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In Brief This Week: Quest, FDA, Millennium Health, Genalyte, and More

NEW YORK (360Dx) – Quest Diagnostics this week announced plans to acquire Mobile Medical Examination Service, a provider of home-based health risk assessments and related services.

The company said the acquisition will expand its scale and reach in the mobile and home segment and will bolster its services in the extended-care space.

MedXM employs more than 1,700 medical professionals who focus on early detection of disease by assessing patients for health risks, often in their homes. MedXM works with patients of health plans, in particular Medicare Advantage and Medicaid, and helps gather data from assessments for risk scoring and quality tracking of populations.

Quest CEO Steve Rusckowski said that by helping Quest reach customers where it is more convenient for them, the acquisition will support the company's strategy of becoming more consumer friendly. The transaction is expected to be completed in the first quarter. Financial terms were not disclosed.


The FDA said this week it is extending the comment period for two of its draft guidances to March 30. One draft guidance is the Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices — Draft Guidance for Industry and Food and Drug Administration Staff. The other is Recommendations for Dual 510(k) and CLIA Waiver by Application Studies — Draft Guidance for Industry and Food and Drug Administration Staff.

These guidances were published on Nov. 29, 2017 to help manufacturers of IVD devices apply for and receive CLIA waivers.

The first document will represent the agency's policy on the appropriate use of comparable performance between a user in a waived facility and a user in a moderately complex laboratory to demonstrate accuracy. The second document will describe the agency's expectations regarding study designs for generating data that supports both 510(k) clearance and CLIA waiver by application.


Millennium Health said this week it has received CAP accreditation. The accreditation "demonstrates that [it] has attained the highest standard of excellence in laboratory practices and indicates the laboratory meets these high-quality standards for the DxWound molecular microbiology test," the firm said.

The test is offered by CogenDx, the genetics brand of Millennium, and detects microbes, including aerobic and anaerobic bacteria, fungi, and antibiotic resistance genes. Millennium was previously CAP-accredited for molecular pathology, chemistry, and toxicology testing.


Genalyte announced this week that it received ISO certification for manufacturing medical devices, which supports the firm's cloud laboratory diagnostic testing model. Genalyte's system brings blood-based diagnostic testing to the physician's office, offering results in about 15 minutes, the firm said.


Exosome Diagnostics this week entered into a preferred provider network agreement with America's Choice Provider Network (ACPN). Under the terms of the agreement, more than 28 million ACPN members from across the US will have access to and coverage for Exosome Dx's ExoDxProstate(IntelliScore), a urine test developed to help reduce the number of unnecessary prostate biopsies.


Luminex this week declared a cash dividend for the first quarter of $.06 per share, payable on April 13 to stockholders of record as of the close of business on March 23.


PerkinElmer this week declared a regular quarterly dividend of $.07 per share of common stock, payable on May 10 to all shareholders of record at the close of business on April 13.


Becton Dickinson this week declared a quarterly dividend of $.75 per common share, payable on March 30 to holders of record on March 9. The indicated annual dividend rate is $3 per share. BD has also declared a quarterly dividend of $15.31 per share on 6 percent mandatory convertible preferred stock, Series A, payable on May 1 to holders of record on April 13.


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 360Dx site.