NEW YORK – Thermo Fisher Scientific said this week that the US Food and Drug Administration has granted Breakthrough Device Designation for its Oncomine Precision Assay to identify low-grade glioma patients with isocitrate dehydrogenase 1 and 2 mutations and who may be eligible for treatment with vorasidenib (AG-881). The assay is designed to run on the Ion Torrent Genexus sequencing platform. Thermo Fisher is codeveloping a companion diagnostic for vorasidenib with Agios Pharmaceuticals. Thermo Fisher said it eventually plans to apply for premarket approval for the Oncomine Precision Assay as a companion diagnostic for multiple therapies, for liquid-biopsy tumor profiling in lung cancer, and for solid-tumor profiling in multiple cancer types.
Myriad Genetics announced this week that it has received positive coverage decisions for its prostate cancer aggressiveness test Prolaris from three commercial insurers that cover a combined 26 million lives. The company said Aetna and BlueCross BlueShield of Tennessee issued policies, but it did not name the third payor.
In a policy that took effect on June 8, Aetna said it would cover Prolaris for men who have very-low risk, low risk, and favorable intermediate-risk prostate cancer, who have not previously been treated, have a greater than 10-year life expectancy, and are candidates for active surveillance; and for men with intermediate-risk prostate cancer who are considering adding androgen deprivation therapy to their radiation treatment.
In a policy that takes effect on July 31, BlueCross BlueShield of Tennessee said when certain conditions are met, it would cover array-based gene expression tests for risk stratifying prostate cancer patients, such as Prolaris, Genomic Health’s Oncotype DX Prostate Cancer Assay, Metamark Genetics’ ProMark Protein Biomarker test, and Decipher Biosciences’ Decipher Prostate Cancer Classifier. Decipher, Oncotype DX Prostate, Prolaris, and ProMark are covered for men who have low or favorable intermediate-risk disease with a life expectancy of at least 10 years; Decipher or Prolaris are covered when men have unfavorable intermediate or high-risk cancer and life expectancy of at least 10 years; and Decipher is covered for men with high-risk disease where adverse pathology is found on radical prostatectomy.
Fulgent Genetics said this week that the US Food and Drug Administration updated the Emergency Use Authorization granted to the company’s SARS-CoV-2 test in May. Fulgent is now authorized to offer consumer-initiated SARS-CoV-2 testing with Picture Genetics’ COVID-19 Home Collection Kit. Picture Genetics is Fulgent's consumer-facing subsidiary. Individuals interested in ordering the test must qualify through an online screening process, which makes determinations based on US Centers for Disease Control guidelines. Fulgent has partnered with an unnamed national clinician network to oversee the process, monitor materials, and review reports provided to patients.
CareDx said this week that it has closed a previously announced public offering of 3,906,250 shares of its common stock at a public offering price of $32.00 per share. In addition, the company granted the underwriters a 30-day option to purchase up to 585,937 additional shares of its common stock, and the underwriters exercised this option in full. CareDx expects net proceeds from the offering of approximately $117.1 million, plus an additional $17.6 million from the exercise of the underwriters’ additional shares.
The company said it intends to use the net proceeds for working capital and general corporate purposes.
Goldman Sachs and Jefferies acted as joint book-running managers, and BTIG and Craig-Hallum Capital Group acted as co-managers.
Binx Health this week announced a partnership with UK-based Polar Speed to enable patients there to collect a throat or nasal swab specimen at home for COVID-19 testing. Using Boston-based Binx's testing solution, patients will be able to provide a sample and Polar Speed will pick it up at the patient's doorstep and deliver it to a laboratory for testing. The partnership covers the UK, including individuals, businesses pursuing return-to-work strategies, and employee monitoring programs. Polar Speed is a specialist UPS Healthcare business in the UK. Financial and other terms of the deal were not disclosed.
The US National Institutes of Health said this week that it will test blood samples of recent participants of the All of Us Research Program to seek new insights into COVID-19. Samples from 10,000 or more participants who have joined the program since March will be tested with a coronavirus antibody test to assess the prevalence of exposure to COVID-19 among participants in the program and help estimate the varying rates across regions and communities. The program will look for IgG antibodies using a test that received Emergency Use Authorization from the US Food and Drug Administration. Positive samples will be tested further to assess whether the positive result is due to the coronavirus specifically and to assess the level of the immune system's response, the NIH said. Collaborators in the study include the Frederick National Laboratory for Cancer Research, supported by the National Cancer Institute; the National Institute of Allergy and Infectious Diseases; the Centers for Disease Control and Prevention; and Quest Diagnostics.
Molecular diagnostics firm Mobidiag said this week that it has received the second tranche of €10 million ($11.3 million) from a €25 million loan obtained from the European Investment Bank Group (EIB) in May 2019. The Finland-based company said it will use the funds to advance its R&D efforts and facilitate further validation and commercialization of new molecular diagnostics tests using its Amplidiag and Novodiag platforms.
North Carolina-based health system Vidant Health said this week it has selected GenMark Diagnostics as its primary provider of rapid testing for SARS-CoV-2 and other infections. Vidant is deploying GenMark's ePlex system across all nine of its hospitals to test for SARS-CoV-2, other respiratory pathogens, and bloodstream infections.
Vidant Health is currently using the ePlex SARS-CoV-2 test and will transition to the ePlex Respiratory Pathogen 2 (RP2) panel when GenMark applies for Emergency Use Authorization of the panel to the US Food and Drug Administration, GenMark said. The ePlex RP2 Panel is designed to test for SARS-CoV-2 and other common respiratory infections, including influenza, pneumonia, rhinovirus, and respiratory syncytial virus.
The Central Authority of the German Länder for Health Protection with regard to Medicinal Products and Medical Devices this week designated TÜV SÜD Product Service as a notified body under the new In Vitro Diagnostics Regulation (IVDR). It is Germany’s second notified body and the fourth overall designated under the IVDR, which takes effect in May 2022. As Europe transitions to the new regulations, in vitro diagnostics will need to be cleared by notified bodies. A dearth of such designated standards organizations has led some to question whether it will lead to a bottleneck that could potentially delay the availability of IVD tests.
IDbyDNA announced this week that Gatot Soebroto Army Hospital in Jakarta, Indonesia, is implementing IDbyDNA's Explify Platform for the detection of SARS-CoV-2 and other pathogens in patients with COVID-19. The company’s Explify Platform will be used to analyze tens of thousands of cases throughout hospitals and institutes in Indonesia and will provide SARS-CoV-2 genomic information, including about genetic mutations of viral strains from patient samples that can be used to track the virus.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.