Wednesday, February 20, 2019

Very Brief Blog: CMS Launches Podcast Series "Beyond the Policy"

On February 19, 2019, CMS announced it was launching a podcast series, Beyond The Policy.

The first podcast features Chief Medical Officer Dr Kate Goodrich on E&M coding.

See the podcast website here.

See the press release here.

CMS says the podcast will be released via ITunes and GooglePlay.  Take CMS policy discussions with you wherever you go - the beach, the mountains, even overseas.

CMS Twitter feeds include @SeemaCMS and @CMSgov and CMSGovPress .

The CMS blog homepage is here.

Cancer Group Issues Notice and Warning About Medicare's Restrictive NCD Interpretation (Breast Cancer Screening)

In  the past several weeks, there have been an unusual flurry of articles, notices, and sign-on letters raising concern about the implementation of Medicare's March 2018 NCD covering the Foundation Medicine tumor gene panel test, and additional unexpected effects of that NCD.

FORCE - Facing Our Risk of Cancer Empowered - has released a web page about the topic now.  Find it here.

FORCE writes,
"A newly implemented Medicare policy is significantly curtailing BRCA genetic testing for cancer survivors
Medicare has discontinued coverage of germline genetic testing for beneficiaries who don’t have 'recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer.'  "   

FORCE was among 60 signers of a letter of concern to CMS Administrator Seema Verma on January 31, 2019 (here).

If the NCD is used to restrict NGS testing to women with Stage 3-4 cancer, it has big impact.  Most women who have breast cancer and who qualify under Medicare LCDs (and NCCN guidelines) have Stage 1-2 cancer,  when the most preventive actions are possible.  As I noted on January 2, there is a highly disproportionate impact on Medicare beneficiaries of Ashkenazi origin (here).

FORCE Submitted Comments in January 2018, Before NCD Was Finalized

FORCE submitted comments to CMS on January 17, 2018, before the NCD was finalized (here).  The letter describes "current Medicare policies for Germline testing" - e.g. LCDs  (some of almost ten years duration) in every state guaranteeing coverage of germline testing in women with a personal history of cancer and meeting additional NCCN criteria.  (Generally, the LCDs match NCCN criteria for patients with a personal cancer history.  NCCN has other criteria, not recognized yet by Medicare, for familial history without a personal history).

Remarks In Final NCD Clearly Pointed Away from Germline Testing

So far as I can tell, while statute (1862a) requires CMS to provide the public with its data sources and rationales, and answer public comments, there were no germline sources or rationales in the proposed NCD and no response to the FORCE public comments and similar public comments, except two.   The final NCD remarks that germline testing NCCN guidelines are out of scope (Daly, 2017), and remarks that the NCD does not apply to all NGS method tests, but only those for targeted therapeutics.   Both of these remarks are opposite to an interpretation that the NCD applies to germline testing or applies to all NGS method tests.

CMS Transmittal Opened a New Chapter

As discussed clearly by FORCE on its webpage, the status quo was disrupted by a CMS transmittal in November 2018, adding a remark not found in the final NCD, that no other testing by NGS methods was covered (regardless of purpose) if the patient had cancer.   See screen shot:

click to enlarge
 Note: At least on some browsers, this transmittal seemed to be variably accessible on February 20; it should be, here.

This transmittal led to, several public responses:
  • 60-stakeholder sign on letter here
  • ACLA press release here
  • Genomeweb articles both here and here
  • FORCE webpage here

Other News: Investor Calls

Myriad.  The issue was also discussed on Myriad's recent investor call, where the CEO said the chance of this CMS interpretation spreading to commercial payers was "zero." 

(I think this supports my own general remark that the NCD is not reasonable - if the chance of any other informed body agreeing with it and following it is "zero.")

Invitae.  A few days later, Invitae's investor call included these remarks:
"The coverage group at CMS indicated in early January that it interprets the Foundation Medicine NCD, as limiting Medicare reimbursement of germline cancer testing to late stage cancer patients. Leading patient advocacy groups, professional societies, and industry groups, including Invitae, have expressed the view that this is a mistake. 
We're optimistic that this will be resolved in a way that reflects the contribution of germline testing to cancer patients among the Medicare population."
"....We are along with the advocacy groups, all of the professional societies, most of the industry are working hard to explain to the folks that CMS as well as the legislative committees that have oversight responsibility that this is based on a misunderstanding, that really the utility of germline testing is to -- in cancer patients, is to identify those patients with the hereditary syndromes because they have the greatest risk of metastasis and recurrence.

So really the value in germline testing is primarily in the earlier stage patients and we think they -- this is just a misunderstanding and we're sure that given the opportunities to submit evidence, we and the rest of the community can submit plenty to convince them that this was a mistake and that in fact, along the lines of some of the research that [Chief Medical Officer Dr Nussbaum] outlined, if anything, coverage should moving in the other direction."

Tuesday, February 19, 2019

After Two Years, USPSTF Releases Updated BRCA Guidance

USPSTF has a several dozen guidances for preventive services, which are updated variably at 4 to 10 year intervals.  In March 2017, almost two years ago, USPSTF announced it planned an update of its BRCA-related cancer guidance.

USPSTF just released the draft guidance, for public comment, today on February 19, 2019.   While USPSTF accepts comments on draft guidances, changes between draft and final are usually fairly small.

Comment Period Until March 18

Find the draft guidance page here.  The comment period for BRCA related testing is open until March 18, 2019.  There are separate comment channels for "evidence analysis" and "recommendation."

Basic Recommendations Unchanged

The headline news is that the basic recommendation is that women should be screened for high risk family histories, and, if positive, referred to genetic counseling, and, if desired, BRCA testing.  This is unchanged.  There is an insertion that uses ethnicity/ancestry as a trigger point, in addition to having relatives with cancer.

click to enlarge

Also unchanged is the recommendation against routine screening and testing for women without a familial or personal cancer history.   In contrast, a range of articles and opinions have advocated for broader use of BRCA genetic screening (e.g. Beitsch et al., 2019, here, and Yang et al., 2018, here.)

Some USPSTF recommendations have age brackets (e.g. mammography) but the BRCA guidance has no remarks on patient age.

Medicare vs USPSTF vs NCCN Guidelines (!)

Note that these recommendations are dysjunct with Medicare coverage.  Medicare coverage for BRCA (and related) testing is currently only in women with a personal history of cancer.  Medicare coverage follows the first of two tracks of NCCN recommendations; NCCN recommendations have one track for personal history of cancer, and one track for family history of cancer.  USPSTF offers preventive services, so it focuses on care of women without a personal history of cancer.

The summary report at USPSTF contains a lengthy section on guidelines of other bodies - NCCN, ESMO, ACMG, ASCO, etc.  Too late for inclusion, the American Society of Breast Surgeons guideline was just updated in early February (here), recommending testing in all women with breast cancer (CNN here).  (Women with breast cancer wouldn't be part of the USPSTF prevention guidance.)

The USPSTF guidance refers in passing to the multiplicity of testing - multigene panels are available - but these aren't highlighted any further in the recommendation document.  There are a few remarks around page 39 of the 440-page evidence review document. 

For Affordable Care Act Preventive Services, HHS Has Coupled Genetic Counseling with Testing

Based on an HHS ruling shortly after the Affordable Care Act was passed, the ACA preventive benefit for commercial plans must include both genetic counseling and BRCA testing without copay (not only counseling).  Here (archive here).

click to enlarge

Monday, February 18, 2019

Brief Blog: Advanced Genetic Economics: Myriad Models Expanded Carrier Screening Cost Effectiveness

In mid-2018, Myriad Genetics acquired Counsyl, a leading provider of large-panel carrier screening for family planning.   Beauchamp et al., affilliated with Myriad, have published an interesting open-access paper on the cost-effectiveness of 176-condition carrier screening, compared both to no genetic screening, and compared to minimal screening (such as cystic fibrosis + spinal muscular atrophy testing). 

The authors find that expanded carrier screening is cost effective (defined as less than $50,000 per QALY gained).   Find the paper here at Genetics in Medicine, February 2019.


Carrier screening looks to recessive genes with relatively rare frequencies (less than 1 in 50, sometimes less than 1 in 500), so family history is not helpful in selecting genes to be tested.   For several years, AMA CPT has provided a code for "Ashkenazi" carrier panel screening, and in January 2019, AMA released CPT code for pan-ethnic carrier panel screening.*  The codes are:
81412 - Ashkenazi Jewish associated disorders (e.g. Bloom syndrome, Canavan disease, cystic fibrosis, familial dysautonomia, Fanconi anemia group C, Gaucher disease, Tay-Sachs disease), genomic sequence analysis panel, must include sequencing of at least 9 genes including ASPA, BLM, CFTR, FANCC, GBA, HEXA, IKBKAP, MCOLN1, and SMPD1.   
81443 - Genetic testing for inherited conditions (e.g. cystic fibrosis, Ashkenazi Jewish-associated disoders [e.g. Bloom syndrome, Canavan disease, , Fanconi anemia group C, mucolipidosis type VI, Gaucher disease, Tay-Sachs disease], beta hemoglobinopathies, phenylketonuria, galactosemia), must include sequencing of at least 15 genes (e.g. ACADM, ARSA, ASPA, ATP7B, BCKDHA, BCKDHB, BLM, CFTR, DHCR7, FANCC, G6PC, GAA, GALT, GBA, GBE1, HBB, HEXA, IKBKAP, MCOLN1, PAH).
I had some contact as a consultant with the code application for 81443, which took several cycles before being accepted by AMA CPT.

Guideline on Carrier Screening

The ACOG guideline was most recently revised in March 2017, stating:
The goal of genetic screening is to provide individuals with meaningful information they can use to guide pregnancy planning based on their personal values.  Ethnic-specific, panethnic, and expanded carrier screening are acceptable strategies for prepregnancy and prenatal carrier screening.
Beauchamp et al. 2019

The economics paper builds on elaborate genomic database analysis previously published by Counsyl in 2016 (Haque, JAMA 316:734, here.) 

The Beauchamp paper uses extensive carrier rate genetic analysis combined with extensive modeling of future costs, since no one has used carrier screening and then observed actual outcomes for decades into the future.

The economics decision tree is relatively easy to understand:

For example, under ECS testing, large gray box at top, the individual may be at-risk for one of the genes (orange) or not (blue).  If at risk (orange), then they may be an intervention (blue) or not (orange) - and so on.  For intervention rates if a gene was discovered, the authors modeled 77% observed intervention rates, with 50% and 100% used as comparators.

The economics are based on concurrent panel testing for both partners.  Arguably (I think) it can be even a bit more cost-effective to test one partner, and if negative for a recessive gene, stop.  Had this approach been use (I think) the economic results would have trended only better. 

In their Table 1, the authors present disease costs.  For example, the Duchenne/Becker muscular dystrophy track has a recessive frequency (of conception) of 1:3374, lifetime cost of $1.1M, year 0-3 cost of $53,737, and year 0-1 cost of $7013.   This gives weighted lifetime, 3 year, and 1 year costs of $345, $16, and $2.   1- and 3-year cost returns were considered relevant to commercial health plans.  Remember, that is just one of the many conditions modeled, so it is just one track of the full cost/QALY analyses.

Most models produced 3-year cost/QALY as below $50,000, and cost/QALY was similar to BRCA testing in adults (see their Figure 2).

Understandably, cost effectiveness was stronger when lower test prices were used ($500, $1000, and $2000 were modeled). 


* The code was passed in May 2017, making it too late for the January 2018 annual CPT book.  It went through the summer 2018 CMS crosswalk process, with CMS pricing finalized in November 2018.  The code was first published for the 2019 CPT book.  Note that CMS gapfills or crosswalks all new lab CPT codes, whether they are likely to have Medicare use or coverage or not.

Sunday, February 17, 2019

Very Brief Blog: Medtronic, Harvard, Accenture on AI in Healthcare (Webinar March 7)

On Thursday March 7, 2019, watch a webinar cosponsored by Harvard Business Review, Medtronic, and Accenture on the theme:  "How AI Can Change the Future of Healthcare." 

Register here via Medtronic.

The two speakers - Kaveh Safavi and Brian Kalis - are from Accenture's health practice.  Marketed as:
     There is tremendous excitement about how artificial intelligence (AI) could change health care. New AI technologies are being developed to streamline administrative and clinical processes, and venture capital is pouring in to fund dozens of new AI health care startups.
     Accenture investigated the value of several promising AI applications and found that they could create up to $150 billion in annual savings for U.S. health care by 2026.
     On Thursday, March 7, 2019, leaders from Accenture’s health care practice—Kaveh Safavi and Brian Kalis—will share findings from their investigation of AI applications in health care. They will discuss:
  • Which types of administrative and clinical problems AI is best able to help solve
  • Where AI applications are most likely to be adopted and used
  • Which AI applications are likely to deliver the greatest value



In related news, see three outputs from Scripps' Eric Topol - a new UK report, a new Nature article, and a new book - highlighted here.

For digital health "from a Marie Kondo viewpoint," here.

Friday, February 15, 2019

Very Brief Blog x 2: Genetics Firm Agrees to $1.9M Repayment; And Case Where Repayments Are Stayed

Lab Pays Recoupment After Court Case

According to a February 11, 2019, press release from the Department of Justice, GenomeDx Biosciences Corporation agree to a $1.99 million repayment "to resolve allegations that it violated the false claims act...".  GenomeDx is based in San Diego.   Press release here

The press release states that whistleblowers (aka qui tam case) will receive $348,316.  Docketed as United States ex rel. La Fleur et al. v. GenomeDX Biosciences Corp., No. 17-CV-1959 (S.D. Cal.) (e.g. at Pacer here.) 
DOJ states, "The United States alleged that GenomeDx knowingly submitted claims for the Decipher test to Medicare between September 2015 and June 2017 that were not medically reasonable and necessary because the prostate cancer patients did not have risk factors necessitating the test, including pathological stage T2 disease with a positive surgical margin, pathological stage T3 disease or rising Prostate-Specific Antigen (PSA”) levels after an initial PSA nadir."  
This suggests very close application of terminology in a Medicare LCD (L36345).   In other cases, MolDx provides brief coverage parameters in an "article," rather than an LCD, or sets up arrangements with providers that are not necessarily memorialized in a public LCD or article.
Qui tam actions are common in the lab industry.  In a January 2019 article, the SF Chronicle described qui tam employee actions against CardioDx, here.

Case Where Program Integrity Recoupments Are Stayed by Judge Due to CMS Delays

Not new-news, but I ran across a July 2018 article about cases in which recoupments have been stayed by federal judges based on intolerable CMS delays in the appeals process.  Worth being aware of.

Trade journal article here.   If you are issued a recoupment, it is delayed while you are at the first level of appeal (MAC) and second level of appeal (Hearing).   However, if you lose at that point, you're expected to repay the money while you separately pursue an ALJ hearing to get the money back.

In a case involving a $7.5M recoupment against Family Rehab Inc, a federal district court judge ruled that the recoupment had to be "stayed" or put on hold, because CMS was running an egregious backlog and had far exceeded the 90 statutory timeline for an ALJ hearing.   The case sites a 3-5 year backlog, egregiously exceeding 90 days. 

The party was represented by Foley Lardner attorneys Zaitlin, Waltz, and Donovan.

Docketed as Civil Action No. 3:17-CV-3008-K; originating with a ZPIC (Zone Program Integrity Contractor) extrapolation from a $124,000 penalty on 43 manually reviewed claims to a universe of $8M imputed faulty claims.

Read the June 4 temporary restraining order here and the June 28 injunction (against recoupment) here.

Very Brief Blog: Medicare Releases NCD On CAR-T Therapy in Medicare Patients

A few weeks ago, I posted some background and links on Medicare's decision on CAR-T therapy (here).    In September and November 2017, I had posted there were obvious holes and gaps in press articles about supposed value based pricing for this class of drugs (here, here).  Fierce Pharma later reported that "CMS quietly canceled" the rumored, indication-based pricing (here).

On Friday morning, February 15, 2019, CMS released its proposed national coverage determination on CAR-T therapies.   Therapies (whether inpatient or outpatient), are covered, but there are some (commonsensical) requirements on the hospital and the patient must be in a CAR-T outcomes registry.

There is also a clause for coverage that is not necessarily on-label, but endorsed in a compendium.

Early press from Reuters here.  Trade press at Biopharma Dive, here.  Modern Healthcare, here.  MedCity News here.

The full NCD is online at CMS, here.

Full text of the decision is clipped below the break.   For the full NCD, which prints at 56 PDF pages, see online.  Comment is open for 30 days (to 3/17/2019).

Kymriah and Yescarta CAR-T's are not the most expensive CMS drugs; Luxturna is, at $900,000 (here).

The NCD appears to cover autologous treatment (patient's own cells, re-engineered), but there are efforts underway to potentially use non-autologous CAR-T cells also (MedCity, here; companies include San Diego's Allogene Therapeutics).


Wednesday, February 13, 2019

Brief Blog: Scripps Calendars "Future of Individualized Medicine" Conference, March 14-15, 2019

Scripps has scheduled its 2019 "Future of Individualized Medicine Conference (FOIM)," which will be Thursday/Friday, March 14-15, 2019, in La Jolla.  It's the 11th annual event.

See the agenda here.  Registration through March 4 is $450 (on site, $550). 

On the third day, Saturday, March 16, there will be a separate workshop on implementing precision medicine.  For the extra workshop, registration is $450, or for $500, if you also would like PGX testing from OneOme.

Eric Topol chairs the conference; he just supervised a 50-page "Topol Report" for digital medicine in the UK NHS (here).

Conference text clipped below:

Future of Individualized Medicine
March 14-15, 2019 | La Jolla, California

After 11 annual conferences exploring genomic medicine, we’re broadening our scope.

In 2019, the newly renamed Future of Individualized Medicine (formerly Future of Genomic Medicine) conference will expand to include additional perspectives on how to tailor medicine to the individual. Individualized medicine takes into account a person’s genes—and genomics will remain a core topic for exploration and discussion—but it also considers the full spectrum of a person’s uniqueness from their biologic, physiologic, anatomic, lifestyle and environmental information.

The Future of Individualized Medicine conference will thus incorporate perspectives from the emerging fields of digital medicine, artificial intelligence and machine learning, behavioral science and others.

This is truly a multidisciplinary forum designed to accelerate the transformation of medicine.

Tuesday, February 12, 2019

Very Brief Blog: UK NHS Releases 50-page Digital Health Report; Sanofi Joins the Wave

In trade news today, UK NHS releases a 50-page digital health report, aka "The Topol Report."

Download it here.   For coverage at MedCity, here.

For more 2019 Topol, see also
   (1) his article on AI and medicine in Nature Medicine, here, and
   (2) his new book on Amazon, Deep Medicinehere.

In other news, Sanofi appoints a Digital Health Officer here.   Ameet Nathwani MD, is also Sanofi's chief medical officer.  Heather Bell, a McKinsey grad with a PhD from Oxford, holds a similar global digital health title at Sandoz, here.

Nature launches a new Digital Medicine Journal; article here, website here.   See a summary of these topics at Endpoints, here.


For a fifty-minute November 2018 Rock Health panel, Digital Health: Where's the Exit?, YouTube here.  Text here.

For a February 12, 2019, article in NYT about artificial intelligence in physician decision-making, here, based on a Nature Medicine article on a pediatrics AI system here.

For digital health "from a Marie Kondo viewpoint," here.

AMA also has a 100 page report on digital health adoption, here.

Sunday, February 10, 2019

Very Brief Blog: It's Official, HBO Theranos Documentary is March 18

It's official, the Theranos documentary on HBO will premiere on Monday, March 18, 2019.

From Endgadget, here.  From HBO, here and here.

See the trailer here.

For an interesting article at Forbes from a family that knew the Holmes's well (and got sued by them) here.   For a new Vanity Fair article on the "last days" and EH's personality, here.

The "Discoveries in Health Policy" archive of a couple hundred Theranos links from 2006 forward, here.

My blog on how the Theranos book unveiled the rarest of rare events, an true FDA reviewer confidentiality leak, here.

Very Brief Blog: McKinsey Publishes 80 Page Monograph on Precision Medicine "Opening the Aperture"

McKinsey has published an 80-page monograph on precision medicine, "Opening the Aperture" (28 mb). 

See the landing page for an introductory article here.  Click near the bottom to download the full length PDF version.  Authors are Aptekar et al., most in the Silicon Valley office of McKinsey.

Wednesday, February 6, 2019

Brief Blog: Trapelo and Astrazeneca Launch New Approaches to the "Last Mile" in Successful Precision Oncology

This week, an article in Genomeweb highlighted the continuing gaps in clinician knowledge and testing penetration which inhibits precision oncology.  Genomeweb Premium article here.  (Open access at AP, here.)

Around the first of the year, there were a flurry of announcements in the clinical bioinformatics space, such as Illumina announcing a partnership with PierianDx, Qiagen buying Nof1, and Sophia Genetics raising $77M for expansion.   This week, DNAnexus in Mountain View announced a $68M funding round, to deploy Apollo, "platform for multi omics and clinical data science," here.  It had also raised $58M just twelve months ago.

Two more topics in the field, this week.


Genomeweb runs an article on Trapelo, a newly packaged and integrated service from Intervention Insights.   The article describes a partnership with City of Hope, and describes the service as follows:
...An evidence-based clinical decision support system that links healthcare providers, testing laboratories, and payors, giving them access to current, molecular testing information and results interpretation in order to optimize utilization of molecular testing services and offer the most appropriate care to patients.
Company website here.  See a video on the home page.

CEO is Clyde Taylor (here), who recently wrote a Linked In blog on his vision for precision medicine (here).  He previously held a high position with clinical decision support at NantHealth.

click to enlarge

AZ and AZ Oncology ID

This week brought both direct mail, internet advertisements, and a paste-on oncology journal cover about Astrazeneca Oncology ID.  Pitch:  "AZ Oncology ID is your resource for biomarker testing to help patients receive the most appropriate, personalized treatment."  See the website here:    

Another pharma adventure in this space is Navify, from Roche, "a cloud-based workflow product that securely integrates and displays relevant aggregated data into a single, holistic patient dashboard for oncology care teams to review, align and decide on the optimal treatment for the patient."

Myriad Highlights Best-of-Breed Clinical Integration

On the same theme of the last mile in oncology genomics, Myriad's investor call deck includes a slide highlighting their "best of breed" integration with patient costs, E.M.R. integration, availability of consult sessions, tele-education, and results-management provider portal.  Branded as Myriad Complete Pic:


On the same informatics vein, a recent article in Dark Report (12/24/2018) focused on how labs like Quest are strengthening their data analytics and patient management game to provide more integrated and useful information to large payers. 

(And today Google Verily announces it is taking on clinical care in the opioid epidemic with big data, here; similarly here, here.)

Tuesday, February 5, 2019

Brief Blog: Medicare Still Defines High Risk Colon Cancer Syndromes Without Genetics (Party Like It's 1897...)

One of the most important, frequent, and best understood cancer risk syndromes is Lynch Syndrome, which causes elevated risk of colon cancer (here, herehere).  Adequate screening for Lynch Syndrome is considered a public health issue.

Medicare defines inheritance of high risk for colon cancer, however, without any reference to genetics or Lynch syndrome. 

That means, for example, in a family with Lynch syndrome or familial polyposis and four offspring, Medicare blindly classes all four offspring as high risk for colon cancer, regardless of the fact that genetics will "de-select" two of them as not having inherited the relevant dominant gene.

Medicare's benefit system for colon cancer screening (ranging from FIT to colonoscopy to Cologuard) is here.   The regulations, from 1997, defining "high risk Medicare beneficiaries" are here.  Given the lack of genetics, they could as well date from 1897.

It's like they never heard of Gregor Mendel, or Watson & Crick.
Medicare defines High Risk for colon cancer screening as:
  • A close relative has had colorectal cancer OR an adenomatous polyp;
  • A family history of FAP (familial adenomatous polyposis);
  • A family history of hereditary nonpolyposis colorectal cancer;
  • A personal history of adenomatous polyp or colorectal cancer;
  • IBD (Crohn's or ulcerative colitis).
Note that Medicare considers a personal history of Stage 1 or 2 colorectal cancer a justification for annual colonscopy ($1000 plus each year) but (in a current scandal) not a justification for one time only Lynch panel screening (about $700).

Monday, February 4, 2019

Very Brief Blog; Stanford Holds Annual Big Data in Health Mtg; May 22-23, 2019

Stanford has registration up for its annual Big Data in Health meeting, which will be May 22-23, 2019.

Find the home page here: 

2019 speakers are being posted here.  They include Jeff Dean PhD, Senior VP at Google, and Taha Kass-Hout MD, Senior Leader, Healthcare, Amazon, and Don Rucker MD, the National Coordinator for Health Information Technology, HHS.

Early bird pricing to March 22 is $750.  After that, it rises to $1400 (academic discounts available).

Brief Blog: Illumina Trusight Panel at FDA; Breakthrough Status; Pan Cancer + TMB

In lat January 2019, Illumina announced that a version of its Trusight NGS tumor panel is under review at FDA, and further, that FDA had granted it "breakthrough status." 

The test is aiming for "pan cancer" labeling - the same status that the Foundation Medicine FDA CDx test has.  In addition, the test is planned to report tumor mutational burden (TMB). 

So far, there is no FDA-approved pan cancer IVD to compete with Foundation Medicine in both FDA status and pan-cancer profiling.   A pan cancer IVD would be available at large hospitals, academic medical centers, regional reference labs.   If it can be run profitably, it could be a significant competitor to FMI, or at least, shake up the marketplace.

Read More:

Coverage at Med Tech Dive here.  Press release here.  Illumina's most recent quarterly investor call transcript, January 30, 2019, here.  Illumina had 4Q revenue of $876M and free cash flow circa $200M.  Revenue for the year was $3.4B.


In related news, the VA set up a $111M contract (cumulative; 5 years) with Foundation Medicine to provide services to its patients, including F1 CDx, F1 Liquid, F1 Heme - here.