But the process isn’t something that most people know much about, which makes it hard for the average reader to understand, critique and analyze advancements in the startup space.

Drug development is a slow, capital-intensive process. It takes around 10 years and a billion dollars to get a single drug to market, while 90% fail in the process of trying to reach that goal.

It would be far less risky to invest in almost any other kind of technology. However, over $70 billion has poured into the space so far this year alone (per Crunchbase data).

This is all in the pursuit of creating drugs that, in some cases, .��

But it can be hard to understand or critique the technological advancements we’re seeing in drug development if you don’t know how the process works to begin with. So let’s talk about what’s driving billions of dollars in the most risky startup sector in the world.

Drug discovery

The drug discovery process often begins in a university lab, where scientists are nose-deep in petri dishes looking for new strategies to get a drug into the body and test some of the infinite molecular compounds to see which ones could create a breakthrough drug.

Most of this research is powered via the , a taxpayer-funded organization that contributes to .

After a discovery, the university may choose to spin out a startup helmed by the leading researchers who are thrust, often for the first time, into the world of private enterprise where they look to raise their first round of funding.��

Interest in drug discovery has increased since 2017, according to Crunchbase data. Around $1.6 billion has poured into the startup space so far this year, especially as the pharmaceutical industry tries to look for new targets—new parts of the cell for drugs to stick to.��

Artificial intelligence is driving a lot of that startup growth. Leveraging a class of data collection technology that emerged with genomics becoming widespread, AI has the ability to look for new targets and simulate clinical trials, potentially reducing risk in drug investment.

Preclinical trials

Once a startup identifies a handful of compounds that have the best chance of being effective, it moves into testing these compounds in labs and animals.��

During this time, startups are doing IND-enabling studies, which is a formal request to the Food and Drug Administration to start dosing humans. This might also be the time a startup applies for an Orphan Drug or Breakthrough Therapy designation which are given to therapeutics aiming to address a large unmet need in the medical market to fast-track the process.��

Preclinical trials are a necessary step to set dosing requirements and make sure drugs are safe before they enter humans. But they’re also extremely time-intensive for data that isn’t always accurate—petri dishes and animals aren’t the same as people.��

Enter the organ-on-a-chip, a budding class of startups that construct a downsized version of a human liver, mimicking the environment of that organ. One of the largest studies on organ-chips found that , a feat that could prevent death and permanent complications in human clinical trials.��

While still in its early stages, organ-chip startups like and could cut costs and give drugs a better chance of making it through clinical trials. Since 2009, startups in this space have raised around $75 million, according to Crunchbase

This is also around the time startups begin raising early series funding, which is almost exclusively predicated on companies having strong research.��

Clinical trials

Also called the Valley of Death, clinical trials are where most drugs meet their fate.

The time-consuming and expensive process got a much-needed makeover during the pandemic when COVID-19 shuttered clinical trial sites. Participating requires people to travel to clinical trial sites, often during work hours, for years at a time. Patients will drop out part way through studies . If we don’t know how a drug may affect people with different lifestyles, dietary habits and sleep schedules, we can’t truly understand its safety.��

For the first time, pharma companies could conduct clinical trials remotely using a slew of new technology that exploded onto the scene in 2021. Between 2020 and 2021, funding in the space went from $968 million to over $2 billion, according to Crunchbase data, as it became clear remote clinical trials were here to stay. They were by and large more effective, but it will take years before we understand the full scope of the impact.��

Other startups, like , help to find the right patients to join clinical trials. If your drug is meant to treat a specific kind of cancer at a specific stage of the cancer and requires qualifications, it’s difficult to comb through tens of thousands of patients to make sure they’re the right fit for a human study.

FDA review

The FDA approves most drugs based on three criteria: if it’s safe, if it’s effective and if it’s better than something that already exists. Sometimes the FDA will ask for additional studies to be conducted, and will continue monitoring the drug when it’s on the market.��

Many of us take tiny little pills every day without knowing the intense risk that comes with taking them. Advancements in drug development may not sound as cool as consumer-focused technology, but they’re necessary to create drugs that are actually safe, and to do so as quickly as possible.��

Over time, we’ve found the answers to diseases that were previously considered incurable. What’s next?

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The company’s long-time partner, , is developing the test, which will be available as soon as Friday afternoon.

“Drive-through testing is an option, but it doesn’t exist everywhere,” Dr. Chris Hall, Nurx’s senior medical adviser said in an interview with Crunchbase News. “We feel that all of the testing options are necessary to address this crisis, but we just feel like home-based testing is going to be a really important part of that.”

Nurx, which is based in San Francisco, has more than $93 million in funding and is backed by investors including and . It last raised $32 million for its Series C round in August 2019.

Nurx first published a blog post to answer a few questions about coronavirus, before the company realized it could play a bigger role in the solution. The startup has been working for about two weeks on making an at-home test available, Hall said, and has been meeting with Molecular Testing Labs multiple times every day, including weekends. The entire Nurx team has been working on rolling out the at-home COVID-19 test.

“We began to realize pretty quickly after creating that blog post that we were perfectly situated to pivot to this service,” he said.

While Nurx is perhaps best known for delivering birth control and the HIV-prevention medication PrEP, it has been in the at-home testing space for a while, providing testing kits for sexually transmitted infections, HIV, Hepatitis C and HPV.

Getting tested for coronavirus in the United States , and Nurx is one of several startups working on making more COVID-19 tests available since the gave certified labs the green light to develop and distribute them. Austin-based at-home testing startup also announced plans to have an at-home COVID-19 test available next week. Los Angeles’ and San Francisco’s also announced home test kits.

A person wanting to get tested for the virus can use the Nurx app or website, indicate interest in the test and fill out a survey with questions about symptoms. A Nurx provider will then review the information and decide if the patient should be tested. If so, the company will send a test kit with expedited shipping and instructions on how to complete the test and how to send the kit back to Molecular Testing Labs’ facility in Vancouver, Washington.

To complete the test, patients will perform a throat swab. Molecular Testing Labs performs a polymerase chase reaction (PCR) test to determine if the patient has COVID-19.

A patient should receive results within 24 to 48 hours, Hall said, and Nurx will advise them what next steps they should take, such as isolation. Patients will receive automatic advice, but if they have unanswered questions they can communicate with a provider.

Nurx will have the test, which will cost under $200, available on a “limited basis” when it’s first introduced. The company’s planning to provide 10,000 home testing kits in the upcoming weeks and, according to a company spokeswoman, 100,000 tests in the near future.

“We are here to work with everyone just to increase the sheer number of tests that are out there,” Hall said. “No single provider and no single company or initiative is going  to be able to solve this problem alone.”

Editor’s note: This article was updated post-publication to reflect that patients will now perform a throat swab rather than a nasal swab to complete the test.

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The 2-year-old Cambridge, Massachusetts startup is based out of at the (MIT) and had been working on developing technology for rapid diagnosis of diseases such as dengue and zika. Now, of course, E25Bio is turning its attention to creating early and accessible tests to diagnose the novel and rapidly-spreading coronavirus, which has caused a global pandemic.

Its goal is to be able to distribute more rapid, accurate and affordable detectors for coronavirus that can be distributed at scale across geographies. The startup plans to begin testing on human samples next week. The tests should be available for sale – at a cost of less than $30 – by late April depending on the regulatory timeline, according to a company spokesperson.

“We ultimately want to be able to have our tests at hospitals, clinics, and pharmacies (for at-home tests), however we are still exploring the details of potential distribution partnerships,” the spokesperson told me via email.

E25Bio’s rapid diagnostic tests use nanoparticle technology to capture virus or viral proteins secreted into the human body. They are based on technology developed by Dr. and Dr. Lee Gehrke, the Hermann von Helmholtz Professor of Health Sciences and Technology at MIT.

“The same way a hormone is detected on a pregnancy test, our diagnostics provides doctors and patients with results in 15 minutes or less,” said Bosch, who serves as CTO of E25Bio.

Fast tracking

In the wake of the chaos, the recently announced it would fast track diagnostics for the virus through its (EUA), opening the door for both public and private institutions to attack the problem.

, co-founder and CEO of E25Bio, said the global public health system will require “a concentrated, unified strategy to better respond to the current pandemic.”

Khosla Ventures founder said that “in this time of crisis we need every effort to get testing at scale on the market.”

“We are excited about what E25Bio is capable of shipping in a short amount of time: a test that is significantly cheaper, more affordable, and available at-home for consumers without having to rely on primary medical services and can lessen the load on our healthcare systems,” he said in a written statement.

The new funding will go toward research and development, clinical studies and scaling the company’s launch for diagnostic tests upon receiving EUA approval. E25Bio had raised  a $2.3 million last August, according to Crunchbase.