Following its IPO in September, the company is expanding its presence with increased product offerings in the pipeline and a renewed focus on reimbursement and R&D.
The company's point-of-care platform combines clinical chemistry, immunoassays, and hematology technology to run a range of diagnostic tests.
A preliminary analysis lends some support to covering NIPS for pregnancies beyond high-risk, and some payors have expanded coverage.
Medicare contractor Novitas has been considering a limited local coverage determination for the test, which calculates PSA values and determines whether a patient may need a prostate biopsy.
Companies in the AMR space have met resistance from investors and clinicians as a result of conflicting hospital priorities and perceived technology shortcomings.
Specific Diagnostics said it plans to apply CE marking to the Reveal system next year, followed by submission to the FDA for 510(k) clearance.
Industry experts say a receptive market and investor interest in new technologies have spurred the increase in genomics tools and molecular diagnostics IPOs.
The algorithm uses age, sex, and information about troponin concentrations in patients to determine the likelihood of a heart attack.
A recent study from UCSF suggests Abbott's blood-based i-Stat Alinity device may be able to identify TBI that isn't found by a CT scan.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.