FDA open to whole-slide imaging as class II device
The Digital Pathology Association says that manufacturers interested in marketing whole-slide imaging devices for primary diagnosis in the U.S. should submit de novo applications to the Food and Drug Administration. Until recently, the association had suggested that manufacturers of WSI devices submit premarket applications, which are required before class III medical devices can be marketed. The new recommendation is based on discussions with the FDA.
The FDA had previously stated it considered whole-slide imaging for primary diagnosis to be a class III medical device, but it had never formally classified these devices. Under certain circumstances, manufacturers can opt to submit a de novo application for a moderate- or low-risk device that has not yet been classified and for which there is no predicate device. If the FDA authorizes the marketing of a device based on a de novo application, the device will then become classified, generally, as a class II device, the DPA said. Once a de novo application receives marketing authorization, other companies will then be able to submit 510(k)s for whole-slide imaging.
The DPA regulatory task force has had extensive discussions with the FDA, since 2014, under the presubmission process. The task force consists of regulatory experts from the member companies of the DPA, as well as two pathologists, Eric Glassy, MD, and Anil Parwani, MD, PhD. The DPA also contracted with Jeffrey Gibbs, an attorney with expertise in FDA law from the firm of Hyman, Phelps, and McNamara, to advise the task force.
“The possibility that WSI for primary diagnosis could become a class II device is a significant step forward for the industry,” Michael Montalto, PhD, senior vice president of clinical and medical affairs for the digital pathology company Omnyx, said in a statement.
“The FDA has been very open and responsive and has given the DPA clear guidance on classification and associated special controls,” said Dr. Montalto, who has chaired the DPA regulatory task force since 2013.
“It is important to realize that WSI for primary diagnosis is still deemed a class III device,” Gibbs said in the DPA’s statement. “Only after a first application receives marketing authorization by the FDA would it become a class II device. The FDA still reserves the right to keep the devices as class III until an application demonstrates reasonable assurances of safety and effectiveness in combination with general and special controls.”
In order for a new type of medical device to be considered a suitable candidate for a de novo application, a device manufacturer must establish that the device meets specific criteria, including an appropriate benefit-risk profile. The risks of the device must be well understood and mitigations need to be developed, including special controls, to give reasonable assurances of device safety and effectiveness.
In early 2015, the DPA regulatory task force submitted documents explaining its position that class II status was appropriate for whole-slide imaging intended for use in primary diagnosis. The DPA subsequently has met with the FDA to discuss class II status and has submitted a proposal for special controls for FDA consideration. The DPA and the FDA held several meetings over the course of 2015, culminating in a statement by the FDA at the most recent meeting that whole-slide imaging is a candidate for de novo application.
“The open and collaborative dialogue among pathologists, manufacturers, and the FDA has been remarkable and unprecedented,” Dr. Glassy said in a statement. “Industry and pathologists have spoken with one voice and the FDA has responded with a framework that will benefit our specialty and, more importantly, our patients.”
The DPA and the FDA plan to continue to discuss special controls and other relevant matters related to de novo applications in forthcoming meetings.
In a separate announcement, Omnyx officials cheered the news of the FDA’s willingness to consider a less burdensome approach to approval.
“Patients deserve the peace of mind that comes with knowing their doctors have made their diagnosis by utilizing all of the information available to them,” Omnyx CEO Mamar Gelaye said. “And, because cancer waits for no one, we have to act with a sense of urgency. Lives can depend on it.”
“Omnyx applauds the DPA for its tireless efforts and acknowledges the FDA’s willingness to constructively engage with members of the digital pathology community on this important matter,” said Larry Kopyta, the company’s senior vice president of quality assurance and regulatory affairs.
Siemens’ high-volume coag analyzer cleared
The FDA has granted 510(k) clearance to Siemens Healthcare’s Sysmex CS-5100 hemostasis system. Officials at the company say the system, in use around the world since 2012, will shake up the U.S. market for coagulation analyzers through its standardized sample management and automated detection of unsuitable samples.
“A lot of people, particularly in the coagulation laboratory, do keep their analyzers for a long time. It’s not like chemistry where they are changing every five years,” says Jackie Hauser, MT(ASCP), director of hemostasis and hematology in Siemens’ U.S. laboratory diagnostics marketing division. “The technology really hasn’t changed that much in coag over the years. But with the introduction of this new technology, laboratories will be able to automate and standardize how they deal with sample processing.”
The Sysmex CS-5100 can detect hemolyzed samples and underfilled tubes, among other preanalytical errors that can lead to falsely elevated or decreased results.
“The analyzers really didn’t have, in the past, a way of telling you whether that blue top was filled to the line or not,” Hauser says. “It may have a liquid level sensor but it’s not married up to the technology that tells you which blue-top tube is incorrectly filled. This is very new for us in the U.S.”
That automation saves precious time, Hauser says.
“To peel off a label [to determine proper fill] may take only three or five or 10 seconds, but it can add up” in high-volume laboratories, she says.
The analyzer has onboard capacity of up to 3,000 tests and up to 40 reagents. Hauser also touted the system’s ability to connect with Siemens’ automation and data-management offerings, including the track-based Aptio and Advia LabCell automation solutions. The system also comes equipped with the ability to conduct simultaneous multiwavelength sample-integrity checks.
“Multiple wavelength analysis lets the analyzer pick the best wavelength for the test and that sometimes eliminates the effect of interfering substances like hemolysis,” Hauser says. —Kevin B. O’Reilly[hr]
With Alere purchase, Abbott claims POC test mantle
Abbott and Alere announced a definitive agreement for Abbott to acquire Alere. Under the terms of the agreement, Abbott will pay $56 per common share at a total expected equity value of $5.8 billion. In a statement, Abbott said the transaction, once completed, will make it the leading diagnostics provider of point-of-care testing. Abbott’s total diagnostics sales will exceed $7 billion after the close.
The combined business will offer a broad point-of-care menu of infectious disease, molecular, cardiometabolic, and toxicology testing, expanding Abbott’s platforms to include benchtop and rapid strip tests. More than half of Alere’s $2.5 billion in sales are in the United States. Waltham, Mass.-based Alere delivered more than 1.4 billion tests at the point of care in 2015. The transaction, which has been approved by the boards of directors of Alere and Abbott, is subject to the approval of Alere shareholders and the satisfaction of customary closing conditions, including applicable regulatory approvals.[hr]
$1.3 billion for Affymetrix
Thermo Fisher Scientific will buy cellular and genetics analysis products company Affymetrix for $14 per share in cash, which represents a purchase price of about $1.3 billion.
Affymetrix, based in Santa Clara, Calif., has about 1,100 employees worldwide and maintains sales and distribution operations primarily in the U.S., Europe, and Asia. The business, which has annual revenues of about $350 million, will be integrated into Thermo Fisher’s life sciences solutions segment.
The purchase has been approved by both companies’ boards of directors. The transaction is expected to close before the summer of 2016 and is subject to the approval of regulators and Affymetrix shareholders.[hr]
Illumina pursues blood-based cancer screening
Illumina has announced Grail, a new company formed to enable cancer screening from a simple blood test. Powered by Illumina sequencing technology, Grail will aim to develop a pan-cancer screening test by directly measuring circulating nucleic acids in blood.
Grail has been formed as a separate company, majority-owned by Illumina. Grail is initially funded by more than $100 million in series A financing from Illumina and Arch Venture Partners, with participating investments from Bezos Expeditions, Bill Gates, and Sutter Hill Ventures. Grail’s unique relationship with Illumina makes it possible to economically sequence at the high depths needed to create a screening test with the required sensitivity and a hoped-for level of specificity not yet achieved in cancer screening, according to an Illumina statement.[hr]
45% of pathologists report burnout
An online survey of more than 15,000 American physicians has found that nearly half of pathologists, 45 percent, reported burnout from their lives in medicine. However, that compared favorably to many other specialists surveyed by Medscape last fall, with critical care, urology, and emergency medicine leading the pack of 25 specialties profiled with 55 percent rates of burnout.
According to the “Medscape Lifestyle Report 2016,” pathologists ranked their level of burnout as 4.1 on a scale of five. That was lower than all but three other specialties—dermatology, rheumatology, and psychiatry. Critical care again scored tops, with a 4.7 level of burnout. There was a gender split in burnout among pathologists, as half of women reported burnout, compared with 39 percent of men in the specialty.
Bureaucracy, long hours, and “income not high enough” led the pack as contributors to burnout in pathology.
The full report, published Jan. 13, is available to Medscape registered users at http://j.mp/pathologylife. Registration is free. —Kevin B. O’Reilly
CMS cites deficiencies at Theranos lab
The Centers for Medicare and Medicaid Services sent a Jan. 25 letter giving laboratory startup Theranos 10 days to correct condition-level deficiencies in hematology, analytic systems, laboratory leadership, and personnel at its Newark, Calif., location. In hematology, the CMS said the problems “pose immediate jeopardy to patient health and safety.”
In reaction to the news, Theranos partner Walgreens said the laboratory must “immediately cease” sending Theranos Wellness Center tests to its lab in Newark, Calif. The drugstore chain also suspended Theranos laboratory services at Walgreens’ Palo Alto, Calif., store. Pennsylvania insurer Capital BlueCross suspended Theranos blood draws at the health plan’s Enola, Pa., retail location.
In a statement, Theranos noted the CMS letter does not apply to its Arizona laboratory, where more than 90 percent of the company’s tests are performed. At CAP TODAY press time in early February, the CMS granted Theranos an extension until Feb. 12 to submit its correction plan.