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The latest Emergency Use Authorization is for an ELISA-based test for detecting immunoglobulin M antibodies against SARS-CoV-2 in human serum.
News items for the in vitro diagnostics industry for the week of June 29, 2020.
The funding will be used to continue work on a blood-based test for the detection of concussions at the point of care, point of injury, or at a remote testing site.
Investors in the company, formerly known as Vermillion, have agreed to purchase $11 million in unregistered common stock at a price of $3.50 per share.
Of the 28 companies in the index, 18 firms saw their stock prices increase, while 10 firms' share prices decreased.
The Lexington, Massachusetts-based company has launched a two-hour SARS-CoV-2 test on its fully-automated instrument, the T2Dx.
Developed by the Ragon Institute, the ELISA-based test measures antibodies that bind to the receptor binding domain of the SARS-CoV-2 spike protein.
OncoCyte will cease further development of a liquid biopsy test that used an immune system interrogation approach to clarify whether patients’ lung nodules are benign.
The test leverages a novel cancer biomarker that may improve the accuracy and sensitivity of noninvasive bladder cancer testing.
The tests were developed by Psomagen, Acupath Laboratories, and BioTNS, and the nasal swab self-collection kit is offered by Kroger Health.
Irvine, California-based Fluxergy is working with the MGB Center for COVID Innovation to evaluate the firm's research-use-only COVID-19 testing platform.
RenalytixAI's flagship product is KidneyIntelX, which applies artificial intelligence to patient data to aid in the treatment of progressive kidney disease.
Cowen said that Hologic is on track to more than double its Panther system placements to about 500 this year, driven by SARS-CoV-2 test demand.
Proscia'a digital pathology platform allows pathologists to view, manage, and analyze whole-slide images and is interoperable with laboratory information systems.
The firm said in an SEC document that it received an FDA warning letter in connection with the agency's requirements for its Verigene SP instrument.
The PCR-based test is based on the US Centers for Disease Control and Prevention's CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel.
The agency said that KBMO has promoted a serology test based on the use of a dried blood spot kit that it offered to send to patients' homes.
Burning Rock also said it will continue to develop companion diagnostics-related products based on next-generation sequencing technology.
The firm's Inify Prostate Screening product presorts slides in a worst-first order, allowing pathologists to work immediately on the most relevant areas.
The test detects IgG antibodies and has confirmed 100 percent sensitivity and nearly 100 percent specificity, according to the company.
The test is based on the US Centers for Disease Control and Prevention's SARS-CoV-2 panel and detects two regions of the virus' nucleocapsid gene.
Both tests are authorized for use by any laboratory CLIA certified to perform high-complexity tests, according to the FDA.
The Energy and Commerce Committee chairman asked the agency to show Congress all of the state and local plans for COVID-19 testing by July 6.
The investment bank said CareDx's products are gaining traction and that the stock is positioned for 20 percent to 30 percent growth over the next few years.
The firm used the new loan to pay off an older $7.0 million loan and a $3.0 million promissory note held by Qiagen North American Holdings.