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In Brief This Week: Qiagen; Weill Cornell Medicine; Biocept; and More

NEW YORK (GenomeWeb) – Qiagen has received a warning letter from the US Food and Drug Administration regarding its QuantiFeron-TB Gold blood test for tuberculosis diagnosis. The agency said there have been multiple complaints about the test's high rate of false positives and that it has been misbranded, among other violations of federal law. The firm has been given 15 business days to correct the violations and explain how it intends to prevent further such issues from occurring again.

Weill Cornell Medicine announced this week that it has been awarded a $100,000 Grand Challenges Explorations Grant by the Bill & Melinda Gates Foundation to develop maps of 54 international cities — including Stockholm, Shanghai, Hong Kong, New York, Boston, and Moscow — that show their genetic differences and their epigenetic states. The researchers are aiming to study antimicrobial resistance in these cities in order to help city planners and public health officials to make urban centers safer.

Biocept announced this week that it has signed a master services agreement with an unnamed biopharmaceutical company to develop targeted liquid biopsy tests for multiple tumor types and molecular targets. The companies will use Biocept's Target Selector platforms to develop assays for circulating tumor cells and circulating tumor DNA. As the first phase of the agreement has been successfully completed, Biocept said it has qualified for further projects with the company, and will be eligible for milestone payments that could reach $500,000 or more.

Opko Health said this week that its 4Kscore blood test for aggressive prostate cancer risk has received a draft local coverage determination from Medicare administrative contractor Novitas Solutions. The draft LCD proposes to establish reimbursement coverage for patients with PSA levels higher than 3 ng/mL who have not yet had a biopsy, or patients with a PSA level higher than 3 ng/mL who have had at least one prior negative biopsy and are considered to be at higher risk.

Signal Genetics said this week that it has been granted an extension until Nov. 21, 2016 to comply with the Nasdaq's minimum closing bid price requirement of $1 per share. The company said the Nasdaq granted the extension based on Signal meeting the continued listing requirement for market value of publicly traded shares and all other requirements for initial listing on the Nasdaq with the exception of the bid price. If at any time during the additional time period Signal's closing bid price is at least $1 per share for 10 consecutive business days, the issue will be resolved.

Proove Biosciences announced this week that its lab has been accredited by the College of American Pathologists. Proove is now eligible for contracts with federal government organizations and national payers that require such accreditation.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on the GenomeWeb site.