门协商，但收到可能让你破产的账单总是令人不悦。但如果真的有生命危险，千万不要犹豫，带你的父母去急诊室。
免费诊所或费用比例社区卫生中心：不同的州和城市通常有由政府或慈善团体运营的免费诊所，通常在正常的9点到5点开放。如果需要住院，医院的社会工作者会帮助你申请紧急医疗补助（取决于州），这将支付住院费用。
私人现金诊所：你可以在曼哈顿下城/唐人街或纽约法拉盛找到一些接受现金支付的私人诊所。
拨打你自己的初级保健医生电话，看看他/她是否可以诊治你的父母，并根据现金或费用比例收取合理的费用。那么药物呢？
他们可以带足够的药物到美国，供他们在停留期间使用。

或者
- 一些药店提供低成本的常见药物，如CVS、Target、沃尔玛的低成本处方药计划
- 使用GoodRx获取药品的批发价格
- 使用在线药店（免责声明：我们与这些网站无关，不能保证他们的服务或产品质量）获取药物，如alldaychemist
- 通过邮寄将药物从国内寄到美国，但有时海关可能会对此进行严格检查，因为有法规禁止将便宜药物走私到美国
如果您有与移民父母一起探索美国医疗系统的经验，请在评论区分享!