DxDevices

3.16.22

By Mike Smith

Liquid biopsy is a very cool technology that I first encountered in 2014 while working on a project. Since then, the market for this very broad and varied family of molecular diagnostics for cancer has grown dramatically, according to the market analysts at Transparency Market Research (MRT), which has made this market prognosis in a new report they are selling.

According to MRT “Liquid Biopsy” is defined as

A minimally invasive test to assess cancer genetic status based on the analysis of circulating biomarkers that are present in the plasma component of the blood. Liquid biopsies are majorly utilized in the field of oncology. Liquid biopsy can improve and/or resolve several inherent problems found with current cancer treatment, enabling early cancer detection, mutation detection, tumor monitoring during treatment, and recurrence monitoring via a non-invasive blood draw. In addition to being non-invasive, liquid biopsies have the potential to detect cancer before substantial tumor formation, assess multiple mutations within the tumor (reducing heterogeneity concerns), quantitatively monitor treatment progress, and identify new mutations as they emerge as well as monitor for recurrence to detect cancer before imaging-detectable tumor formation or metastasis. In addition to oncology, liquid biopsies are applicable in prenatal testing and transplant care.

MRT estimates that this global market growth is more than a 100 percent increase from the global market total of $3.9 billion in 2017. The market leaders include: Biocept, Inc., MDxHealth, Myriad Genetics, Inc., Bio-Rad Laboratories, QIAGEN, F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Genomic Health, Inc., and Illumina, Inc. However, there are hundreds of others innovating in this space, including many that are well funded.

In addition to extensive clinical and research use, liquid biopsies also provide physicians significant insights into the molecular profile of cancers, which allows clinicians to tailor chemotherapeutic treatments to the unique disease details of each patient.

MRT adds that the preference for minimally invasive procedures and the constant need for faster test result has fueled the rapid growth of this market. “Furthermore, rise in awareness regarding this procedure, benefits of simple blood draw, better therapeutic target identifications, and favorable government initiatives are also driving the global liquid biopsy market on to a higher growth curve,” according to MRT. “Additionally, it is also worth noting here that number of people suffering from cancer is growing steadily.” Neary 10 million deaths globally in 2018 are attributed to cancer.

The clinical and investment world began to take notice of liquid biopsy science in 2018 when Illumina-backed biotech startup GRAIL Inc. launched a 120,000-patient clinical trial for its next-generation sequencing test platform for the early detection of breast cancer. The test was called Galleri and GRAIL had raised $1 billion in VC funding for the trial. In late 2020, Illumina bought the startup outright for $7.1 billion. At that time, Illumina told the Wall Street Journal that it expected the global liquid biopsy market to hit $75 billion by 2035.

According to GRAIL: “The Galleri test has shown the ability to detect multiple types of cancers through a single blood draw. Most of these cancers cannot be detected through current screening paradigms. When cancer signal was detected, the Galleri test localized the cancer signal with high accuracy, helping inform next steps to diagnosis. The Galleri test is intended to be complementary to, and not a replacement of, U.S. guideline-recommended cancer screening.”

The MRT liquid biopsy report would be a fascinating read, but it costs $5,795,00, which is probably a good investment for a well-funded liquid biopsy startup, but not for a lab rat like me.

11.22.20

By Phil Washington

Progenity, Inc. reported clinical verification data for its Preecludia™ preeclampsia rule-out laboratory-developed test currently in development. With its performance data, including an observed 98.2% NPV, Progenity believes the Preecludia test has the potential to become the first tool of its kind in the United States to help triage possible preeclampsia, a potentially deadly condition for both pregnant mothers and their babies.

Preeclampsia is the second most common cause of maternal mortality, and more than 700,000 women present each year with signs and symptoms of possible preeclampsia. It is characterized as a hypertensive disorder, but it is difficult to differentiate from other hypertensive conditions in pregnancy, making diagnosis and management difficult. Ultimately, left undiagnosed and improperly managed, preeclampsia can result in impaired organ function, seizures, stroke, and death in the mother, and may require pre-term delivery of the baby. This can result in both poor health outcomes and significant costs. The total available U.S. market for a high NPV rule-out test for preeclampsia is forecasted at up to $3 billion, and there is also a large potential global opportunity.

The Preecludia test is being developed to serve as a potential triage and rule-out test to help providers differentiate between patients with symptoms who are at risk for preeclampsia. This proprietary test is a multi-analyte protein biomarker assay which is designed to be run from a simple blood draw.

In the prospective, blinded PRO-129 clinical verification study, samples were collected and analyzed from over 400 pregnant women with substantial diversity, gathered from 24 U.S. clinical sites comprised of predominantly OBGYN and Maternal Fetal Medicine (MFM) practices. Subjects presented with possible signs and symptoms of preeclampsia, including new onset hypertension, but no clear diagnosis.

Subject data were independently adjudicated by a third party, and subjects, for whom preeclampsia was not diagnosed at the time of enrollment, were followed longitudinally through delivery. In subjects sampled up to 37 weeks’ gestational age, the Preecludia test showed an 88.0% sensitivity, 73.3% specificity, and NPV of 98.2% at a 10% prevalence to rule out a patient’s risk of developing preeclampsia within the next 14 days from the date of specimen collection. These data were generally consistent with previous results observed in the test’s feasibility and optimization studies.

“The Preecludia test is the first of its kind in the United States designed to help physicians better triage symptomatic patients with suspected preeclampsia,” said Harry Stylli, PhD, CEO, chairman, and co-founder of Progenity. “It is tragic that we continue to use 19th century tools to evaluate pregnant women for diseases in the 21st century. We believe there is an obvious unmet need for new and better tools to aid in the triage, diagnosis, and management of preeclampsia. This milestone represents an important step toward our objective to commercialize the Preecludia test in the second half of 2021 and satisfy that unmet need.”

10.20.20

By Phil Washington

bioLytical Laboratories has begun the European marketing of a new one-minute antibody test for COVID-19 following the notification of CE approval, which signifies the product meets European safety standards.

Approval of the INSTI® COVID-19 Antibody Test allows bioLytical to commence production of the new test kits and as a result bioLytical is now working with customers to rapidly distribute the test to support the growing demand for antibody testing around the globe.

“Reliable and truly rapid antibody tests are an important part of our response to this global crisis,” said Robert Mackie, Chief Executive Officer. “The INSTI® COVID-19 Antibody Test is a uniquely effective tool and distribution of our one-minute test kits around the globe is a critical step for tackling the spread of this virus.”

The test detects total antibodies to SARS-CoV-2, the virus that causes COVID-19, in only one minute. It is the only test of its kind to use innovative flow-through technology to deliver results, making it far faster than other antibody tests currently available.

With current tests offering lower performance, more complex procedures as well as longer wait times, the INSTI® COVID-19 Antibody Test provides the most cost-effective solution for COVID-19 antibody testing.

The INSTI® COVID-19 Antibody Test is completely portable, does not require additional equipment and can be performed in a multitude of settings with easy-to-interpret results.  Test providers actually have the advantage of running more tests in less time, due to INSTI®’s market-leading speed.

6.12.18

By Rich Nell

Bioinformatics company MedGenome of Foster City, CA, was recognized by the 2018 Best Medtech Breakthrough Award for the development of its OncoPept platform, an advanced genomics-based platform designed to accelerate cancer immune-oncology research.

OncoPept is used by researchers to help identify biomarkers aimed at delivering personalized therapies including more durable, improved and responsive cancer immunotherapy treatments. It offers a personalized cancer therapy approach leveraging a novel T cell receptor binding algorithm to predict personalized cancer vaccine candidates, and provides a high-throughput multi-dimensional view of the tumor microenvironment using NGS (Next Generation Sequencing) based solutions.

“We thank the MedTech Breakthrough Awards for recognizing our research solutions that benefit a global community of patients dealing with various types of cancer. As a leading genomics-based research company, it is our mission to improve health worldwide by developing deep insights into diseases, ultimately leading to treatments and – eventually – cures,” said Dr. Amitabha Chaudhuri, VP, Research and Development at MedGenome.

“The genomics market is incredibly competitive, and we are thrilled to recognize industry innovator, MedGenome, for their breakthrough OncoPept™ cancer immunotherapy biomarker platform,” said James Johnson, Managing Director at MedTech Breakthrough. “MedGenome’s solutions are delivering a truly personalized cancer therapy approach, and we are excited to recognize their platform as our ‘Best Overall Genomics Solution’ award winner in the 2018 MedTech Breakthrough Awards program.”

The MedTech Breakthrough Awards recognize the top companies, people, platforms and products in the health, fitness and medical technology industries today. The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the creativity, hard work and success of health and medical technology companies, services and products.

With over 3,000 global nominations this year for the MedTech Breakthrough Awards, the competition was incredibly fierce. Notable winners from other categories include GE, WebMD, FitBit, Philips, 23andMe, Humana, Abbott, Apple and an impressive list of top companies and startups in the MedTech industry.