FibroTx has developed two proprietary diagnostic platforms that enable measurements of soluble biomarkers directly from the skin surface.
The test is intended for use as the initial screen in the two-step testing process recommended by the CDC for detecting antibodies against B. burgdorferi.
The effort will provide individuals with genetic testing to determine if they have the disorder, and when necessary, with genetic testing counselling.
The firm said that the decline was due to a customer shifting to internalizing genetic ordering, adverse weather, and the loss of an undisclosed commercial payor.
By testing for changes in PCT levels, clinicians can use the assay to assess the risk of a patient getting a lower respiratory tract infection and sepsis.
Selected companies developing innovative technologies and products could receive breakthrough device designation and greater access to FDA guidance.
Metafora is developing a blood test to help with early diagnosis of De Vivo disease, a metabolic disorder associated with glucose transport deficiency.
The tests have received coverage decisions from a number of Blue Cross Blue Shield plans this year including ones in California and New Jersey.
Alere received clearance for the Afinion HbA1c Dx and for the Alere i Strep A 2, a rapid molecular test for the qualitative detection of Streptococcus pyogenes.
Illumina has extended a supply agreement with Foundation until 2023 and developed an automated metagenomics workflow with PerkinElmer.
The company said it plans to use the net proceeds for general corporate purposes, including for working capital and possible acquisitions.
The designation will help the company accelerate the process of bringing the opioid addiction risk test through regulatory review and clearance.
The agreement grants MDxHealth the rights to manufacture and market the phosphodiesterase-4D7 biomarker as a prognostic test.
Makers of genetic health risk tests will only need one FDA review before commercializing tests, with some exceptions.
The firm sold about about 7 million shares of its common stock at $7.50 per share, including 915,000 shares to the offering’s underwriters also for $7.50 per share.
The partners will develop next-generation sequencing-based tests for precision cancer treatment for the Asian market.
The study solidified how doctors should interpret and act upon an intermediate result from the breast cancer risk test in how to treat early-stage patients.
In a lawsuit filed in the US District Court in Maine, Copan alleged that Puritan infringed patents on core flocked swab technology used to collect test samples.
The test is Micronics’ first to receive FDA clearance, and the company is pursuing CE marking for it and the PanNAT system.
Rosetta had disclosed that it intended to file for bankruptcy after its merger with Genoptix was not completed as planned.