BLACK FRIDAY, CYBER MONDAY, THANKSGIVING, DIWALI, HANUKKAH, CHRISTMAS, NEW YEAR SALE - 30% OFF ENTIRE ORDER !!!

Everything You Need to Know About Coronavirus Testing

Who’s sick? How bad? How fast will the disease spread? Nobody has good answers, for one simple but terrifying reason: There aren’t enough tests.

Unlike for the flu, or previous coronaviruses like SARS or MERS, or STD, or a host of other infections, health workers have no way to find out whether a person sitting in front of them has Covid-19 or not.

That technology actually exists and is relatively simple. They just don’t have access to it. Right now, four months into a global pandemic, doctors and health workers have no way of testing everyone to see whether they have Covid-19.

That may at last be about to change. On March 13, the FDA granted approval for commercial tests from two companies, Swiss pharmaceutical giant Roche and medical device-maker Thermo Fisher. Their expertise in fast, bulk-scale medical test construction and distribution means their promise to roll out 2 million tests almost immediately is actually plausible.

The American Enterprise Institute’s program to estimate total US testing capacity currently puts that number at just over 22,000 tests a day-roughly twice the daily capacity of South Korea, a country with just one-sixth the population of the US and about one-hundredth the square mileage. That shortfall limits what scientists know about the disease-and therefore what they know about how to fight it.

World is behind a fearsome curve, looking at a potential explosion of infection numbers. A large percentage of will get sick enough to require hospitalization, and some of them are going to die.

But nobody had enough tests in January or February to try to get ahead of that problem, and nobody has enough tests now to know how big a wave is yet to come. The reasons why are both scientific and political, and it’ll take deft science and politics to fix them.

Broadly, the response to an infectious disease outbreak has two phases: containment and mitigation. The containment phase happens early, when initial cases begin to appear. Public health workers tasked with surveillance do interviews to determine all the people an infected person might have come into contact with, to notify them and either isolate or treat them, in an effort to reduce further spread. But you can see where this is headed: Without the ability to test whether people are infected, health workers can’t effectively wall off these networks.

In the second phase, when the disease has spread beyond any public health system’s ability to investigate and handle individual cases, people need to understand what they’re up against. Without the ability to test vast numbers of people, it’s hard to calculate how many of the sick will need hospitalization, or will likely die. These numbers will be (figuratively and literally) all over the map. With Covid-19, the estimated percentage of infected people who die of the disease, or the “case fatality rate,” has varied from less than 1 percent to 15 percent, depending on the depth of testing conducted by each nation and how much data they actually released. Lots of factors might explain this variance, from a population’s overall wellness to its demographics to the nation’s health care system. It’d be nice to know which percentage is correct.

As the fight moves from individuals to entire populations, the goal of mitigation measures like social distancing, canceling large events, closing schools, and telling people to work from home is, sure, to lower the number of infections, but also to “flatten the curve,” as epidemiologists say. That curve is the number of sick people at a given time, and the best thing that could happen right now would be squishing that tsunami into a ripple, not necessarily reducing the overall number of infections but spacing them out, slowing them down. That’s because US hospitals have limited staff, equipment, and space, with just 2.9 hospital beds per 1,000 people. That’s fewer than Italy but more than Iran, whose health systems both got utterly slammed. And that’s also in the hope that, with more time to work the problem, new treatments might get figured out.

When testing for a new virus like SARS-Cov-2, the first wave of diagnostics almost always relies on two important (though not particularly modern) technologies.

The first, PCR, or polymerase chain reaction, is a DNA amplification technique that is routinely used in the lab to turn tiny amounts of DNA into large enough quantities that they can be analyzed. Invented in the 1980s by Kary Mullis, the Nobel Prize-winning technique uses cycles of heating and cooling to make millions of copies of a very small amount of DNA. When combined with a fluorescent dye that glows in the presence of DNA, PCR can actually tell scientists how much DNA there is. That’s useful for detecting when a pathogen is present, either circulating in a host’s body or left behind on surfaces.

But if scientists want to detect a virus like SARS-CoV-2, they first have to turn its genome, which is made of single-stranded RNA, into DNA. They do that with a handy enzyme called reverse-transcriptase. Combine the two techniques and you’ve got RT-PCR.

Currently, RT-PCR is the only way to determine if a person has Covid-19. No other kinds of tests can yet distinguish the virus that causes it from influenza or the other dozen or so respiratory bugs that are circulating this time of year. It’s a very standard, reliable technique used in microbiology labs almost everywhere that can be quickly applied to clinical testing.It’s the fastest possible kind of test to develop.

But until other kinds of tests can be developed and approved, all Covid-19 tests have to be conducted in a lab by trained technicians. They require PCR machines and people trained to use them, so they can’t be performed in a clinic or inside a patient’s home. Since PCR is such a workhorse of the biology world, lots of research labs at universities and hospitals have the necessary equipment and personnel. But in the world, only labs that have been certified by proper agencies can process clinical samples. That approval process can take months. World has one of the more cumbersome-or, you could say, diligent-regulatory systems for testing. We’re very concerned about false positives, just as damning as false negatives.

The test itself only takes about a day to run if you have all the required reagents. But shortages and shipping logistics can easily add days or even weeks to get a result. This is, in fact, already happening, but more on that later. Let’s start with what should happen:

  1. The very first step is collecting a sample. Using a sterile soft plastic stick, health care workers swab the inside of a patient’s nose or back of the throat. The goal is to collect material that’s recently been in the lungs, where the virus is believed to replicate. That stick then gets sealed up and shipped in a cold container to the testing lab. The sample has to stay between 35 and 40 degrees Fahrenheit, and if it’s not processed within four days it either goes into a freezer or gets thrown out.
  2. Once in a lab, the first step is to separate out the RNA from everything else in the sample-human cells, proteins, enzymes that would chew up that viral genetic code. This is called RNA extraction. If you’re doing it by hand, this process usually involves adding chemicals and centrifuging the sample so the RNA winds up in a different layer from everything else. Several large biochemical suppliers make kits with everything you’d need to RNA extraction. There are also automated machines that do it, too.
  3. Once the RNA has been purified, the next step is to add the reverse transcriptase enzyme that converts it to DNA-going from one strand to two. Then the DNA goes into a test tube along with batches of loose nucleotides, a DNA-building enzyme, and short synthesized DNA fragments called “primers.” These primers have been designed to find and bind to specific segments of the viral genome. In other words, they should, if they work right, recognize and amplify only genetic material from the virus, and not from anything else that might be in the sample, like human or bacterial DNA.
  4. This all happens inside a PCR machine, an instrument that runs coordinated temperature cycles. As it heats the tube, the DNA’s double helix separates into two strands, exposing each side. When it subsequently lowers the temperature, the primers lock onto their targeted segments of the exposed DNA. The enzyme uses these primers as a starting place and begins building complementary strands of DNA according to the exposed sequence. About five minutes later, where once there was one strand of DNA, now there are two. After 30 to 40 cycles of this process, a single copy of DNA multiplies to hundreds of millions. That’s enough DNA that scientists can begin to detect it.
  5. They do that with a fluorescent dye that is added to the test tube during the PCR amplification phase. It only glows in the presence of DNA. As the number of copies of DNA increases, so does the amount of light emitted. A special light-measuring instrument inside the PCR machine then reads out these fluorescence patterns to determine which samples have the virus in them and which don’t. If there’s coronavirus in your sample, then its RNA will be transcribed into DNA and amplified along with a fluorescent signal that tells you if the test is positive or negative.
  6. What’s important to remember about RT-PCR is it’s not one test for one virus. It’s a method for identifying specific genetic sequences used in academic, commercial, and public health labs around the world. And the exact recipe scientists follow to get trusted results-which RNA extraction kit, which PCR machine, which primers-can vary. These recipes are referred to as “protocols.”
  7. When a novel disease like Covid-19 emerges, universities, national research institutes, and public health organizations are usually the first to produce RT-PCR protocols. They have the biosafety labs to handle deadly new pathogens, including the ability to grow them-a crucial step for validating any tests. Once those agencies have a working test, they can deploy it to local public health labs and hospitals. Eventually, if the outbreak sticks around, commercial labs and diagnostic companies will produce their own tests, which may or may not require the same amount of expertise and manual lab work.
  8. Starting in January, shortly after Chinese researchers released the first whole genome sequence of SARS-CoV-2, groups around the world began designing, testing, and publicly posting protocols for detecting the new coronavirus with RT-PCR. As a resource for testing labs, the World Health Organization has been keeping a list of these protocols, as well as guidelines for best practices.
  9. Among them is a protocol developed by the US Centers for Disease Prevention and Control. Its test consists of four sets of primers. The first two, called N1 and N2, target unique regions of the SARS-CoV-2 genome that code for a protein that encapsulates and protects the virus’s genetic material. The third primer targets a gene common to the whole family of SARS-like viruses. The fourth and final primer targets a human gene, which serves as a positive quality control. Basically, it’s a target that the test should pick up 100 percent of the time. If it doesn’t, it’s a sign the test isn’t working the way it should. The kits also include instructions for testing a negative control-DNA that isn’t related to SARS-CoV-2-which should not react with the first three primers. The CDC began using this test in January on a limited number of samples from people with a history of travel to Wuhan, then the epicenter of the Covid-19 outbreak.
  10. On February 4-two weeks after the CDC had detected the first Covid-19 case in the US-the US Food and Drug Administration issued emergency authorization of the CDC’s test, skirting normal regulatory channels to make it available to certified public health labs around the country. The CDC packaged these primers, along with their associated fluorescent probes, into kits that could each be used to process between 700 and 800 samples. Starting on February 5, the CDC finally began sending out 200 of those kits to the 115 domestic public health labs qualified to run the test through its distribution arm, the International Reagent Resource.

That’s where things started to go sideways.

Blunders, Confusion, and Red Tape

  1. As soon as the test kits arrived in the state laboratories, scientists there set about the first order of business-verifying the tests’ results. That involved running known samples through the test to make sure it picked up SARS-Cov-2 when it should, and didn’t erroneously flag harmless, virus-free samples. But a number of those labs ran into issues. On some, the negative control failed. On others, what should have been positive results came back as inconclusive.
  2. On February 12, the CDC announced that the problem was the result of a faulty reagent. The third primer, the one that picks up the whole family of coronaviruses, wasn’t working properly. CDC officials told labs to sit tight, new kits were coming. As a result, for weeks, only a handful of laboratories in just a few states had the ability to test for Covid-19. Everywhere else, health departments with suspected cases on their hands had to send samples directly to the CDC for testing. And under the CDC’s narrow testing guidelines at the time, only people with symptoms and a history of travel to China were eligible to receive a test. This meant many infectious people were missed during the crucial early days of the virus’s spread to the US.
  3. As the CDC struggled to get out more tests, other countries experiencing their own outbreaks moved to adopt other protocols publicized by the WHO. And in the US, by February 25, only 12 US labs outside the CDC, in just five states, had the ability to test for the virus. At the time, only 426 people in the US had been tested, according to archived versions of the CDC website. As of March 2, the agency stopped reporting the number of people tested. Meanwhile, South Korea was reportedly testing 15,000 people per day-almost as many as the United States has tested to date in total.
  4. In principle, any certified lab in the US with the right equipment could have followed suit-including hospitals and commercial labs. All they’d need to do is use any one of the protocols publicized by the WHO as a guide for ordering primers from any number of DNA synthesis companies and push forward with testing. But in reality, they were paralyzed, stuck behind a wall of freshly stretched red tape, able only to wait on the CDC to ship more kits.
  5. See, when federal health authorities declared Covid-19 a public health emergency back in January, it triggered a set of rules requiring any tests to pass the FDA’s “emergency use approval” process. These rules raise the bar for tests developed and run inside a single laboratory. In a non-emergency situation, the FDA generally stays away from regulating these kinds of tests. But under the emergency rules, any lab that wanted to test for Covid-19 had to perform a number of validation studies and submit data to the FDA for review. These require viral specimens, which can be hard to obtain if you’re not the CDC.
  6. For consistency’s sake, the FDA opted to limit its initial emergency approval to just the CDC test, to ensure accurate surveillance across state, county, and city health departments. The testing strategy the government picked was very limited. Even if the tests had worked, they wouldn’t have had that much capacity for a while. They basically were saying, we’re going to use a test not only developed by CDC, but CDC has to wrap it up and send it to the lab, and it’s just going to be state labs doing it.
  7. The effect was that the nation’s labs could only run tests using the CDC’s kits. They couldn’t order their own primers and probes, even if they were identical to the ones inside the CDC kits. And when the CDC’s kits turned out to be flawed, there was no plan B.
  8. But no one outside the government yet knows why, at that moment, the US didn’t switch to a test developed for the WHO, in use in more than 120 countries.
  9. On February 29, facing mounting pressure to expand testing capacity in the face of a growing public health catastrophe, the FDA changed its regulations to allow certified clinical labs to develop and begin using their own tests to detect Covid-19 without prior approval. As soon as they found community transmission cases on the West Coast, that was a wake-up call. By the end of the week, the FDA just said, ‘Get started.’”
  10. Under the new policy, the FDA review will still be required, but labs will have two weeks to send data to the FDA after internally validating the tests. In the meantime, they can start using their diagnostics to test patient samples.
  11. With the relaxed protocols, two of the largest diagnostic commercial labs, Quest Diagnostics and LabCorp, have begun conducting a few thousands tests a day, according to data compiled by the American Enterprise Institute. Quest says the company expects to have the capacity to conduct “tens of thousands of tests per week” by the end of March. Universities and hospitals have also booted up.
  12. But where regulatory barriers have been removed, logistical ones have arisen. As more labs come online, nearly every step in the RT-PCR test has the potential to run into bottlenecks. The biggest one, right now, is RNA extraction kits. Everyone is trying to order these ancillary ingredients, and we’re hearing from member labs that many of them are impossible to get right now.
  13. The CDC’s protocol recommends an RNA extraction kit sold by the company Qiagen. Those kits are now on backorder, due to the “extraordinary pace” at which the world has increased coronavirus testing over the last few weeks. There are also reports of automated RNA extraction machines and RT-PCR instruments being on back order. Not all labs have versions of these machines that have been cleared by the CDC as qualified for Covid-19 testing. The ones that don’t are now scrambling to source them.
  14. Qiagen is hiring new staff and ramping up its manufacturing sites in Europe, increasing to three shifts a day. And the FDA has recently moved to allow test-makers to substitute kits from another European manufacturer, Roche. But the current shortages are expected to further hamper the US’ ability to test potential Covid-19 patients in a timely manner. There’s not going to be a fast solution to this. It could take several weeks to resolve this supply chain issue, meaning that the demand for testing is going to outstrip supply for the foreseeable future.
  15. More testing kits would certainly ramp up capacity. Eventually, new testing technologies might also help.At least 20 companies have announced plans to develop “molecular point-of-care” tests, basically all-in-one, mostly automated systems that a frontline health care worker can use to get results in a half hour, instead of in days. You take the sample from the patient, usually a nose swab or sputum, and then put it into a cartridge, put that into the machine, and hit a button. You get a diagnosis in 30 minutes, is what they’re aiming at. They can also run a high volume.”
  16. Cepheid, one of the major companies that makes these kinds of kits for other diseases, has a Covid-19 version in the pipeline, and Coyote Bioscience already has one deployed in China. There’s even one in development that tests for both Covid-19 and influenza at the same time, good for excluding people from isolation wards and getting them appropriate care.
  17. Crispr-based diagnostics for detecting the coronavirus are also in the works at startups like Sherlock Biosciences and Mammoth Biosciences. These tests use Crispr’s programmable gene-seeking capabilities to deliver a diagnosis in under an hour without the need for fussy lab instruments. Mammoth published a preprint on March 10, describing a test the company developed for SARS-CoV-2 that works with paper test strips like those you’d find in a drugstore pregnancy test. The company is currently in the process of further validating its initial results.
  18. Another in-demand approach would look for antibodies to the virus in the blood of patients, a so-called serological test. That’d be useful, because in addition to identifying people with Covid-19, it could tell you if someone was once infected but then recovered. The better your surveillance, the more cases you’re going to catch, but even with perfect surveillance you won’t catch everything. Until we’ve got a full test of this type of assay, we don’t know how many cases we’ve missed.
  19. A serological test would also probably be cheaper than a PCR-based one, and more suited to automation and high-throughput testing. A researcher in Singapore is testing one now.
  20. Serological tests may be less accurate than molecular ones-but on the plus side, SARS-CoV-2 also shows up on the serological tests designed for the original SARS virus. Whether that’ll help with developing new tests is unclear. The samples of original SARS were thrown away. People worried that the risk was higher having those samples than not having them. All of the funding we had during the SARS period to develop the serology, to develop the vaccine, all disappeared as soon as the virus disappeared.

What Does This Mean for You?

This patchwork rollout of testing capacity means that whether or not you can get a diagnosis for Covid-19 if you feel sick depends largely on where you live. According to a recent report some hospitals can’t provide testing, because they don’t have enough of the right kinds of masks to protect health care workers while they collect patient samples. Others are having to ration tests, limiting them to only the most severe cases, and encouraging people with mild symptoms to stay home. At this point, every state, county, and some cities have their own policies about who’s eligible to receive a test. The system is not really geared to what we need right now.

At a White House press conference US Government attempted to address that failing. They declared Covid-19 a national emergency, clearing the way for an infusion of funds and decreased regulation at the state and local level. They also announced the creation of a public-private partnership with several national big-box stores and pharmacies, including Walmart and CVS, to allow parts of their parking lots to be set aside for drive-through testing. Partnerships with testing companies like Roche, Quest, and LabCorp meant that they’ll have the ability to do in the millions over a very, very quick period of time, and they expect to eventually spin up to between 15,000 and 20,000 tests a day.

There’ll be a new system for getting tested too. There is also a new website to be created by Google, that would allow people to enter their symptoms and, if they met certain criteria, get the location of a parking-lot drive-through test facility where they would be swabbed for SARS-CoV-2. The implication seemed to be that people still need to have symptoms to get tested, which doesn’t address some of the broader epidemiological questions. Verily is also working on such technology.

What should you do in the meantime?

  1. Practice your own social distancing, avoiding large gatherings.
  2. If you can work from home, it’s time to do that.
  3. If you learn you’ve had contact with someone who has Covid-19, self-isolate for 14 days.
  4. If you start to feel sick, do the same.
  5. Don’t go to the hospital if it’s the kind of mild illness that would normally just keep you home.
  6. Hospitals are for people with chest pain, or who are having trouble breathing.
  7. Wash your hands a lot, with soapy water, for at least 20 seconds.
  8. Maybe clean your phone and other gadgets.
  9. Stop touching your face, even though it’s hard.
  10. Check in on your neighbors, especially if they’re elderly or sick. They might need supplies.

And remember that this pandemic hurts everyone in different ways-the economic hit to store owners, the lost school time for kids, the potential for illness or worse. But it hurts the most vulnerable people the most. People who don’t have health insurance, who don’t have the kind of jobs that include sick leave, who don’t have ready access to child care, or who already have weakened immune systems from other issues are bearing the biggest load here. Until governments catch up to helping them out, anything you can do for them is going to be part of the real fight against the disease, the one we’re already in.

At-home tests for coronavirus are here. Should you take them?

With delays in testing hampering the country’s ability to accurately track the new coronavirus and shelter-in-place orders keeping many people at home, startups are swooping in with a seemingly ideal solution: at-home tests.

Over the next week, at least four startups are launching the first at-home tests for Covid-19. The companies, whose tests have been mostly greenlit — but not approved in the conventional sense — by the U.S. Food and Drug Administration under new guidelines instituted for the coronavirus crisis, aim for their diagnostics to offer some certainty to people who have up until now been unable to get tested as a result of the shortage of test kits. Most of the companies have put their other efforts on hold to focus on coronavirus.

“We are pivoting from our prior service lines to make this available,” Chris Hall, senior clinical advisor to San Francisco-based telehealth startup Nurx, told STAT. “It’s a heavy lift, but we think it’s important.”

Experts caution that the at-home tests are a piecemeal solution to the country’s failure to test early and widely for Covid-19. The US currently lags far behind every other country with a high proportion of coronavirus cases.

It’s better than nothing, for sure. But we’re two months late. It’s a small attempt to help a little bit. It’s not worthless, but it’s so little, so late, it’s embarrassing.

There are also concerns that the tests, which customers will be able to order online for between $150 to $200, may not meet the FDA’s high standards for traditional approval. Coronavirus testing is a delicate task. It’s crucial not only to test people at the right time, but also to get the sample from the right place in the nose or throat. There are also worries that supply chain shortages could stymie efforts to distribute the tests at scale.

Usually, the FDA requires evidence showing how people may respond to test results before it allows them to be sent to people. The agency also typically takes a good hard look at the information sent to the consumer which is suspected not done here for lack of time.

Startup executives and medical directors, however, said their tests have gone through all of the required steps to make them ready for consumers. They hope the tests can help alleviate the anxieties of the worried well and keep them out of health care facilities already crippled with coronavirus-related demand.

It’s a nice way to tell people: Stay away from your local health clinic until it’s safe to come out says Caesar Djavaherian, the co-founder and medical director of primary care startup Carbon Health,

Why startups jumped into at-home testing

Several startup executives — many of whom are also clinicians — said their desire to create an at-home test was influenced by early challenges diagnosing their own patients whom they suspected of having Covid-19. In the early days of the U.S. outbreak, for example, doctors at one of Djavaherian’s Carbon Health clinics in Mountain View, Calif., saw a patient with coronavirus symptoms who’d recently returned from travel to Wuhan, China, where the pandemic began. The patient had wanted to be tested for Covid-19, but Carbon had to turn her away because at the time, she didn’t meet the stringent CDC test criteria.

They don’t know what happened to her and they hope she got tested and ended up being negative.

Since then, Carbon Health has diagnosed a total of 10 positive cases of the virus using its traditional in-clinic tests. For the past few weeks, the company has been sharply focused on creating an at-home test.

The world remains behind on testing.

For all their weaknesses, at-home tests may still help some people, such as younger patients with milder symptoms, who might either visit a hospital or continue to spread the virus without knowing they have it. Of particular concern tare younger people who live with or care for older people, who are particularly vulnerable to dying from the virus.

You might not be sick enough to go to the ER, you might not have severe shortness of breath, but you have cold and flu symptoms and you live with your mom who’s 75 and has heart problems. And you know that if you have it, there’s a chance you could kill her. You might be in your 20s. You won’t die from this. It’s the impact on your family — that’s what we’re trying to lessen.

Carbon’s test will cost $167.50.

Concerns with at-home tests

There remain some important concerns about how well the tests will work, according to Topol and Greely.

Timing, for example, is key: Someone who takes a test too early may later come down with Covid-19 but wrongly believe they are free from the virus, something also known as a false-negative. That person might be more likely to go out and socialize, unknowingly infecting others.

LetsGetChecked’s test, which can ship to patients in two to three days, will take as long as a week to deliver results to patients. The tests being offered by Nurx and Carbon are faster. Both aim to use express shipping services, such as those provided by a courier service or FedEx, to get test kits to customers the day they’re ordered. Both companies said they’d deliver results within three days.

Topol believes that’s too much time to waste.

The 24–48 hours window is, unacceptable. In that time, the person doesn’t know whether they should be hunkering down or doing something else. Or let’s say you’ve had contact with a known person. You’re sleepless, you’re high-anxiety, how long do you have to live with that?

Taking an at-home test presents other problems as well. For an accurate test, a patient must swab deep in the back of the nose or throat where the virus is most active. Similar to a test that’s taken too early, a swab that’s done too shallowly could wrongly convince someone that they don’t have Covid-19.

It’s not a very comfortable thing, if you do it right. It can feel like you’re trying to gag yourself. So the chance of false-negatives is high.

Nurx’s said that’s an issue it planned for, however. After first considering a nasal swab, the company switched to an oral one that they say is easier to use. Nurx’s test does not have approval under the FDA’s emergency rules, but instead meets the agency’s latest standards for Covid-19 tests, which simply require compliance with the government’s basic requirements for federal clinical labs, also known as CLIA. It will cost less than $200.

There is one final hiccup to the at-home test process, according to Greely: People getting a test result at home may react in unexpected ways compared with how they might handle the news were a clinician delivering it in-person.

If consumers using [these] tests get positive results, what will they do? “Rush to an ER? Rush to a doctor’s office? Sink into depression? If they test negative, will they stop all precautions, forgetting that the result is a snapshot in time and that they can still get infected? If the test results suggest things for them to do, will they take the advice?”

At present, the startups have a patchwork of ways to deliver the results. Some, like Everlywell, whose test is also not technically FDA-approved and costs $135, require a clinician’s sign-off to ship the test. Others, such as Nurx, pair their results with educational materials about quarantine procedures and social distancing.

Shortages of testing materials

Basic manufacturing and shipping concerns could also hamper efforts to make at-home tests widely available. Shortages of basic ingredients like swabs and reagents, key for jumpstarting the chemical reactions necessary for the tests to work, are already affecting some startups, including Nurx. Even large pharmaceutical companies including Roche and Thermo Fisher, which recently had their in-clinic tests approved by the FDA, have been forced to reckon with supply chain issues that have limited their distribution.

The concerns about the supply chain are real concerns. It’s really about what the supply chain will be able to manage, and we don’t know what that number is, quite frankly.

LetsGetChecked and some other startups are ordering the test components from a supplier and self-assembling the kits. Others, like Everlywell, Carbon, and Nurx, are working with a partner company that handles both the components and the assembly.

There are significant supply chain issues that relate to swab availability, and they’re dealing right now with an inability to assemble as many kits as they would like.

Regardless of the challenges, the startup executives remain optimistic. While Nurx aims to have 10,000 tests available, Everlywell plans to launch 30,000 tests per day. Same with Carbon and LetsGetChecked about how many tests they aimed to ship.

We think there’s a chance we’ll have some days where our supply is limited, but we’re hopeful that we’ll at least be able to test some people every day say the startups.


Leave a comment

Liquid error: Could not find asset snippets/jsonld-for-seo.liquid Subscribe