Thermo Fisher Scientific announced it will acquire the molecular diagnostics-focused firm Qiagen for $11.5 billion.

Qiagen’s specialization in molecular diagnostic services will allow Thermo Fisher to advance its work in precision medicine by increasing focus on infectious diseases, cancer, and genetic disorders, according to the companies. Specifically, Thermo Fisher plans to expand utilization of Qiagen’s Quantiferon-TB Gold Plus latent tuberculosis detection test, the QiaSymphony platform for molecular diagnostics infectious disease testing, and the QiaStat-Dx syndromic testing system. These platforms add to Thermo Fisher’s existing portfolio of quantitative polymerase chain reaction, next-generation sequencing, Sanger sequencing, and microarray technologies.

Thermo Fisher will also take advantage of Qiagen’s sample prep technologies, assays, and bioinformatics solutions to expand its life sciences products, including existing reagents and consumables.

"This acquisition provides us with the opportunity to leverage our industry-leading capabilities and [research and development] expertise to accelerate innovation and address emerging healthcare needs," said Marc Casper, chairman, president, and CEO of Thermo Fisher Scientific. The deal is expected to be finalized in 2021.

Qiagen recently announced development of its QiaStat-Dx Respiratory SARS-CoV-2 Panel test for diagnosing patients with COVID-19. The Food and Drug Administration granted Qiagen an emergency use authorization for the test that can differentiate the SARS-CoV-2 coronavirus from 21 other respiratory pathogens in patients. Using nasopharyngeal swab samples, the test specifically targets two genes that help detect the COVID-19 pathogen.

Biodesix, Bio-Rad Seek EUA for COVID-19 Test

Biodesix and Bio-Rad Laboratories have partnered on a droplet digital polymerase chain reaction (ddPCR) test for SARS-CoV-2. At CLN press time, the companies were hoping to gain Food and Drug Administration emergency use authorization (EUA) for this test.

Some laboratories have been using quantitative PCR (qPCR) tests for patients who show symptoms of COVID-19. However, two recent studies in China found that the ddPCR test can be significantly more sensitive in diagnosing patients before symptoms develop.

The studies showed that patients who underwent qPCR tests had the possibility of showing false negatives or false positives. The studies also saw a difference in accuracy with detection numbers increasing from 28.2% with qPCR tests to 87.4% with ddPCR tests. Though the studies have not been peer reviewed, both companies intend to begin offering this test in the U.S. once they receive EUA.

Grant Funding Goes to Tuberculosis Detection Assay

Following an initial $500,000 grant from the Bill & Melinda Gates Foundation, Biological Dynamics announced a secondary grant of about $1 million from the foundation for a tuberculosis (TB) detection assay. The molecular diagnostics company previously began working on the TB assay to target countries with limited access to medical testing laboratories.

With Biological Dynamics’ Verita lab-on-chip platform, experts are able to pinpoint nanoparticles and micro-molecules of a specific size in blood, plasma, or serum without interference from smaller or larger particles. The platform also eliminates complex and time-consuming processes. The company intends to offer the assay for early detection of TB with a strong focus on geographic areas that lack diagnostic resources.

Having raised $50 million in funding so far, Biological Dynamics also said its team of 38 employees is working on ways to improve rapid diagnoses of cancers and other diseases such as glioblastoma and Alzheimer’s disease.

PerkinElmer, Public Health England Partner on Newborn Screening

PerkinElmer and Public Health England have teamed to advance newborn screening for severe combined immunodeficiency (SCID). Public Health England has agreed to use PerkinElmer’s VICTOR EnLite instrument, as well as the EnLite Neonatal TREC kit to evaluate newborns.

SCID can be severely debilitating, even causing death. However, if detected early enough in newborns, it can be treated through stem cell transplants from family members.

By using PerkinElmer technologies, Public Health England expects to improve efficiency in diagnosing SCID. The instrument and kit are capable of determining the T-cell receptor excision circle (TREC), a primary biomarker of SCID, and the TREC kit reduces typical laboratory steps involved in newborn screening.

Companies Collaborate on Remote Sample Collection

To reduce the need for patients to visit transplant centers during the COVID-19 pandemic, Transplant Genomics has announced a partnership with Eurofins Viracor to remotely collect samples from kidney transplant recipients. Along with Eurofins Viracor, Transplant Genomics has also formed relationships with Quest Diagnostics and other mobile collection providers to offer services to patients.

With remote sample collection, patients are still able to receive the same testing and analysis that they would by visiting labs. The companies are remotely providing testing services for Transplant’s TruGraf blood test and Eurofins’ TRAC liquid biopsy test. The TruGraf blood test allows surveillance to rule out silent rejection in stable kidney transplant recipients and also determines if patients are immune quiescent. Additionally, the TRAC test analyzes donor-derived cell-free DNA levels in blood to help rule out rejection.

Patients can directly contact either company to request remote sample collection services.

Collaboration Tackles Point-of-Care Testing for COVID-19

Heat Biologics and the University of Miami have joined forces to develop a point-of-care (POC) diagnostic test for COVID-19 that the parties say will expand rapid testing compared to traditional methods. The partners also plan to develop the test as a less expensive alternative for both manufacturers and patients.

The POC test uses a pharyngeal throat swab and will show results on a paper strip in under 30 minutes, according to the University of Miami. This method will also use isothermal amplification technology to detect viral nucleic acids.

“Our lab has tremendous experience developing accurate and easily usable tests for infectious diseases such as human papillomavirus and Zika,” said Sylvia Daunert, test co-developer and chair of biochemistry and molecular biology at the University of Miami Miller School of Medicine. “Our test is being developed to utilize molecular recognition and amplification of the target virus. This should allow for much earlier detection, providing critical and time-sensitive information to help curb the spread of the disease.”