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News Article | August 2, 2017
Site: www.wired.com

The collapse of the diagnostic company Theranos shook the world of venture-funded biotechnology. Theranos was a “unicorn,” valued by its investors at $9 billion at one point. That made its founder, Elizabeth Holmes, the youngest woman billionaire in the world for inventing a technology that, she said, allowed pharmacies and doctors’ offices to do a bunch of medical diagnostic tests on a single drop of a person’s blood. Crushing investigative journalism , led by the Wall Street Journal’s John Carreyou, showed that Theranos’ enabling technology didn’t work. The company’s value zeroed out and the Centers for Medicare and Medicaid Services banned Holmes from laboratory work. The rise-fall narrative rang loudly in the worlds of health care, medical device technology, and the investment firms increasingly funding hunts for nominally disruptive, Silicon Valley-style solutions to longstanding medical problems. Like the Wizard said: What did you learn, Dorothy ? At the Innovation Pipeline conference on Tuesday—put on by The Atlantic in San Francisco—a panel of biotech investors and executives sounded like they were still stunned, but hellbent on making sure they don’t get burned again. There, one of the panelists was Cary Gunn, the president, CEO, and founder of Genalyte, a company that says it can do 128 diagnostic blood tests on just one drop of blood in just a few minutes. That’s an elevator pitch that you might think would raise some red flags in light of well, you know . And it did . But it also garnered a $36 million investment from, among other places, Khosla Ventures. So Gunn bravely set out to defend Theranos—to a point. “Decentralizing diagnosis and getting the data into doctors’ hands a lot faster” is still a good idea, he said. “We’re just going to do it right.” Genalyte researchers have presented initial data at conferences and announced plans to carry out more human studies and publish the results. Theranos was notoriously cagey with its data . That seems to have been at least one takeaway: VCs are asking to see results first. “We haven’t done a single financing round without having to show data on our assay,” said Gabe Otte, CEO and co-founder of Freenome, another diagnostics company. “That’s largely been because of Theranos. They were able to raise hundreds of millions of dollars without showing data.” The company didn’t have to , regulatorily speaking. And if future companies do, it’ll be because of economic incentives like funding, unless the laws change. Lynn Seely, president and CEO of Myovant Sciences—currently in phase III trials of a drug for heavy menstrual bleeding and uterine fibroid pain, with what Forbes called the biggest biotech IPO of 2016 —suggested that whatever changed in venture capital and biotech, Theranos had tarred the field. “Two out of three times on a plane, when I tell someone what I do, the next comment is, ‘Theranos’,” Seely said. She added that it was “sad” that the scandal happened to a woman. The implication was that Holmes’ gender might make it even less likely for woman-led companies to get funding. Absent data, maybe investors and the media should’ve showed more skepticism from the start. People have touted the concept of a single-drop blood test for years. “The idea that maybe some people working on a problem in a garage have been able to do it overnight may not be true,” said Sean Harper, the executive VP of research and development at the drug giant Amgen. If due diligence wasn’t the norm at venture capital companies, maybe now it will be—if there's a return on that investment. Diagnostics, as a field, is a money-saver in terms of public health, but looks a lot less profitable without the kind of business model Theranos promised. Expensive, high-tech drugs, though? “There’s no multi-billion-dollar exits in diagnostics,” Gunn said. “There are in therapeutics.” Maybe what Theranos really revealed was a structural flaw in the way medical tech gets funded. Self-awareness about that company’s collapse was on display at the conference, but whether Silicon Valley will change is still in play.


News Article | November 10, 2016
Site: www.newsmaker.com.au

Cancer is characterized by the growth of abnormal cells that divide uncontrollably and have the ability to infiltrate and destroy normal body tissue. Cancer is triggered by both external factors such as tobacco, chemicals, alcohol, infectious organisms, sun exposure and internal factors such as hormones, inherited gene mutations, immune conditions and abrupt mutations. Cancer can start almost anywhere in the human body and has the ability to spread all over the body. Cancers are majorly solid tumors (tissue masses) and blood cancers (leukemia). There are more than 100 types of cancers such as lung cancer, colorectal, breast, blood cancers, etc. Cancer is the second-leading cause of death in the United States. But survival rates have improved for many types of cancer due to continuous development of screening and treatment procedures. The most common cancer diagnostic methods are biopsy, sentinel node biopsy, endoscopy, blood tests, bone marrow aspiration, Pap test, sputum and bronchial washing analysis, imaging studies, genetic analysis, etc. The diagnosis of cancer involves collection of patient samples such as a cell or tissue or cells’ proteins, DNA, and RNA followed by detection of specific cancer. Cancer diagnostics market is witnessing high growth due to increasing prevalence and incidences of several types of cancers. Major drivers for the global cancer diagnostic market are technologically advanced and increasing point-of-care diagnostics, cost-effective treatment modalities, and personalized medicine. Additionally, increasing persistence to provide best-in-class healthcare services with high accuracy and efficiency towards patient is expected to fuel the global cancer diagnostics market across the globe. However, lack of adequate reimbursement policies for novel technologies and stringent regulatory procedures particularly for United States are the major factors that can hamper the global cancer diagnostics growth over the forecast period. The global cancer diagnostics market has been classified on the basis of product, application, end use and geography. Based on product type, the global cancer diagnostics market is segmented into the following: Based on application type, the global cancer diagnostics market is segmented into the following: Based on end use type, the global cancer diagnostics market is segmented into the following: North America was the key region in global cancer diagnostics market in terms of revenue in 2014, followed by Europe. The first FDA-cleared assay for breast cancer diagnosis was In Vitro Diagnostic Multivariate Index Assays (IVDMIA). The "MammaPrint" and “BluePrint” assays for breast cancer diagnosis and a microarray-based gene expression assay "ColoPrint" for predicting the recurrence of stage II and III colon cancer, has recognized the potential of cancer/tumor profiling in diagnostics and prognosis. This scenario is anticipated to revolutionize the cancer diagnostics companies and boost growth in global cancer diagnostics market in the coming five to 10 years.  By product type, genomic biomarkers are dominating as compared to other product types in global cancer diagnostics market. For instance, GUARDANT360 blood test, next generation sequencing test 'Cologuard', Cobas HPV Test, and myRisk Hereditary Cancer multigene molecular diagnostic test are few examples of genomic biomarkers. By end use, hospitals and diagnostic centres segments held 50% share in the global cancer diagnostic market and the trend is forecast to continue through 2025. The altering regulatory consequences among the high growth countries of Asia Pacific is attracting the leading companies in the global cancer diagnostics market. Key players of cancer diagnostics market are M Genomics Ltd., Abbott Laboratories,  Agena Bioscience Inc., Alere Inc., Astra Biotech GmbH, bioMérieux SA, BioMosaics, Biotype Diagnostic GmbH, Cancer Genetics, Inc., CDx Diagnostics, Celerus Diagnostics, Inc., Cube Dx GmbH, Dako A/S (an gilent company), EntroGen, Inc., Epigenomics AG, Exact Sciences Corporation, GE Healthcare, Genalyte, Inc., GeneCentric Diagnostics, Inc., GeneDx,., Genomic Vision, Genoptix (a Novartis company),  Hologic, Inc., Illumina, Inc., Inform Genomics, Inc., Mayo Medical Laboratories and Mayo Clinic, MBL International Corporation, NanoIVD, Inc., NanoString Technologies, Inc., NewGene Ltd., OncoPlex Diagnostics (OncoPlexDx), Oncospire Genomics, Oxford Cancer Biomarkers Ltd., Oxford Gene Technology, PrognosDx Health, Inc., Provista Diagnostics, Inc., QuantuMDx Group, Quest Diagnostics, Rheonix, Inc., Rosetta Genomics Ltd., Siemens Healthcare Diagnostics, Thermo Fisher Scientific, Inc., Transgenomic, Inc., TrimGen Corporation, TrovaGene, Inc., Ventana Medical Systems, Inc. Getting regulatory approvals for in vitro cancer diagnostics in Europe is easy as compared to United States. So preferably most of the cancer diagnostic companies are launching their new innovative products in Europe and consequently applying for FDA in the United States.


Owen T.,University of California at Santa Barbara | Owen T.,Genalyte, Inc. | Butler A.,University of California at Santa Barbara
Coordination Chemistry Reviews | Year: 2011

This review covers selected surfactant ligands that undergo a change in aggregate morphology upon coordination of a metal ion, with a particular focus on coordination-induced micelle-to-vesicle transitions. The surfactants include microbially produced amphiphilic siderophores, as well as synthetic amphiphilic ligands. The mechanism of the metal-induced phase change is considered in light of the coordination chemistry of the metal ions, the nature of the ligands, and changes in molecular geometry that result from metal coordination. Of particular interest are biologically produced amphiphiles that coordinate transition metal ions and amphiphilic ligands of relevance to bioinorganic chemistry. © 2010 Elsevier B.V.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 523.48K | Year: 2012

DESCRIPTION (provided by applicant): Genalyte will demonstrate the feasibility of our bio-sensing instrument platform for rapid sensitive high- throughput and low cost multiplexed panels to identify and monitor immune status for Type 1 Diabetes (T1D) auto-antibodies. The key to this capability is a proprietary label-free sensor based on silicon photonics chip technology. This sensor array is low cost, compact, mass manufacturable, and sensitive. Coupled with a real-time scanning instrumentation, specimensof serum (typically 25 L) are sampled from a 96 well plate and introduced to the chip where they are read immediately, with simultaneous results for up to 128 analytes. The goal of this application is to devise and generate a novel multiplex assay for thedetection and profiling of autoantibody responses associated with T1D. A two tier approach will involve first creating a basic multiplex assay to detect autoimmune response for known targets for T1D. Second, we will explore the analytical capability of thesystem with an expanded multiplexing to epitope map antibody binding across regions of the antigen as well as developing methods to assess autoantibody affinity. The ability to profile autoantibody response by multiple criteria will enhance our ability todetect and monitor disease development. PUBLIC HEALTH RELEVANCE: Project Narrative Genalyte has developed a novel bio-sensing instrument platform for rapid, sensitive, high-throughput, low cost, analysis of blood proteins, requiring minimal sample preparation. We propose to use this to generate a novel, multiplexed assay for T1D that will measure autoantibody load, target specificity, and affinity, as a means to profile immune response through the course of disease progression.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 199.94K | Year: 2011

"Rapid Multiplexed Detection of Cancer Related Proteins" The contractor will utilize a multiplexed label-free platform developed by the contractor with potential to realize sensitive and high-throughput analysis of proteins in clinical samples. This technology will be used throughout the contract to demostrate how it can be used for cancer marker screening.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 999.24K | Year: 2013

A technology that enables the analysis of many proteins from a single drop of blood, rapidly and accurately has been developed. The instrumentation has been fully developed and launched as a commercial product. Initial applications have been developed in the field of autoimmune disease. In this project, it is proposed to apply the same methodology to detect autoimmune responses to cancer antigens. This product will be a powerful tool for researchers to detect and characterize tumor associated autoimmune response through disease progression, in a highly qualified automated and standardized instrument workflow. This will enable direct comparisons of data to be made by researchers across the country. PUBLIC HEALTH RELEVANCE


SAN DIEGO, Nov. 7, 2016 /PRNewswire-USNewswire/ -- Genalyte Inc. an emerging clinical diagnostics company, will present the first-ever clinical abstracts for the Maverick™ Detection System at the 2016 American College of Rheumatology/ Association of Rheumatology Health Professionals...


News Article | November 21, 2016
Site: www.prnewswire.com

SAN DIEGO, Nov. 21, 2016 /PRNewswire-USNewswire/ -- Genalyte, Inc. announced today that the company has raised an additional $36 million in its latest financing round, led by Khosla Ventures and Redmile Group. The San Diego based biotech company is transforming the physician-patient...


SAN DIEGO, Nov. 12, 2016 /PRNewswire-USNewswire/ -- Genalyte Inc. an emerging clinical diagnostics company, today released the first-ever clinical abstracts for the Maverick™ Detection System, demonstrating the potential for the diagnostics system to be used in a near patient setting to...


News Article | November 10, 2014
Site: gigaom.com

Ebola is still on a tear in three West African nations: the World Health Organization now estimates that while nearly 5,000 deaths have been reported, another 5,000 could be missing from the count, and more money is starting to find its way toward better healthcare infrastructure and an Ebola vaccine. From Facebook’s recently-unveiled initiative, which includes a “donate” button at the top of every newsfeed, to President Obama’s $6 billion emergency funding request, there is now a larger, more concerted effort to tackle the epidemic at its source. Beyond building infrastructure and vaccines, however, is the race to engineer a faster Ebola test. The current gold standard used by the Centers for Disease Control and Prevention is called a real-time RT-PCR assay (RT stands for reverse transcription and PCR for polymerase chain reaction), which is a way of detecting a targeted DNA molecule by amplifying it, often with fluorescent dyes, to be able to detect a virus in even tiny quantities. Specimens are often sent to the CDC or WHO (the Dallas samples were sent to Austin, Texas), often adding a travel day to the two to six hours it tends to take to get a result. The tests are considered to be highly accurate, but they’re slow, cost $100 a pop, and require a tube of blood. In places like Liberia, however, where patients finding their way to clinics are presenting acute symptoms like high fevers and vomiting, the tests don’t necessarily need to be the most sensitive given the viral load is likely high. They need to be fast, especially as the number of cases continues to grow and the current system, which requires sending tubes of blood to one of a handful of testing centers, is already backlogged. Even better if the tests also cross-check for other possible (and in some places more likely) causes, like malaria and Lassa fever. “People are waiting four to five days” for test results, Dr. J. Daniel Kelly, who is working in Sierra Leone for the aid group Wellbody Alliance, told the New York Times. “They are watching people around them die. Horrible experience. You are locked in there at night.” Researchers at Harvard say they’re making progress with a test that delivers results in under an hour, while another team in France says it’s working on a test that could give results in as few as 15 minutes, and could be ready for prime time in early 2015. And in San Diego, the company Genalyte says its test takes just 10 minutes and will be ready in early 2015 as well, providing it can jump through all the regulatory hoops and hurdles that fast. “In the United States, we need an early detection test, to test everyone this person came into contact with, and we throw millions of dollars at every case,” Dr. Cary Gunn, the founder and CEO of Genalyte, told me. “But that’s not going to happen in the third world, and the place you have to solve this is in the third world.” Many groups, including the World Health Organization, are encouraging the speedy development of rapid tests, and the Food and Drug Administration is giving emergency authorization to push qualified tests to market. (One test, BioFire’s Defense FilmArray, was just approved this way. While it is a faster, accurate one-hour PCR test, it still requires being transported to other sites, which takes up the bulk of the time lag.) While some worry this is creating a bit of a Wild West atmosphere as researchers rush to get their tests approved, some of which may be far inferior to others, there is a silver lining: It could be a matter of weeks before we see a faster, more affordable screening tool deployed to clinics throughout Liberia, Guinea, and Sierra Leone. For the most part, the tech is old school. Many faster tests use lateral flow strips (think of a pregnancy test) where antibodies bind to an Ebola virus protein. All that’s required is a finger prick of blood on the strip and a tube with a solution that reveals a line if the virus is present. These tests can take as few as 15 minutes, but like home pregnancy tests, they’re not nearly as accurate. In the case of Ebola, false positives could place people without Ebola in contact with other infected patients, while false negatives could release Ebola patients back into the public. Genalyte’s $10 10-minute finger prick test developed in San Diego (with the cost of hardware comparable to BioFire’s) is unique. Unlike the lateral flow approach – which Gunn likens to developing film: “there’s a lot of funky chemistry to make them work and timing is finicky” – Genalyte has spent seven years developing a totally new approach. By placing an array of sensors on one tiny silicon chip, it is able to avoid the many manual (and thus variable and messy) steps involved in sample prep that comprise the bulk of testing time. “It’s like developing a black and white photograph in a dark room – it’s not until the very end that you know whether or not that test worked,” Gunn said. “We’re like a digital movie. We are reading the test constantly. We get a movie of each test happening, so you’re able to see everything happen in real time. There’s no chemistry involved. It’s just straightforward watching the compounds and we see that binding happen directly. So it’s a fundamental new diagnostic technology.” Eliminating the sample prep, Gunn said, is “revolutionary” – and it should be able to test not just for Ebola, but for all types of infectious disease (including influenza), as well as allergy testing and autoimmune testing. Gunn’s approach seems to be so promising that he said even the FDA is cooperating. “I spend most of my life throttled by the FDA and complaining about them and talking about how I could get diagnostic tests out quicker if not for them, however in this case they’ve been amazing to work with so far.” Genalyte’s Ebola test could be ready for prime time – and fast-tracked for FDA approval – by early 2015. Gunn also hopes to add the simultaneous screening of other viruses and parasites, like Lassa fever and malaria, as quickly as possible. Stay tuned.

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