Bit Bio’s “enter button for the keyboard to the software of life” nabs the company $41.5 million

Bit Bio, the new startup which pitches itself as the “enter button for the keyboard to the software of life” only needed three weeks to raise its latest $41.5 million round of funding.

Originally known as Elpis Biotechnology and named for the Greek goddess of hope, the Cambridge, England-based company was founded by Mark Kotter in 2016 to commercialize technology that can reduce the cost and increase the production capacity for human cell lines. These cells can be used in targeted gene therapies and as a method to accelerate drug discovery at pharmaceutical companies.

The company’s goal is to be able to reproduce every human cell type.

“We’re just at a very crucial time in biology and medicine and the bottleneck that has become really clear is a scalable source of robust human cells,” said Kotter. “For drug discovery this is important. When you look at failure rates in clinical trials they’re at an all time high… that’s in direct contradiction to the massive advancements in biotechnology in research and the field.”

In the seventeen years since scientists completely mapped the human genome, and eight years since scientists began using the gene editing technology known as CRISPR to edit genetic material, there’s been an explosion of treatments based on individual patient’s genetic material and new drugs developed to more precisely target the mechanisms that pathogens use to spread through organisms.

These treatments and the small molecule drugs being created to stop the spread of pathogens or reduce the effects of disease require significant testing before coming to market — and Bit Bio’s founder thinks his company can both reduce the time to market and offer new treatments for patients.

It’s a thesis that had investors like the famous serial biotech entrepreneur, Richard Klausner, who served as the former director of the National Cancer Institute and founder of revolutionary biotech companies like Lyell Immunopharma, Juno, and Grail, leaping at the chance to invest in Bit Bio’s business, according to Kotter.

Joining Klausner are the famous biotech investment firms Foresite Capital, Blueyard Capital and Arch Venture Partners.

“Bit Bio is based on beautiful science. The company’s technology has the potential to bring the long-awaited precision and reliability of engineering to the application of stem cells,” said Klausner in a statement. “Bit Bio’s approach represents a paradigm shift in biology that will enable a new generation of cell therapies, improving the lives of millions.”

Photo: Andrew Brookes/Getty Images

Kotter’s own path to develop the technology which lies at the heart of Bit Bio’s business began a decade ago in a laboratory in Cambridge University. It was there that he began research building on the revolutionary discoveries of Shinya Yamanaka, which enabled scientists to transform human adult cells into embryonic stem cells.

“What we did is what Yamanaka did. We turned everything upside down. We want to know how each cell is defined… and once we know that we can flip the switch,” said Kotter. “We find out which transcription factors code for a single cell and we turn it on.”

Kotter said the technology is like uploading a new program into the embryonic stem cell.

Although the company is still in its early days, it has managed to attract a few key customers and launch a sister company based on the technology. That company, Meatable, is using the same process to make lab-grown pork.

Meatable is the earliest claimant to a commercially viable, patented process for manufacturing meat cells without the need to kill an animal as a prerequisite for cell differentiation and growth.

Other companies have relied on fetal bovine serum or Chinese hamster ovaries to stimulate cell division and production, but Meatable says it has developed a process where it can sample tissue from an animal, revert that tissue to a pluripotent stem cell, then culture that cell sample into muscle and fat to produce the pork products that palates around the world crave.

“We know which DNA sequence is responsible for moving an early-stage cell to a muscle cell,” says Meatable chief executive Krijn De Nood.

If that sounds similar to Bit Bio, that’s because it’s the same tech — just used to make animal instead of human cells.

Image: PASIEKA/SCIENCE PHOTO LIBRARY/Getty Images

If Meatable is one way to commercialize the cell differentiation technology, Bit Bio’s partnership with the drug development company Charles River Laboratories is another.

“We actually do have a revenue generating business side using human cells for research and drug discovery. We have a partnership with Charles River Laboratories the large preclinical contract research organization,” Kotter said. “That partnership is where we have given early access to our technology to Charles River… They have their own usual business clients who want them to help with their drug discovery. The big bottleneck at the moment is access to human cells.”

Drug trials fail because the treatments developed either are toxic or don’t work in humans. The difference is that most experiments to prove how effective the treatments are rely on animal testing before making the leap to human trials, Kotter said.

The company is also preparing to develop its own cell therapies, according to Kotter. There, the biggest selling point is the increased precision that  Bit Bio can bring to precision medicine, said Kotter. “If you look at these cell therapies at the moment you get mixed bags of cells. There are some that work and some that have dangerous side effects. We think we can be precise [and] safety is the biggest thing at this point.”

The company claims that it can produce cell lines in less than a week with 100 percent purity, versus the mixed bags from other companies cell cultures.

“Our moonshot goal is to develop a platform capable of producing every human cell type. This is possible once we understand the genes governing human cell behaviour, which ultimately form the ‘operating system of life’,” Kotter said in a statement. “This will unlock a new generation of cell and tissue therapies for tackling cancer, neurodegenerative disorders and autoimmune diseases and accelerate the development of effective drugs for a range of conditions. The support of leading deep tech and biotech investors will catalyse this unique convergence of biology and engineering.”

 

Immunai wants to map the entire immune system and raised $20 million in seed funding to do it

For the past two years the founding team of Immunai had been working stealthily to develop a new technology to map the immune system of any patient.

Founded by Noam Solomon, a Harvard and MIT-educated postdoctoral researcher, and former Palantir engineer, Luis Voloch, Immunai was born from the two men’s interest in computational biology and systems engineering. When the two were introduced to Ansuman Satpathy, a professor of cancer immunology at Stanford University, and Danny Wells, who works as a data scientist at the Parker Institute for Cancer Immunotherapy the path forward for the company became clear.

“Together we said we bring the understanding of all the technology and machine learning that needs to be brought into the work and Ansu and Danny bring the single-cell biology,” said Solomon. 

Now as the company unveils itself and the $20 million in financing it has received from investors including Viola Ventures and TLV Partners, it’s going to be making a hiring push and expanding its already robust research and development activities. 

Immunai already boasts clinical partnerships with over ten medical centers and commercial partnerships with several biopharma companies, according to the company. And the team has already published peer-reviewed work on the origin of tumor-fighting T cells following PD-1 blockade, Immunai said.

“We are implementing a complicated engineering pipeline. We wanted to scale to hundreds of patients and thousands of samples,” said Wells. “Right now, in the world of cancer therapy, there are new drugs coming on the market that are called checkpoint inhibitors. [We’re] trying to understand how these molecules are working and find new combinations and new targets. We need to see the immune system in full granularity.”

That’s what Immunai’s combination of hardware and software allows researchers to do, said Wells. “It’s a vertically integrated platform for single cell profiling,” he said. “We go even further to figure out what the biology is there and figure that out in a new combination design for the trial.”

Cell therapies and cancer immunotherapies are changing the practice of medicine and offering new treatments for conditions, but given how complex the immune system is, the developers of those therapies have few insights into how their treatments will effect the immune system. Given the diversity of individual patients variations in products can significantly change the way a patient will respond to the treatment, the company said.

Photo: Andrew Brookes/Getty Images

Immunai has the potential to change the way these treatments are developed by using single-cell technologies to profile cells by generating over a terabyte of data from an individual blood sample. The company’s proprietary database and machine learnings tools map incoming data to different cell types and create profiles of immune responses based on differentiated elements. Finally, the database of immune profiles supports the disvovery of biomarkers that can then be monitored for potential changes.

“Our mission is to map the immune system with neural networks and transfer learning techniques informed by deep immunology knowledge,” said Voloch, in a statement. “We developed the tools and knowhow to help every immuno-oncology and cell therapy researcher excel at their job. This helps increase the speed in which drugs are developed and brought to market by elucidating their mechanisms of action and resistance.”

Pharmaceutical companies are already aware of the transformational potential of the technology, according to Solomon. The company is already in the process of finalizing a seven-figure contract from a Fortune 100 company, according to Solomon. 

One of the company’s earliest research coups was using research to show the way that immune systems function when anti-PD1 molecules are introduced. Typically the presence of PD-1 means that t-cell production is being suppressed. What the research from ImmuneAI revealed was that the response wasn’t happening with T-cells within the tumor. There were new t-cells that were migrating to the tumor to fight it off, according to Wells.

“This whole approach that we have around looking at all of these indications — we believe that the right way and most powerful way to study these diseases is to look at the immune system from the top down,” said Voloch, in an interview. “Looking at all of these different scenarios. From the top, you see these patterns than wouldn’t be available otherwise.” 

Lucid Lane has developed a service to get patients off of pain meds and avoid addiction

Four years ago, Adnan Asar, the founder of the new addiction prevention service Lucid Lane, was enjoying a successful career working as the founding chief technology officer at Livongo Health. It was the serial senior tech executive’s most recent job after a long stint at Shutterfly and he was shepherding the company through the development of its suite of hardware and software for the management of chronic conditions.

But when Asar’s wife was diagnosed with non-Hodgkin’s Lymphoma, he stepped away from the technology world to be with his family while she underwent treatment.

He did not know at the time that the decision would set him on the path to founding Lucid Lane. The company’s mission is to help give patients who have been prescribed medications to address pain and anxiety ways to wean themselves off those drugs and avoid addiction — and its purpose is born from the struggle Asar witnessed as his wife wrestled with how to stop taking the medication she was prescribed during her illness.

Asar’s wife isn’t alone. In 2018, there were roughly 168.2 million prescriptions for opioids written in the United States, according to data from the Centers for Disease Control and Prevention. Lucid Lane estimates that 50 million people are prescribed opioids and another 13 million are prescribed benzodiazepines each year either after surgery or in conjunction with cancer treatments — all without a plan for how to manage or taper the use of these highly addictive medications.

For Asar’s wife, it was the benzodiazepine prescribed as part of her cancer treatment that became an issue. “She was hit by very severe withdrawal symptoms and we didn’t know what was going on,” Asar said. When they consulted her physician he gave the couple two options — quitting cold turkey or remaining on the medication.

“My wife decided to go cold turkey,” Asar said. “It was really debilitating for the whole family.”

It took nine months of therapy and regular consultations with psychiatrists to help with tailoring medication dosages and tapering to get her off of the medication, said Asar. And that experience led to the launch of Lucid Lane.

“Our goal is to prevent and control medication and substance dependence,” Asar said.

The company’s telehealth solution is built on a proprietary treatment protocol meant to provide continuous daily support and interventions, along with proactive monitoring of a personalized treatment plan — all on an ongoing basis, said Asar. 

And the COVID-19 pandemic is only accelerating the need for telehealth services. “COVID-19 has made telehealth a mandatory service instead of a discretionary service,” said Asar. “There’s a surge in anxiety, depression, substance use and medication use. We’re seeing a surge of patients who are reaching out to us.”

Asar sees Lucid Lane’s competitors as companies like Lyra Health and Ginger, or point solutions building digital diagnostics to detect anxiety and depression. But unlike some companies that are launching to treat addiction or addictive behaviors, Asar sees his startup as preventing dependency and addiction.

“A lot of people are sliding into these addictions through something that happens at the doctor’s office,” said Asar. ” Our solution does not prescribe any of these medications.”

The company is working on clinical studies that are set to start at the Palo Alto VA hospital, and has raised $4 million in seed funding from investors including Battery Ventures and AME Cloud Ventures, the investment firm founded by Jerry Yang.

“We see great potential for Lucid Lane, as it has developed a scalable solution to one of the biggest problems facing society today,” said Battery general partner Dharmesh Thakker, in a statement. “Telehealth solutions have emerged as highly capable of addressing complex problems, and Lucid Lane has embraced remote care from its beginning. Its design enables care anytime, anywhere for patients in their moment of need. This can make a tremendous difference in the battle between recovery and relapse. We believe that it will help millions of people lead better lives.”

Joining Asar in the development of the company and its healthcare protocols are a seasoned team of health professionals, including Dr. Ahmed Zaafran, a board certified anesthesiologist at Santa Clara Valley Medical Center and assistant professor of anesthesiology (affiliated) at Stanford University School of Medicine; and advisors like Dr. Vanila Singh, who was also previously chairperson of the HHS Task Force in conjunction with the DOD and the VA to address the opioid drug crisis; Dr. Carin Hagberg, the chair of anesthesiology, perioperative and pain medicine of MD Anderson Cancer Center; and Sherif Zaafran, the president of the Texas Medical Board and chair of multiple national committees on pain management, including the subcommittee Taskforce on Pain Management Services for HHS, as well as the department’s Pain Clinical Pathways Committee.

“Lucid Lane provides a patient-centered solution that allows for the best clinical outcomes for patients after surgery and those bravely finishing chemotherapy,” said Dr. Singh, in a statement. “For the many patients who require short-term opioids and benzodiazepine medications, Lucid Lane’s treatment can limit the risk of prolonged dependence of these medications while also ensuring effective pain control with a resulting improved quality of life and functioning.”

Owkin raises $25 million as it builds a secure network for healthcare analysis and research

Imagine a model of collaborative research and development among hospitals, pharmaceutical companies, universities and other research institutions where no one shared any actual data.

That’s the dream of the new New York-based startup Owkin, which has raised $25 million in fresh financing from investors, including Bpifrance Large Venture, Cathay Innovation and MACSF (the French Pension Fund for Clinicians), alongside previous investors GV, F-Prime Capital and Eight Roads

The company’s pitch is that data scientists, clinical doctors, academics and pharmaceutical companies can all log in to the virtual lab that Owkin calls the Owkin Studio.

In that virtual environment, all parties can access anonymized data sets and models exclusively to refine their own research and development and studies to ensure that the most cutting-edge insights into novel biomarkers, mechanisms of action and predictive models inform the work that all of the relevant parties are doing.

The ultimate goal, the company said, is to improve patient outcomes.

In its quest to get more companies and institutions to open up and share information — with the promise that the information can’t be extracted or used in a way that isn’t allowed by the owners of the data — Owkin is replicating work that other companies are pursuing in fields ranging from healthcare to financial services and beyond.

The Israeli company Qedit has developed similar technologies for the financial services industry, and Sympatic, a recent graduate from one of the recent batches of Techstars companies, is working on a similar technology for the healthcare industry.

Owkin makes money by enabling remote access to the data sets for pharmaceutical companies and licensing the models developed by universities to those companies. It’s a way for the company to entice researchers to join the platform and provide another revenue stream for research institutions who have seen their funding decline over the last 40 years.

We have a huge loop of academic universities that have access to the data and are developing algorithms and we share data,” said the company’s chief executive Dr. Thomas Clozel. “At the end what it helps is developing better drugs.”

Declines in federal funding for scientific research since the 1980s (Image courtesy of The Conversation)

The investment from Owkin’s new and existing investors takes the company to $55 million in total capital raised through the extension of its Series A round. In all, the round totaled $52 million, Clozel said.

“We are exactly where we need to be because it’s about privacy and privacy is more important than ever before,” said Clozel.

The COVID-19 epidemic has emphasized the need for closer collaboration among different corporations and research institutions, and that has also increased demand for the company’s technology. “It touches everything… We have access to the right data sets and centers to build the best models for COVID,” said Clozel. “We’re lucky to have the right traction before the COVID happens and we have the right research that has been done.”

In fact, the company has launched the Covid-19 Open AI Consortium (COAI), and is using its platform to advance collaborative research and accelerate clinical development of effective treatments for patients infected with the coronavirus, the company said. All of its findings will be shared with the global medical and scientific communities.

The initial focus on the research is on cardiovascular complications in COVID-19 patients in collaboration with CAPACITY, an international registry working with over 50 centers worldwide, the company said. Other areas of research will include patient outcomes and triage, and the prediction and characterization of immune response, according to Owkin.

“Since we first backed Owkin in 2017, we have been sharing its vision to apply AI to fighting one of the most dreadful diseases on earth: cancer,” said Jacky Abitbol, a partner at Cathay Innovation. “Owkin has risen to become a leader in digital health, we are proud to grow our investment in the company to fuel its ambition to pioneer AI for medical research, while preserving patient-privacy and data security.”

LetsGetChecked raises $71 million as COVID-19 epidemic makes home-testing increasingly vital

As the country wrestles with the COVID-19 epidemic, home health testing, checkups and diagnostics have never been more important and companies like LetsGetChecked are filling a void left in a U.S. healthcare system consumed by the outbreak.

The surge in demand for the company’s services has led to an equal surge in investor interest, and LetsGetChecked is one of many home health and remote diagnostics companies to raise new capital during the pandemic.

The company’s new $71 million financing isn’t just about the services the company can provide during the COVID-19 epidemic. Now that an increasing number of Americans are accessing home health services, they’ll likely continue to use them thanks to their convenience and ease of use, according to LetsGetChecked chief executive, Peter Foley.

“People are very focused on COVID-19. [But] we’re seeing trends of increases in everything else,” said Foley. “This situation has definitely legitimized the space of home diagnostics. We are seeing spikes in those kinds of tests. Everything that needs monitoring we’re seeing spikes in.”

Most consumers are avoiding doctors, hospitals and clinics out of concern over the epidemic and that’s pushing them to use telemedicine and remote testing services, said Foley.

And the company has stepped up to address the coronavirus outbreak itself. The company, which has a manufacturing facility in Queens where it makes its own test kits has been unfazed by the supply chain issues that have hit other companies, said Foley. And LetsGetChecked has a certified lab facility where it can conduct its own tests.

LetsGetChecked at-home Coronavirus test kit.

Right now, the company is offering both a serological test (sourced from a Korean lab and awaiting approval by the FDA) and a PCR test (from ThermoFisher) for SARS-CoV-2 and is looking to expand the scope of its tests. The LetsGetChecked tests include a rapid (antibody) serology test for results within 15 minutes, followed by a PCR-based test which requires a swab sample to be collected from a patient and later processed within the LetsGetChecked high complexity CLIA lab in Monrovia, Calif., the company said. Initially the testing was for first responders and those most at risk from the disease, but the population that the company is testing is expanding as the spread of the virus slows.

“We were fortunate enough to be in a position where we could help people now,” says Foley.

LetsGetChecked isn’t the only startup at work developing and distributing home testing services for the coronavirus. Everlywell and Scanwell Health are two other startups that have been developing and selling home test kits as well.

LetsGetChecked began fundraising four months ago, and even then, in the days before COVID-19 hit American shores, the environment for raising capital had tightened, Foley said.

In the days before the disease reached epidemic proportions in the U.S. LetsGetChecked was pitching its ability to test at-home or through partner retailers for cancer screening, sexual health, fertility and pharmacogenomic testing.

Users can buy tests and collect samples at home before sending them to LetsGetChecked’s facility. The company connects its customers to board-certified physicians to discuss abnormal results and determine a course of action for treatment

The company’s initial pitch and the promise of a vast remote diagnostics market was enough to convince Illumina Ventures, which co-led the round with HLM Venture Partners. Other new investors included Deerfield, CommonFund Capital, and Angeles Investment Advisors. Previous investors Transformation Capital, Optum Vnetures, and Qiming Venture Partners USA also participated.

For Illumina Ventures, the LetsGetChecked remote testing service can serve as a channel for some of the tests under development at the firm’s other healthcare portfolio companies, according to Nick Naclerio, a founding partner at Illumina Ventures and a new director on the LetsGetChecked board.

“A lot of companies developing cutting edge new tests have challenges building a channel into the broader market,” said Naclerio. “Here is a company going after building the kind of future, patient-initiated testing channel that the world needs and is probably synergistic with some of the companies that are doing next generation testing.”

Those would be companies like Serimmune, which is developing tests to map the human immune system, or Genome Medical, which applies the latest understanding of the human genome to treatments for patients. The firm also has investments in cancer screening companies like Grail, which is aiming to provide an early detection diagnostic for cancer.

Naclerio also sees a dramatic shift in consumer behavior on the horizon in the post-COVID-19 world.

“COVID presents a tremendous need for at-home infectious disease testing or at-work infectious disease testing,” he said. “This is breaking down a lot of the barriers that have historically slowed the adoption of telehealth… It creates an opportunity for LetsGetChecked even once we get over the peak of the curve. There’s going to be a lasting impact.”

NEA-backed Personal Genome Diagnostics receives FDA clearance for its cancer diagnostic

Personal Genome Diagnostics, the venture-backed developer of a novel diagnostic kit for genomic profiling of different cancers in lab settings, has received clearance from the U.S. Food and Drug Administration for its PGDx elio tissue complete test.

The test’s approval is another step forward for precision therapies that rely on an understanding of the unique genomic profile of an individual patient’s tumor, according to the company.

The test detects single nucleotide variants and the small insertions and deletions known as indels. Single nucleotide variants, indels, and identifying characteristics like the tumor mutation burden can be used by physicians to determine how rapidly a disease like cancer to progress and can provide essential targets for precision therapies to individual tumors.

The information doctors collect from these tests can also be used to help oncologists identify patients for clinical trials.

The new diagnostics test cover 35 different tumor types.

“There has not, until this point, been one standardized test for all kinds of cancer that any lab across the country can perform,” said Dr. Pranil Chandra, Chief Medical Officer of Genomic and Clinical Pathology Services, PathGroup, an early collaborator for PGDx elio tissue complete, in a statement. “With this clearance, labs across the country will for the first time have an option for a regulated, standardized test that examines a broad view of cancer pathways and genomic signatures across advanced cancers.”

To date, Personal Genome Diagnostics has raised over $99 million, according to Crunchbase. The company’s investors include New Enterprise Associates, Bristol Myers Squibb, Inova Strategic Investments, Co-win Healthcare Fund, Helsinn Investment Fund, Windham Venture Partners, Maryland Venture Fund

“We are proud to have led the first institutional round for PGDx,” said Dr. Justin Klein, in a statement when the company raised a $75 million round back in 2018. “Rapid advances in immuno-oncology, targeted agents, and combination cancer therapies are heightening the importance of tumor genome testing that enables treatments to be targeted to those patients most likely to benefit.”

 

Venture-backed Celularity receives FDA approval for early trials of a new cell therapy for COVID-19

Celularity, the venture-backed developer of novel cell therapies for cancer treatments, has received an initial clearance from the Food and Drug Administration to begin early-stage clinical trials on a potential treatment for COVID-19.

The company, which has raised at least $290 million to date (according to Crunchbase), uses “Natural Killer” (NK) cell therapies to boost the immune system’s disease-fighting response.

For Celularity, those NK cells are derived from stem cells cultivated from placental tissue, which hospitals typically treat as medical waste.

Backed by the venture investment firm Section 32, and strategic investors including Celgene, now a division of Bristol Myers; United Therapeutics, a biomedical technology developer; Human Longevity, the troubled venture-backed startup founded by genomics J. Craig Venter; and Sorrento Therapeutics, a publicly traded biomedical company; Celularity was pursuing a number of applications of the novel cell therapy, but its initial focus was on cancer treatments.

The real breakthrough for the company, and one of the reasons why it’s attracted so much capital, is that its cell therapies don’t need to be cultivated from a patient donor — a lengthy and expensive process. Celularity is able to produce NK cells and store them, so that they can be ready for transfusion when they’re needed.

With the the FDA’s clearance, Celularity is going to begin a small, 86-person trial to test the efficacy of its CYNK-001 immunotherapy to treat COVID-19 infected adults, the company said.

There are at least two studies underway in China that are also testing whether Natural Killer cells can be used to treat COVID-19.

NK cells are a type of white blood cell that are part of the body’s immune system. Unlike t-cells, which target particular pathogens, NK cells typically work to support the immune system by identifying and destroying cells in the body that appear to be stressed, either from an infection or a mutation.

The therapy seems to be successful in treating certain types of cancer, and the company’s researchers speculate that it can provide similar results in stopping the ability of the novel coronavirus which causes COVID-19 to spread throughout the body.

However, there are some potential roadblocks and risks to pursuing the NK therapy. Chiefly, COVID-19 is deadly in part because it can push the immune system into overdrive. The “cytokine storm” that results from the infection means that the body starts attacking healthy cells in the lungs which leads to organ failure and death. If that’s the case, then boosting the immune response to COVID-19 might be dangerous for patients.

There’s also the possibility that NK cells might not be able to detect which cells are infected with the coronavirus which causes COVID-19, rendering the therapy ineffective.

“Studies have established that there is robust activation of NK cells during viral infection regardless of the virus class,” said Celularity’s Chief Scientific Officer, Xiaokui Zhang, in a statement. “These functions suggest that CYNK-001 could provide a benefit to COVID-19 patients in terms of limiting SARS-CoV-2 replication and disease progression by eliminating the infected cells.”

Karius raises $165 million for its liquid biopsy technology identifying diseases in a drop of blood

“What Karius is good at is identifying those novel microbes before they become an outbreak like coronavirus,” says Mickey Kertesz, a chief executive whose life sciences startup just hauled in $165 million in new funding.

While the new money may have been raised under the looming threat of Covid 19, the company’s technology is already being used to test for infection-causing pathogens in immunocompromised pediatric patients, and for potential causes of complex pneumonia, fungal infections and endocarditis, according to a statement from the company. 

Liquid biopsy technology has been widely embraced in cancer treatments as a way to identify which therapies may work best for patients based on the presence of trace amounts of genetic material in a patient’s bloodstream that are shed by cancer cells.

Karius applies the same principles to the detection of pathogens in the blood — developing hardware and software that applies computer vision and machine learning techniques to identify the genetic material that’s present in a blood sample.

As the company explains, microbes infecting the human body leave traces of their DNA in blood, which are called microbial cell-free DNA (mcfDNA). The company’s test can measure the that cell free DNA of more than 1,000 clinically relevant samples from things like bacteria, DNA viruses, fungi, and parasites. These tests indicate the types of quantities of those pathogens that are likely affecting a patient. 

“We’re through the early stages of adoption and clinical studies show that the technology literally saves lives,” says Kertesz.

Its early successes were enough to attract the attention of SoftBank, which is backing the company through capital raised for its second Vision Fund.

While SoftBank has been roundly criticized for investing too much too soon (or too late) into consumer startups which have not lived up to their promise (notably with implosions at Brandless, Zume, and the potential catastrophe known as WeWork), its life sciences investing team has an impressive track record. “They have the experience and the expertise and the network that’s very relevant to us,” Kertesz said of the decision to take SoftBank’s money. “That’s the team that was on the board of Guardant Health [and] 10X Genomics.”

Both of those companies have proven to be successful in public markets and with validated technology. That’s a feature which Karius shares. The company’s published an analytical and clinical validation of its test in the peer-reviewed journal, Nature Microbiology showing that its test identified the likely pathogens causing an infection when compared to standard methods more quickly and more accurately. 

With initial validation behind it, the company raised its new cash to pursue rapid commercial adoption for its tests and to continue validating applications of its technology while exploring new ones.

Among the primary areas of exploration is the identification of new biomarkers, which could serve as indicators for new diseases (like Covid 19).

“As humanity we haven’t figured out infectious diseases yet,” said Kertesz. “Specifically at the stage where the pathogen is identified.” Karius has the technology to do that — although it doesn’t yet have the capability to screen for RNA viruses (which are types of diseases like SARS and the coronavirus), Kertesz said. “It’s the only type of virus that the platform is unable to detect… [We’re] adding that detection capability.” 

Karius works by digitizing the microbial information in a blood sample and uses machine learning and computer vision to recognize the microbial signatures. The company uses public databases which have records of over 300,000 pathogens. For the ones that the company can’t identify, it creates a identifier for those as well. “One of the biggest challeges we have here is to know what we don’t know,” said Kertesz.

At $2,000 per test, Karius’ biopsies aren’t cheap, but they’re safer and more cost effective than surgeries, according to Kartesz. It’s obviating the need to dig into a patient for a piece of tissue and the technology is already being used in over 100 hospitals and health systems, the company said.

With that kind of reach new investors including General Catalyst and HBM Healthcare Investments were willing to sign on with SoftBank’s Vision Fund and previous investors like Khosla Ventures and LightSpeed Venture Partners to participate in the latest round.

“Infectious diseases are the second leading cause of deaths worldwide. Karius’ innovative mcfDNA technology accurately diagnoses infections that cannot be determined by other existing technologies,” said Deep Nishar, Senior Managing Partner at SoftBank Investment Advisers, in a statement.

 

LabCorp website bug exposed thousands of medical documents

A security flaw in LabCorp’s website exposed thousands of medical documents, like test results containing sensitive health data.

It’s the second incident in the past year after LabCorp said in June that 7.7 million patients had been affected by a credit card data breach of a third-party payments processor. The breach also hit several other laboratory testing companies, including Quest Diagnostics.

This latest security lapse was caused by a vulnerability on a part of LabCorp’s website, understood to host the company’s internal customer relationship management system. Although the system appeared to be protected with a password, the part of the website designed to pull patient files from the back-end system was left exposed. That unprotected web address was visible to search engines and was later cached by Google, making it accessible to anyone who knew where to look. The cached search result only returned one document — a document containing a patient’s health information. But changing and incrementing the document number in the web address made it possible to access other documents.

The bug is now fixed.

Using computer commands, we determined the approximate number of exposed documents by asking the exposed server if a document existed by returning certain properties about the file — such as its size — but not the document itself. This allowed us to see if a document was on the server without accessing large amounts of patient information, and thus preventing any further exposure to the patient’s privacy.

The results showed at least 10,000 documents were exposed.

Of the handful of files we examined to understand what kind of data was exposed, the documents largely appeared to affect cancer patients under the laboratory’s Integrated Oncology speciality testing unit.

The documents contained names, dates of birth, and in some cases Social Security numbers of patients. The documents also contained lab test results and diagnostic data, a class of data considered protected health information under the Health Insurance Portability and Accountability Act (HIPAA). A couple of the documents we reviewed contained a footer notice, which said: “This document contains private and confidential health information protected under state and federal law.”

Running afoul of HIPAA can result in heavy fines.

“This is a massive privacy issue — and one that could impact affected users and patients for years to come,” said Rachel Tobac, a hacker, social engineer, and founder of SocialProof Security. “The sensitive nature of those documents and the leak of private medical status is a huge privacy violation for those patients for obvious reasons, but also sadly for some possibly less glaring reasons, as well.”

Tobac, who reviewed our findings, said medical information can be “terribly useful” for criminals in identity theft, extortion, and phishing, because the victim may be more likely to trust the sender “under the assumption that the message is legitimate because it contains information only their medical provider could or should know.”

The vulnerability was found in-house at TechCrunch and was reported to LabCorp, which later pulled the server offline. Although the web address remains in Google’s search results, the link is now dead.

“I can confirm that we have terminated access to the system,” said LabCorp spokesperson Donald Von Hogan. But the company would not ay if it planed to inform patients and state authorities under data breach notification laws to the security lapse.

LabCorp’s Von Hogan said in a call that the company would not confirm the documents found on the exposed server “are in fact LabCorp information.”

TechCrunch reached out to a number of patients to verify their information. Only one person confirmed by phone that the information in their exposed file was accurate, but expressed that they did not want to be named for this story.

Two other people whose names were in the files had since passed away, according to obituaries.

LabCorp website bug exposed thousands of medical documents

A security flaw in LabCorp’s website exposed thousands of medical documents, like test results containing sensitive health data.

It’s the second incident in the past year after LabCorp said in June that 7.7 million patients had been affected by a credit card data breach of a third-party payments processor. The breach also hit several other laboratory testing companies, including Quest Diagnostics.

This latest security lapse was caused by a vulnerability on a part of LabCorp’s website, understood to host the company’s internal customer relationship management system. Although the system appeared to be protected with a password, the part of the website designed to pull patient files from the back-end system was left exposed. That unprotected web address was visible to search engines and was later cached by Google, making it accessible to anyone who knew where to look. The cached search result only returned one document — a document containing a patient’s health information. But changing and incrementing the document number in the web address made it possible to access other documents.

The bug is now fixed.

Using computer commands, we determined the approximate number of exposed documents by asking the exposed server if a document existed by returning certain properties about the file — such as its size — but not the document itself. This allowed us to see if a document was on the server without accessing large amounts of patient information, and thus preventing any further exposure to the patient’s privacy.

The results showed at least 10,000 documents were exposed.

Of the handful of files we examined to understand what kind of data was exposed, the documents largely appeared to affect cancer patients under the laboratory’s Integrated Oncology speciality testing unit.

The documents contained names, dates of birth, and in some cases Social Security numbers of patients. The documents also contained lab test results and diagnostic data, a class of data considered protected health information under the Health Insurance Portability and Accountability Act (HIPAA). A couple of the documents we reviewed contained a footer notice, which said: “This document contains private and confidential health information protected under state and federal law.”

Running afoul of HIPAA can result in heavy fines.

“This is a massive privacy issue — and one that could impact affected users and patients for years to come,” said Rachel Tobac, a hacker, social engineer, and founder of SocialProof Security. “The sensitive nature of those documents and the leak of private medical status is a huge privacy violation for those patients for obvious reasons, but also sadly for some possibly less glaring reasons, as well.”

Tobac, who reviewed our findings, said medical information can be “terribly useful” for criminals in identity theft, extortion, and phishing, because the victim may be more likely to trust the sender “under the assumption that the message is legitimate because it contains information only their medical provider could or should know.”

The vulnerability was found in-house at TechCrunch and was reported to LabCorp, which later pulled the server offline. Although the web address remains in Google’s search results, the link is now dead.

“I can confirm that we have terminated access to the system,” said LabCorp spokesperson Donald Von Hogan. But the company would not ay if it planed to inform patients and state authorities under data breach notification laws to the security lapse.

LabCorp’s Von Hogan said in a call that the company would not confirm the documents found on the exposed server “are in fact LabCorp information.”

TechCrunch reached out to a number of patients to verify their information. Only one person confirmed by phone that the information in their exposed file was accurate, but expressed that they did not want to be named for this story.

Two other people whose names were in the files had since passed away, according to obituaries.