®®NEW YORK (360Dx) – Cambridge, UK-based PredictImmune announced the entry of its first product, PredictSure IBD, into the National Institute for Health and Care Excellence (NICE) Diagnostic Assessment Programme (DAP), an initiative that evaluates new diagnostic technologies and guides people working in the UK's National Health Service in decisions about adopting them.
PredictSure IBD is a CE-marked whole blood test that provides prognostic data in guiding clinical management of inflammatory bowel diseases, including Crohn’s and ulcerative colitis. The test can identify patients at risk of experiencing severe, relapsing disease, and who may benefit from early treatment with biologics.
PredictImmune noted that selection into DAP requires that the product offer substantial benefits to the patient and healthcare system in comparison to existing practice.
Cadex Genomics said this week that it has launched a clinical study to validate the ability of Alibrex, a circulating tumor DNA assay, to predict early non-response to therapy in stage IV cancer patients.
Using qPCR technology, Alibrex detects retrotransposon elements on all 23 chromosomes.
Rocky Mountain Cancer Centers will be first to enroll patients as part of a multicenter study expected to involve more than 500 patients with metastatic non-small cell lung cancer (NSCLC) and metastatic colorectal cancer (mCRC).
Bill Haack, CEO of Cadex Genomics, said that the firm wants to make Alibrex available to physicians who treat stage IV mCRC and NSCLC cancer patients so that the physicians can quickly determine when patients are not responding to therapy.
Such a capability would allow more accurate and earlier informed decisions regarding other treatment options, he said.
Unlike mutational analysis tests, Alibrex does not predict which therapy may work before the therapy is administered. It determines when a therapy is not working shortly after a patient receives the first dose.
VolitionRx this week reported its net loss for 2018 grew to $18.0 million, or $.57 per share, compared to a net loss of $14.8 million, or $.56 per share, in 2017.
In its Form 10-K filed with the US Securities and Exchange Commission, the Belgium-based company said it had no revenues in 2018, the same as in 2017. Its R&D costs rose 36 percent year over year to $10.9 million from $8.0 million, and its SG&A expenses rose 4 percent to $7.0 million from $6.7 million.
VolitionRx ended 2018 with $13.4 million in cash and cash equivalents. Subsequent to the end of 2018, the company's current investors exercised $6.7 million in aggregate amount of outstanding warrants to purchase shares of its common stock, it said.
Servier Group's WeHealth by Servier e-health division has reached a global distribution and development deal with San Diego-based CureMatch. WeHealth will make CureMatch's precision cancer decisionsupport system available to oncologists, clinics, and hospitals worldwide. The companies also will collaborate on software development and clinical trial programs.
Danaher this week announced its board approved a regular quarterly cash dividend of $.17 per share, payable on April 26 to shareholders of record on March 29.
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