Research has found that antibodies to the marker HMGCR are highly specific to myositis and are associated with, but not limited to, statin exposure.
The firm's nanotechnology-enabled, AI-based, machine learning tool identifies biomarkers in blood samples and produces results in 10 to 30 seconds.
The firm is also developing a second system designed to run clinical chemistry tests for low- and medium-volume labs.
The firm reported total revenues of $708,000, down from $898,000 a year ago, and OVA1 sales volume of 1,884 tests, down 22 percent from 2,418 in Q2 2017.
The revenue increase was largely driven by strong international sales of the OraQuick HIV self-test, which helped offset a decline in HCV testing product sales.
With the patented Dual Path Platform as its foundation, Chembio is expanding its commercial and manufacturing capabilities, its CEO said.
A manufacturing defect caused the control line on the affected tests to not display, which can cause test results to be misinterpreted as negative for the presence of amniotic fluid.
VolitionRx has reached a definitive agreement with an investor for the placement of 5 million shares of the firm's stock at $1.80 per share.
The company said Q2 sales increased 11 percent on a currency-neutral basis, driven by growth in both its Life Science and Clinical Diagnostics segments.
Sales were driven by the cardiac testing products acquired last year from Alere and offset a decline in rapid immunoassay sales tied to the flu season.
The tests can detect several species of Borrelia burgdorferi, the tick-borne parasite primarily responsible for all Lyme disease cases in the US.
The deal cover's Sienna's in vitro diagnostic for the detection of the hTERT component of telomerase, a biomarker that aids in the diagnosis of bladder cancer.
The partners will work together to assess the use of rapid diagnostic tests in decentralized primary healthcare facilities in Malaysia.
ProAxsis and a US-based biotechnology company codeveloped the assay as part of an ongoing collaboration. ProAxsis has made its first commercial sale of the test.
The Atellica assay's capability to assist with antibiotic therapy decisions can help address the rising problem of antibiotic resistance, Siemens said.
Product revenues were up 63 percent year over year, while research revenues rose twelvefold. The company placed nine new T2Dx instruments in Q2 2018.
A spin-out of the University of Geneva and Barcelona's Vall d’Hebron Research Institute, the company is focused on protein biomarkers for brain injury.
The researchers argued that fecal immunochemical test could be used as "rule-in" test for patients with ambiguous symptoms.
In addition, Qiagen has partnered with Japan's SRL for companion diagnostic development, and its CareHPV test was added to the WHO list of prequalified IVDs.
The company posted $29.3 million in revenues for the quarter, including $25 million from its tuberculosis business, which grew 17 percent year over year.