Molecular diagnostics company Oncocyte and Chronix Biomedical have entered an agreement under which Oncocyte will license Chronix’s patented CNI Monitor technology for the TheraSure-CNI Monitor clinical assay. The partnership aims to advance Oncocyte’s work in cancer care by adding Chronix’s blood-based test to Oncocyte’s existing portfolio of tests.

The TheraSure-CNI Monitor assay will utilize copy number instability (CNI) to analyze a cancer patient’s blood sample for DNA sequences associated with cancer. The CNI score will allow healthcare professionals to assess patients’ response to therapy and then determine the best treatment options for each patient.

“By identifying early resistance of a tumor to immune therapy drugs, this technology could provide useful information that may allow physicians to rapidly adjust patients’ therapies to optimize the immune system’s power to fight cancer. The rapid expansion of immune therapy options presents many choices for physicians. Thus, quickly assessing the effectiveness of therapies can be a game-changer for patients,” said Ron Andrews, president and CEO of Oncocyte.

Through the partnership, Oncocyte will join the market of therapeutic response monitoring in cancer care and use Chronix’s network in Germany to commercialize its current chemotherapy treatment selection test, DetermaRX.

Abingdon Supplies SARS-CoV-2 Rapid Antibody Test to U.K. Government

The United Kingdom government has placed an order for 1 million SARS-CoV-2 rapid antibody tests as part of its newly formed contract with Abingdon Health.

Abingdon Health’s recently developed AbC-19 Rapid test enables patients to test themselves with results returned in just 20 minutes. The testing kit provides patients with supplies to collect a blood sample via fingerprick and apply it to a test card to show positive or negative results without leaving home. The test has already received the CE mark in the U.K. and European Union and is being mass-produced.

“Our test will help give a picture of how many people in the U.K. have antibodies. This will be a crucial part of the understanding of immunity to COVID-19,” said Chris Yates, CEO of Abingdon Health. “Mass testing will also help understand what the longevity of immunity is and, in time, help assess the efficiency of any vaccine on the market. In this respect, high-quality mass antibody testing has never been more important, and it will be critical for future public health responses.”

The AbC-19 Rapid test was developed from Abingdon Health’s U.K.-Rapid Test Consortium, supported by the U.K. government as a way for scientists and medical manufacturers to deliver mass testing kits as quickly as possible.

LabCorp and Genfit Team for NASH Diagnosis

LabCorp and the biopharmaceutical company Genfit have signed a 5-year contract to integrate Genfit’s NIS4 technology with a blood-based molecular diagnostic test developed by LabCorp. The two companies aim to better identify patients at risk for nonalcoholic steatohepatitis (NASH).

NASH is defined as nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥4 and fibrosis stage ≥2. The NIS4 technology is specifically designed to diagnose patients at risk for NASH through a multi-biomarker-based algorithm. Clinical laboratories will be able to detect the condition by a single test score generated from four biomarkers, miR-34a-5p, alpha-2-macroglobulin, YKL-40, and HbA1c.

Research shows that NASH remains one of the fastest growing medical conditions in the U.S. Currently, the standard diagnosis method for NASH is a highly invasive liver biopsy procedure.

The partners have begun using the NIS4 technology for clinical studies and plan to commercialize the test across the U.S. and Canada.

Stool Test Provides Accurate Gut Microbiome Analysis

CosmosID and Microbiome Labs have collaborated to further develop BiomeFx, a stool test that evaluates the gut microbiome.

Through sequencing technology, BiomeFx analyzes pathogens and species for a closer look into gut microbiota composition, which the companies say could help physicians ensure their patients have proper gut microbiome functionality. The firms also expect the test will speed up detection of disorders involving the gut microbiome.

“We see a growing demand for gut microbiome tests that are sufficiently accurate and functionally informative to enable healthcare professionals to deliver on the promise of personalized healthcare and nutrition. Conventional stool tests rely on methods that are either limited to only detecting a small part of the gut microbiome or that fail to identify gut microbes correctly and with species and subspecies level resolution,” said Manoj Dadlani, CEO of CosmosID.

BiomeFx was first launched in March and has been widely distributed to healthcare professionals across the U.S.

DARPA Awards $1.1 Million for COVID-19 Severity Test

The Defense Advanced Research Projects Agency (DARPA) has awarded molecular diagnostics company Inflammatix with $1.1 million to further develop its host-response diagnostics, which predict severity of COVID-19 in patients.

Through a machine learning approach and multiple mRNA biomarkers, Inflammatix’s CoVerity COVID-19 Severity test quickly reads a patient’s immune system to determine the risk of respiratory failure. According to the company, this testing approach has proven highly accurate in comparison to other clinical biomarkers.

Inflammatix—winner of the 2019 AACC Disruptive Technology Award—expects the test to help healthcare workers make better decisions about which patients should be hospitalized.

“While major progress has been made in developing rapid platforms to diagnose SARS-CoV-2 infection, predicting severity in COVID-19 patients remains an unmet medical need,” said Evangelos J. Giamarellos-Bourboulis, MD, professor of Internal Medicine and Infectious Diseases at Attikon University General Hospital, chairman of the European Sepsis Alliance, and president of the European Shock Society. “Existing tools have shown limited accuracy in enabling us to confidently identify high-risk patients early who need close monitoring or discharge non-severe patients to recover at home.”

Quanterix and Abbott Enter $10 Million License Agreement

Quanterix, a company centered around digitizing biomarker analysis, has entered a license agreement with Abbott Laboratories. Under the agreement, Abbott will gain access to Quanterix’s bead-based technology patents for use in in vitro diagnostics applications.

Though the companies have not disclosed many details regarding what the agreement would center around, Quanterix’s technology has been used previously in therapeutic areas such as oncology, neurology, cardiology, inflammatory, and infectious diseases. “The agreement is an important step forward for Quanterix,” said Doug Schenkel, research analyst at Cowen. “The partnership with Abbott validates Quanterix’s technology potential in the diagnostics market and should continue to help build investor confidence that the opportunity is real.”

The agreement provides Quanterix with an initial $10 million license fee, milestone fees subject to Abbott achieving development, regulatory, and launch milestones, and royalties on the sales of licensed products.

Experts believe the partnership will also provide an opportunity to explore COVID-19 applications of Quanterix’s technology.